<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02235064</url>
  </required_header>
  <id_info>
    <org_study_id>CUH IRB#: 14-078</org_study_id>
    <nct_id>NCT02235064</nct_id>
  </id_info>
  <brief_title>Prophylactic Use of Postpartum Sertraline to Prevent Postpartum Depression</brief_title>
  <official_title>Prophylactic Use of Immediate Postpartum Sertraline to Prevent Postpartum Depression: A Double Blind Randomized Placebo Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cooper Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cooper Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this project is to assess the effectiveness of preventative antidepressants&#xD;
      immediately following delivery on postpartum depression rates in women at high risk due to&#xD;
      prior history of depression or postpartum depression.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible women for our study would be identified antepartum from our three obstetrical groups&#xD;
      delivering at Cooper University Hospital: Cooper Faculty Group, Women's Care Center, and&#xD;
      CamCare. Potentially eligible women would be referred to the study coordinator or principal&#xD;
      investigator to discuss the nature of the study. Those women who agreed to the trial would be&#xD;
      further screened with a baseline structured psychiatric evaluation in the third trimester of&#xD;
      the pregnancy to rule-out current depressive illness. If there was no evidence of depression&#xD;
      at the antepartum evaluation, patients delivering a liveborn singleton fetus at 34 0/7 weeks&#xD;
      or greater would be re-evaluated prior to discharge and, if scoring &lt;/= 12 on the Edinburgh&#xD;
      Postpartum Depression scale, would then be enrolled in the trial.&#xD;
&#xD;
      Patients would be assigned to either sertraline 50 mg daily or identical appearing placebo&#xD;
      for 12 weeks. Group allocation would be determined by restricted-randomization technique with&#xD;
      variable block length, with the sequence generated by someone not associated with participant&#xD;
      assignment. Assignment would be kept in sequentially numbered, opaque, sealed envelopes&#xD;
      (SNOSE) in the pharmacy, which would dispense the medication (or placebo). Patients would be&#xD;
      given a 30 day supply on the day of discharge, with refills provided by the study coordinator&#xD;
      (through the pharmacy)for 12 weeks and a four-day supply of 25 mg Sertraline or placebo at&#xD;
      the end of 12 weeks as a taper. Patients would also undergo follow-up blinded structured&#xD;
      psychiatric evaluations at 4 weeks, 8 weeks, and 12 weeks to assess for adverse reaction to&#xD;
      the assigned treatment agent, and for administration of questionnaires/evaluation to assess&#xD;
      for development of depression. Any patient with recognized clinical depression would&#xD;
      immediately be removed from further active participation in the study and referred to our&#xD;
      Cooper Psychiatry department or outside psychiatrist for ongoing evaluation and treatment.&#xD;
      Medication received (Sertraline or Placebo) would necessarily be revealed to Psych only for&#xD;
      purposes of guiding appropriate further treatment.&#xD;
&#xD;
      All women randomized would be analyzed according to group assignment (intent-to-treat).&#xD;
      Demographic information, including patient age, race/ethnicity, gravidity, parity,&#xD;
      gestational age at delivery, infant birth weight, as well as infant weights from standard&#xD;
      Pediatric visits (obtained verbally from the mother)would be recorded and compared using the&#xD;
      Student t-test for normally distributed continuous data, Mann-Whitney U for non-normative&#xD;
      continuous data, and the Chi Square test or Fisher Exact test for categorical data.&#xD;
&#xD;
      A sample size calculation was performed. Based on an anticipated rate of postpartum&#xD;
      depression (PPD) of 30% in the placebo group, we would need 62 subjects in each group to&#xD;
      detect a reduction in PPD to 10% in the sertraline group, with a power of .8 and a Type I&#xD;
      error of .05. Based on the 2200 deliveries occurring annually at Cooper University Hospital,&#xD;
      we anticipate that it would take 2-3 years to recruit 124 subjects into this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low recruitment, completion of funding cycle&#xD;
  </why_stopped>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Development of Postpartum Depression up to 12 Weeks Following Discharge From Hospital</measure>
    <time_frame>Discharge from hospital to 12 weeks postpartum</time_frame>
    <description>Patients met with single psychiatrist (co-investigator), blinded to group assignment, who evaluated the patient using Edinburgh Postpartum Depression Screen, Hamilton Depression Rating Scale, Global Assessment of Functioning Scale, and clinical assessment&#xD;
0 = No postpartum depression up to 12 weeks following discharge from hospital&#xD;
1 = Postpartum depression up to 12 weeks following discharge from hospital</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Reaction to Treatment Agent up to 12 Weeks Following Discharge From Hospital</measure>
    <time_frame>Discharge from hospital to 12 weeks postpartum</time_frame>
    <description>The Antidepressant Side-Effect Checklist (ASEC) was employed to detect any adverse reaction to treatment regimens</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reported Infant Weight at 4 Weeks Following Delivery</measure>
    <time_frame>4 weeks postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Perceived Infant Sleeping Difficulty at 4 Weeks Postpartum</measure>
    <time_frame>4 weeks postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Perceived Infant Feeding Difficulties 4 Weeks Postpartum</measure>
    <time_frame>4 weeks postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reported Infant Weight at 8 Weeks Following Delivery</measure>
    <time_frame>8 weeks postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reported Infant Weight at 12 Weeks Following Delivery</measure>
    <time_frame>12 weeks postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Perceived Infant Sleeping Difficulty at 8 Weeks Postpartum</measure>
    <time_frame>8 weeks postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Perceived Infant Sleeping Difficulty at 12 Weeks Postpartum</measure>
    <time_frame>12 weeks postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Perceived Infant Feeding Difficulties 8 Weeks Postpartum</measure>
    <time_frame>8 weeks postpartum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Perceived Infant Feeding Difficulties 12 Weeks Postpartum</measure>
    <time_frame>12 weeks postpartum</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Depression, Postpartum</condition>
  <arm_group>
    <arm_group_label>Sertraline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Identical appearing capsule daily containing color-matched cellulose only</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sertraline</intervention_name>
    <description>Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper</description>
    <arm_group_label>Sertraline</arm_group_label>
    <other_name>Zoloft</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Capsule containing cellulose powder of same color as experimental arm</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Cellulose powder</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Past history of depression or postpartum depression&#xD;
&#xD;
          2. Singleton gestation&#xD;
&#xD;
          3. Delivery &gt; 34 weeks gestation&#xD;
&#xD;
          4. No current clinical evidence of depression&#xD;
&#xD;
          5. Able to read and understand written English language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Multiple gestation&#xD;
&#xD;
          2. Delivery prior to 34 weeks&#xD;
&#xD;
          3. Delivery outside of Cooper University Hospital&#xD;
&#xD;
          4. Major fetal anomaly or fetal demise&#xD;
&#xD;
          5. Current use of antidepressants&#xD;
&#xD;
          6. Evidence of active depression at antepartum evaluation&#xD;
&#xD;
          7. Edinburgh Postpartum Depression scale of &gt;12 prior to discharge from the hospital&#xD;
&#xD;
          8. Maternal age &lt; 18 years&#xD;
&#xD;
          9. Infant in Neonatal Intensive Care Unit (NICU) at time of patient discharge from&#xD;
             hospital&#xD;
&#xD;
         10. Known or suspected allergy to Sertraline&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard L Fischer, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cooper Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cooper University Hospital</name>
      <address>
        <city>Camden</city>
        <state>New Jersey</state>
        <zip>08103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Chambers CD, Hernandez-Diaz S, Van Marter LJ, Werler MM, Louik C, Jones KL, Mitchell AA. Selective serotonin-reuptake inhibitors and risk of persistent pulmonary hypertension of the newborn. N Engl J Med. 2006 Feb 9;354(6):579-87. doi: 10.1056/NEJMoa052744.</citation>
    <PMID>16467545</PMID>
  </reference>
  <reference>
    <citation>Gold LH. Postpartum disorders in primary care: diagnosis and treatment. Prim Care. 2002 Mar;29(1):27-41, vi. doi: 10.1016/s0095-4543(03)00072-1.</citation>
    <PMID>11856657</PMID>
  </reference>
  <reference>
    <citation>ACOG Committee on Practice Bulletins--Obstetrics. ACOG Practice Bulletin: Clinical management guidelines for obstetrician-gynecologists number 92, April 2008 (replaces practice bulletin number 87, November 2007). Use of psychiatric medications during pregnancy and lactation. Obstet Gynecol. 2008 Apr;111(4):1001-20. doi: 10.1097/AOG.0b013e31816fd910. No abstract available.</citation>
    <PMID>18378767</PMID>
  </reference>
  <reference>
    <citation>Howard LM, Hoffbrand S, Henshaw C, Boath L, Bradley E. Antidepressant prevention of postnatal depression. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD004363. doi: 10.1002/14651858.CD004363.pub2.</citation>
    <PMID>15846711</PMID>
  </reference>
  <reference>
    <citation>Malm H, Klaukka T, Neuvonen PJ. Risks associated with selective serotonin reuptake inhibitors in pregnancy. Obstet Gynecol. 2005 Dec;106(6):1289-96. doi: 10.1097/01.AOG.0000187302.61812.53.</citation>
    <PMID>16319254</PMID>
  </reference>
  <reference>
    <citation>Moses-Kolko EL, Bogen D, Perel J, Bregar A, Uhl K, Levin B, Wisner KL. Neonatal signs after late in utero exposure to serotonin reuptake inhibitors: literature review and implications for clinical applications. JAMA. 2005 May 18;293(19):2372-83. doi: 10.1001/jama.293.19.2372.</citation>
    <PMID>15900008</PMID>
  </reference>
  <reference>
    <citation>Payne JL. Antidepressant use in the postpartum period: practical considerations. Am J Psychiatry. 2007 Sep;164(9):1329-32. doi: 10.1176/appi.ajp.2007.07030390. No abstract available.</citation>
    <PMID>17728416</PMID>
  </reference>
  <reference>
    <citation>Pearlstein T, Howard M, Salisbury A, Zlotnick C. Postpartum depression. Am J Obstet Gynecol. 2009 Apr;200(4):357-64. doi: 10.1016/j.ajog.2008.11.033.</citation>
    <PMID>19318144</PMID>
  </reference>
  <reference>
    <citation>Safety of SSRIs in Pregnancy. Med Lett Drugs Ther. 2008 Nov 17;50(1299):89-91. No abstract available.</citation>
    <PMID>19008787</PMID>
  </reference>
  <reference>
    <citation>Sanz EJ, De-las-Cuevas C, Kiuru A, Bate A, Edwards R. Selective serotonin reuptake inhibitors in pregnant women and neonatal withdrawal syndrome: a database analysis. Lancet. 2005 Feb 5-11;365(9458):482-7. doi: 10.1016/S0140-6736(05)17865-9.</citation>
    <PMID>15705457</PMID>
  </reference>
  <reference>
    <citation>Wisner KL, Perel JM, Peindl KS, Hanusa BH, Piontek CM, Findling RL. Prevention of postpartum depression: a pilot randomized clinical trial. Am J Psychiatry. 2004 Jul;161(7):1290-2. doi: 10.1176/appi.ajp.161.7.1290.</citation>
    <PMID>15229064</PMID>
  </reference>
  <reference>
    <citation>Wisner KL, Perel JM, Peindl KS, Hanusa BH, Findling RL, Rapport D. Prevention of recurrent postpartum depression: a randomized clinical trial. J Clin Psychiatry. 2001 Feb;62(2):82-6. doi: 10.4088/jcp.v62n0202.</citation>
    <PMID>11247106</PMID>
  </reference>
  <reference>
    <citation>Yonkers KA, Wisner KL, Stewart DE, Oberlander TF, Dell DL, Stotland N, Ramin S, Chaudron L, Lockwood C. The management of depression during pregnancy: a report from the American Psychiatric Association and the American College of Obstetricians and Gynecologists. Obstet Gynecol. 2009 Sep;114(3):703-713. doi: 10.1097/AOG.0b013e3181ba0632.</citation>
    <PMID>19701065</PMID>
  </reference>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <results_first_submitted>February 24, 2017</results_first_submitted>
  <results_first_submitted_qc>February 24, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 10, 2017</results_first_posted>
  <last_update_submitted>February 27, 2018</last_update_submitted>
  <last_update_submitted_qc>February 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Cooper Health System</investigator_affiliation>
    <investigator_full_name>Richard Fischer MD</investigator_full_name>
    <investigator_title>Professor, Department of OB/GYN, Cooper Medical School of Rowan University</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression, Postpartum</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sertraline</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Only aggregate data to be reported</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Sertraline</title>
          <description>Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper&#xD;
Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Identical appearing capsule daily containing color-matched cellulose only&#xD;
Placebo: Capsule containing cellulose powder of same color as experimental arm</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Sertraline</title>
          <description>Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper&#xD;
Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Identical appearing capsule daily containing color-matched cellulose only&#xD;
Placebo: Capsule containing cellulose powder of same color as experimental arm</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1"/>
            <count group_id="B2" value="1"/>
            <count group_id="B3" value="2"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33" lower_limit="33" upper_limit="33"/>
                    <measurement group_id="B2" value="30" lower_limit="30" upper_limit="30"/>
                    <measurement group_id="B3" value="31.5" lower_limit="30" upper_limit="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Development of Postpartum Depression up to 12 Weeks Following Discharge From Hospital</title>
        <description>Patients met with single psychiatrist (co-investigator), blinded to group assignment, who evaluated the patient using Edinburgh Postpartum Depression Screen, Hamilton Depression Rating Scale, Global Assessment of Functioning Scale, and clinical assessment&#xD;
0 = No postpartum depression up to 12 weeks following discharge from hospital&#xD;
1 = Postpartum depression up to 12 weeks following discharge from hospital</description>
        <time_frame>Discharge from hospital to 12 weeks postpartum</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sertraline</title>
            <description>Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper&#xD;
Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Identical appearing capsule daily containing color-matched cellulose only&#xD;
Placebo: Capsule containing cellulose powder of same color as experimental arm</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Development of Postpartum Depression up to 12 Weeks Following Discharge From Hospital</title>
          <description>Patients met with single psychiatrist (co-investigator), blinded to group assignment, who evaluated the patient using Edinburgh Postpartum Depression Screen, Hamilton Depression Rating Scale, Global Assessment of Functioning Scale, and clinical assessment&#xD;
0 = No postpartum depression up to 12 weeks following discharge from hospital&#xD;
1 = Postpartum depression up to 12 weeks following discharge from hospital</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Reaction to Treatment Agent up to 12 Weeks Following Discharge From Hospital</title>
        <description>The Antidepressant Side-Effect Checklist (ASEC) was employed to detect any adverse reaction to treatment regimens</description>
        <time_frame>Discharge from hospital to 12 weeks postpartum</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sertraline</title>
            <description>Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Identical appearing capsule daily containing color-matched cellulose only</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Reaction to Treatment Agent up to 12 Weeks Following Discharge From Hospital</title>
          <description>The Antidepressant Side-Effect Checklist (ASEC) was employed to detect any adverse reaction to treatment regimens</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Reported Infant Weight at 4 Weeks Following Delivery</title>
        <time_frame>4 weeks postpartum</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sertraline</title>
            <description>Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Identical appearing capsule daily containing color-matched cellulose only</description>
          </group>
        </group_list>
        <measure>
          <title>Reported Infant Weight at 4 Weeks Following Delivery</title>
          <units>Grams</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3033" lower_limit="3033" upper_limit="3033"/>
                    <measurement group_id="O2" value="2750" lower_limit="2750" upper_limit="2750"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Perceived Infant Sleeping Difficulty at 4 Weeks Postpartum</title>
        <time_frame>4 weeks postpartum</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sertraline</title>
            <description>Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Identical appearing capsule daily containing color-matched cellulose only</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Perceived Infant Sleeping Difficulty at 4 Weeks Postpartum</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Perceived Infant Feeding Difficulties 4 Weeks Postpartum</title>
        <time_frame>4 weeks postpartum</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sertraline</title>
            <description>Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Identical appearing capsule daily containing color-matched cellulose only</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Perceived Infant Feeding Difficulties 4 Weeks Postpartum</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Reported Infant Weight at 8 Weeks Following Delivery</title>
        <time_frame>8 weeks postpartum</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sertraline</title>
            <description>Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Identical appearing capsule daily containing color-matched cellulose only</description>
          </group>
        </group_list>
        <measure>
          <title>Reported Infant Weight at 8 Weeks Following Delivery</title>
          <units>Grams</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5301" lower_limit="5301" upper_limit="5301"/>
                    <measurement group_id="O2" value="3685" lower_limit="3685" upper_limit="3685"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Reported Infant Weight at 12 Weeks Following Delivery</title>
        <time_frame>12 weeks postpartum</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sertraline</title>
            <description>Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Identical appearing capsule daily containing color-matched cellulose only</description>
          </group>
        </group_list>
        <measure>
          <title>Reported Infant Weight at 12 Weeks Following Delivery</title>
          <units>Grams</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5301" lower_limit="5301" upper_limit="5301"/>
                    <measurement group_id="O2" value="4734" lower_limit="4734" upper_limit="4734"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Perceived Infant Sleeping Difficulty at 8 Weeks Postpartum</title>
        <time_frame>8 weeks postpartum</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sertraline</title>
            <description>Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Identical appearing capsule daily containing color-matched cellulose only</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Perceived Infant Sleeping Difficulty at 8 Weeks Postpartum</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Perceived Infant Sleeping Difficulty at 12 Weeks Postpartum</title>
        <time_frame>12 weeks postpartum</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sertraline</title>
            <description>Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Identical appearing capsule daily containing color-matched cellulose only</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Perceived Infant Sleeping Difficulty at 12 Weeks Postpartum</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Perceived Infant Feeding Difficulties 8 Weeks Postpartum</title>
        <time_frame>8 weeks postpartum</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sertraline</title>
            <description>Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Identical appearing capsule daily containing color-matched cellulose only</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Perceived Infant Feeding Difficulties 8 Weeks Postpartum</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Perceived Infant Feeding Difficulties 12 Weeks Postpartum</title>
        <time_frame>12 weeks postpartum</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sertraline</title>
            <description>Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Identical appearing capsule daily containing color-matched cellulose only</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Perceived Infant Feeding Difficulties 12 Weeks Postpartum</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Sertraline</title>
          <description>Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper&#xD;
Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Identical appearing capsule daily containing color-matched cellulose only&#xD;
Placebo: Capsule containing cellulose powder of same color as experimental arm</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Richard L Fischer</name_or_title>
      <organization>Cooper University Health System</organization>
      <phone>856-342-2491</phone>
      <email>fischer-richard@cooperhealth.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02235064
org study id: CUH IRB#: 14-078
nct id: NCT02235064
lead sponsor: 
has dmc: No
The purpose of this project is to assess the effectiveness of preventative antidepressants
      immediately following delivery on postpartum depression rates in women at high risk due to
      prior history of depression or postpartum depression.
Eligible women for our study would be identified antepartum from our three obstetrical groups
      delivering at Cooper University Hospital: Cooper Faculty Group, Women's Care Center, and
      CamCare. Potentially eligible women would be referred to the study coordinator or principal
      investigator to discuss the nature of the study. Those women who agreed to the trial would be
      further screened with a baseline structured psychiatric evaluation in the third trimester of
      the pregnancy to rule-out current depressive illness. If there was no evidence of depression
      at the antepartum evaluation, patients delivering a liveborn singleton fetus at 34 0/7 weeks
      or greater would be re-evaluated prior to discharge and, if scoring </= 12 on the Edinburgh
      Postpartum Depression scale, would then be enrolled in the trial.

      Patients would be assigned to either sertraline 50 mg daily or identical appearing placebo
      for 12 weeks. Group allocation would be determined by restricted-randomization technique with
      variable block length, with the sequence generated by someone not associated with participant
      assignment. Assignment would be kept in sequentially numbered, opaque, sealed envelopes
      (SNOSE) in the pharmacy, which would dispense the medication (or placebo). Patients would be
      given a 30 day supply on the day of discharge, with refills provided by the study coordinator
      (through the pharmacy)for 12 weeks and a four-day supply of 25 mg Sertraline or placebo at
      the end of 12 weeks as a taper. Patients would also undergo follow-up blinded structured
      psychiatric evaluations at 4 weeks, 8 weeks, and 12 weeks to assess for adverse reaction to
      the assigned treatment agent, and for administration of questionnaires/evaluation to assess
      for development of depression. Any patient with recognized clinical depression would
      immediately be removed from further active participation in the study and referred to our
      Cooper Psychiatry department or outside psychiatrist for ongoing evaluation and treatment.
      Medication received (Sertraline or Placebo) would necessarily be revealed to Psych only for
      purposes of guiding appropriate further treatment.

      All women randomized would be analyzed according to group assignment (intent-to-treat).
      Demographic information, including patient age, race/ethnicity, gravidity, parity,
      gestational age at delivery, infant birth weight, as well as infant weights from standard
      Pediatric visits (obtained verbally from the mother)would be recorded and compared using the
      Student t-test for normally distributed continuous data, Mann-Whitney U for non-normative
      continuous data, and the Chi Square test or Fisher Exact test for categorical data.

      A sample size calculation was performed. Based on an anticipated rate of postpartum
      depression (PPD) of 30% in the placebo group, we would need 62 subjects in each group to
      detect a reduction in PPD to 10% in the sertraline group, with a power of .8 and a Type I
      error of .05. Based on the 2200 deliveries occurring annually at Cooper University Hospital,
      we anticipate that it would take 2-3 years to recruit 124 subjects into this study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants With Development of Postpartum Depression up to 12 Weeks Following Discharge From Hospital
time frame: Discharge from hospital to 12 weeks postpartum
description: Patients met with single psychiatrist (co-investigator), blinded to group assignment, who evaluated the patient using Edinburgh Postpartum Depression Screen, Hamilton Depression Rating Scale, Global Assessment of Functioning Scale, and clinical assessment
0 = No postpartum depression up to 12 weeks following discharge from hospital
1 = Postpartum depression up to 12 weeks following discharge from hospital
measure: Number of Participants With Adverse Reaction to Treatment Agent up to 12 Weeks Following Discharge From Hospital
time frame: Discharge from hospital to 12 weeks postpartum
description: The Antidepressant Side-Effect Checklist (ASEC) was employed to detect any adverse reaction to treatment regimens
measure: Reported Infant Weight at 4 Weeks Following Delivery
time frame: 4 weeks postpartum
measure: Number of Participants With Perceived Infant Sleeping Difficulty at 4 Weeks Postpartum
time frame: 4 weeks postpartum
measure: Number of Participants With Perceived Infant Feeding Difficulties 4 Weeks Postpartum
time frame: 4 weeks postpartum
measure: Reported Infant Weight at 8 Weeks Following Delivery
time frame: 8 weeks postpartum
measure: Reported Infant Weight at 12 Weeks Following Delivery
time frame: 12 weeks postpartum
measure: Number of Participants With Perceived Infant Sleeping Difficulty at 8 Weeks Postpartum
time frame: 8 weeks postpartum
measure: Number of Participants With Perceived Infant Sleeping Difficulty at 12 Weeks Postpartum
time frame: 12 weeks postpartum
measure: Number of Participants With Perceived Infant Feeding Difficulties 8 Weeks Postpartum
time frame: 8 weeks postpartum
measure: Number of Participants With Perceived Infant Feeding Difficulties 12 Weeks Postpartum
time frame: 12 weeks postpartum
arm group label: Sertraline
arm group type: Experimental
description: Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper
arm group label: Placebo
arm group type: Placebo Comparator
description: Identical appearing capsule daily containing color-matched cellulose only
intervention type: Drug
intervention name: Sertraline
description: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper
arm group label: Sertraline
other name: Zoloft
intervention type: Drug
intervention name: Placebo
description: Capsule containing cellulose powder of same color as experimental arm
arm group label: Placebo
other name: Cellulose powder
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Richard L Fischer, M.D.
role: Principal Investigator
affiliation: Cooper Health System
facility: 
country: United States
citation: Chambers CD, Hernandez-Diaz S, Van Marter LJ, Werler MM, Louik C, Jones KL, Mitchell AA. Selective serotonin-reuptake inhibitors and risk of persistent pulmonary hypertension of the newborn. N Engl J Med. 2006 Feb 9;354(6):579-87. doi: 10.1056/NEJMoa052744.
PMID: 16467545
citation: Gold LH. Postpartum disorders in primary care: diagnosis and treatment. Prim Care. 2002 Mar;29(1):27-41, vi. doi: 10.1016/s0095-4543(03)00072-1.
PMID: 11856657
citation: ACOG Committee on Practice Bulletins--Obstetrics. ACOG Practice Bulletin: Clinical management guidelines for obstetrician-gynecologists number 92, April 2008 (replaces practice bulletin number 87, November 2007). Use of psychiatric medications during pregnancy and lactation. Obstet Gynecol. 2008 Apr;111(4):1001-20. doi: 10.1097/AOG.0b013e31816fd910. No abstract available.
PMID: 18378767
citation: Howard LM, Hoffbrand S, Henshaw C, Boath L, Bradley E. Antidepressant prevention of postnatal depression. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD004363. doi: 10.1002/14651858.CD004363.pub2.
PMID: 15846711
citation: Malm H, Klaukka T, Neuvonen PJ. Risks associated with selective serotonin reuptake inhibitors in pregnancy. Obstet Gynecol. 2005 Dec;106(6):1289-96. doi: 10.1097/01.AOG.0000187302.61812.53.
PMID: 16319254
citation: Moses-Kolko EL, Bogen D, Perel J, Bregar A, Uhl K, Levin B, Wisner KL. Neonatal signs after late in utero exposure to serotonin reuptake inhibitors: literature review and implications for clinical applications. JAMA. 2005 May 18;293(19):2372-83. doi: 10.1001/jama.293.19.2372.
PMID: 15900008
citation: Payne JL. Antidepressant use in the postpartum period: practical considerations. Am J Psychiatry. 2007 Sep;164(9):1329-32. doi: 10.1176/appi.ajp.2007.07030390. No abstract available.
PMID: 17728416
citation: Pearlstein T, Howard M, Salisbury A, Zlotnick C. Postpartum depression. Am J Obstet Gynecol. 2009 Apr;200(4):357-64. doi: 10.1016/j.ajog.2008.11.033.
PMID: 19318144
citation: Safety of SSRIs in Pregnancy. Med Lett Drugs Ther. 2008 Nov 17;50(1299):89-91. No abstract available.
PMID: 19008787
citation: Sanz EJ, De-las-Cuevas C, Kiuru A, Bate A, Edwards R. Selective serotonin reuptake inhibitors in pregnant women and neonatal withdrawal syndrome: a database analysis. Lancet. 2005 Feb 5-11;365(9458):482-7. doi: 10.1016/S0140-6736(05)17865-9.
PMID: 15705457
citation: Wisner KL, Perel JM, Peindl KS, Hanusa BH, Piontek CM, Findling RL. Prevention of postpartum depression: a pilot randomized clinical trial. Am J Psychiatry. 2004 Jul;161(7):1290-2. doi: 10.1176/appi.ajp.161.7.1290.
PMID: 15229064
citation: Wisner KL, Perel JM, Peindl KS, Hanusa BH, Findling RL, Rapport D. Prevention of recurrent postpartum depression: a randomized clinical trial. J Clin Psychiatry. 2001 Feb;62(2):82-6. doi: 10.4088/jcp.v62n0202.
PMID: 11247106
citation: Yonkers KA, Wisner KL, Stewart DE, Oberlander TF, Dell DL, Stotland N, Ramin S, Chaudron L, Lockwood C. The management of depression during pregnancy: a report from the American Psychiatric Association and the American College of Obstetricians and Gynecologists. Obstet Gynecol. 2009 Sep;114(3):703-713. doi: 10.1097/AOG.0b013e3181ba0632.
PMID: 19701065
responsible party type: Principal Investigator
investigator affiliation: The Cooper Health System
investigator full name: Richard Fischer MD
investigator title: Professor, Department of OB/GYN, Cooper Medical School of Rowan University
mesh term: Depression, Postpartum
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Sertraline
sharing ipd: No
ipd description: Only aggregate data to be reported
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 