<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/NCT02191423</url>
  </required_header>
  <id_info>
    <org_study_id>TASMC-14-MB-161-CTIL</org_study_id>
    <nct_id>NCT02191423</nct_id>
  </id_info>
  <brief_title>Oxytocin and Dyadic Psychotherapy in the Treatment of Post Partum Depression</brief_title>
  <official_title>The Effect of Oxytocin on Brain Attachment and Empathy Networks, and the Association Between the Brain Response and Treatment Outcome of Brief Dyadic Psychotherapy - in Women Suffering From Postpartum Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel-Aviv Sourasky Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tel-Aviv Sourasky Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rationale and Hypotheses of the Current Research: the investigators speculate that mothers&#xD;
      suffering from PPD exhibit high levels of depression and low levels of OXT, hence&#xD;
      experiencing the interaction with their child as less rewarding, which in turn promote&#xD;
      further depressive symptoms and interfere with child development. While dyadic psychotherapy&#xD;
      has been studied in this context, it is unknown which depressed women will respond to this&#xD;
      type of therapy, and whether such a response is mediated by the pro-bonding effect of&#xD;
      oxytocin.&#xD;
&#xD;
      The aim of this study is three-fold:&#xD;
&#xD;
        1. To study the effect of the administration of a single dose (24IU) of oxytocin on&#xD;
           cerebral circuit processing and connectivity of empathy and attachment.&#xD;
&#xD;
        2. To examine whether the clinical response of mothers suffering from postpartum depression&#xD;
           to short term dyadic psychotherapy (based on improved mother-child interactions) can be&#xD;
           predicted by a unique brain response pattern to oxytocin.&#xD;
&#xD;
        3. To assess the relationship between levels of oxytocin in mother and baby and the&#xD;
           effectiveness of psychological dyadic treatment on mothers suffering from postpartum&#xD;
           depression.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2015</start_date>
  <primary_completion_date type="Anticipated">June 2016</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>Diagnostic</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of the administration of oxytocin on cerebral circuit processing</measure>
    <time_frame>Two functional brain scans one week after admission to the study (week2)</time_frame>
    <description>1. This paradigm assesses empathic responses to images of individuals experiencing sad, anxious and happy events. Images are preceded by social context (i.e. &quot;this person just won the lottery&quot;). Control condition presents participants with images of people performing everyday actions.&#xD;
3.we generated 15 short screenplays containing triggers for both types of empathy. Each of the screenplays depicts a situation in which the characters pose a negatively-valenced bodily state (e.g. crying, itching, choking), which we expect to elicit embodied simulation in the viewer.&#xD;
2. This paradigm examines maternal FMRI responses to infant related video vignettes. Stimuli include movies of mothers' own infant vs strange infant during solitary play and mother-infant interaction.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interactional measures-CIB</measure>
    <time_frame>pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year</time_frame>
    <description>The Coding Interactive Behavior Manual (CIB) (Feldman 1998), a well-validated system for coding dyadic interactions, by individuals blind to the study group that the participant is a member in. The following behaviors will be compute: Parents behavior; Child behavior; Dyadic behavior; Lead-Lag Relationship</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interactional measures-Noldus</measure>
    <time_frame>pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year</time_frame>
    <description>Micro-analytic coding of synchrony- on a computerized system (Noldus, The Vaggenigen, Netherlands), coded on a computerized system that allows for .01-second exactness. Consistent with previous research on parent-infant synchrony (Feldman and Eidelman, 2004, 2007). Four non-verbal categories of parenting behavior and four non-verbal categories of infant behavior will be coded and each category will include a set of mutually exclusive codes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maternal depression symptoms measures- BDI</measure>
    <time_frame>mothers will complete the BDI once a week during the 8-week trial, as well as in the pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year</time_frame>
    <description>Beck Depression Inventory- BDI (Beck, Ward, Mendelson, Mock, and Erbaugh, 1961) is designed to assess the severity of depression while referring to affective, cognitive, physical and behavioral aspects.&#xD;
The BDI consists of 21 items, divided in to 3 factors: sadness / negative self perception, psycho-motor deceleration and somatic depression. Every item consists of 4 sentences for self-esteem, in a scale of 0-3, according to the degree of depression. Scores of 9 or above indicate elevated depressive symptoms and a risk for MDD (Kendall, Hollon, Beck, et al 1987). The BDI is a widely used inventory which was found to be well validated and highly coefficient (for a meta analysis see: Beck, Steer, &amp; Garbin, 1988).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal depression symptoms measures - EPDS</measure>
    <time_frame>pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year</time_frame>
    <description>Edinburgh Postnatal Depression Scale- EPDS, (Cox, Holden, Sagovsky, 1987) is designed in order to screen for postnatal depression in the community. The EPDS is a brief (10-item) scale. The questions focus on the psychological rather than the somatic aspects of depression and explore 2 distinct domains of negative affect: depressive symptoms (7 items) and anxiety (3 items) (Kabir, Sheeder and Kelly, 2008). Subjects respond to items on a 4 point Likert scale (of 0-3), resulting in a total score range between 0 and 30. Scores of 10 or above indicate elevated depressive symptoms and a risk for PPD (Cox, Holden, Sagovsky, 1987). The EPDS is a widely used scale which was found to be well validated and highly coefficient (Cox, Holden, Sagovsky, 1987; Kabir, Sheeder and Kelly ,2008; Murray &amp; Carothers, 1990).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal anxiety measures-STAI</measure>
    <time_frame>mothers will complete the STAI once a week during the 8-week trial, as well as in the pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year</time_frame>
    <description>State- Trait Anxiety Inventory- STAI (Spielberger, Gorsuch, and Lushene, 1970) assesses levels of situational and trait anxiety. The STAI contains 40 declarations, 20 of which refer to situational anxiety and 20 of which refer to trait anxiety. Subjects will indicate on a scale of 1-4 (1=not it all, 4=to a large extent) to what extent they think the declaration is accurate in their case. Trait anxiety scores of above 43 are considered a risk indicator for anxiety disorders (Spielberger, et al., 1970). The STAI is a widely used inventory which was found to be well validated and highly coefficient (Anastasi, 1988).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physiological measures-Salivary OXT</measure>
    <time_frame>both mothers and infants will give six saliva samples; once a other week during the 8-week trial, as well as in the pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year</time_frame>
    <description>Salivary OXT -in order to examine OXT and reactivity curve in PPD women and their infants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal thought and action measures</measure>
    <time_frame>mothers will complete the YIPTA twice; in the pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year</time_frame>
    <description>Maternal thoughts and actions will be assessed with the Yale Inventory of Parental Thoughts and Actions (YIPTA) - a semi-structured interview which provides a validated measure of parental worries, comprising a range of anxious intrusive thoughts and harm avoidant behaviors (AITHAR; Feldman, Weller, Leckman, Kuint, &amp; Eidelman, 1999; Leckman et al., 2004; Leckman et al., 1999; Mayes, Swain, Feldman, &amp; Leckman, 2008). Such thoughts and behaviors include concerns about the baby's physical environment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Postpartum Depression</condition>
  <arm_group>
    <arm_group_label>postpartum depression</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women suffering from postpartum depression, assessed by fMRI and then treated by dyadic psychotherapy&#xD;
All participants will undergo two functional brain scans at the Tel Aviv Medical Center. The two scans will take place one week apart, one scan will include administration of oxytocin (24IU) and the other will include the use of placebo (the order in which the two different treatments is applied will be random).&#xD;
All women in this group participate in 8-weeks of dyadic psychotherapy (DP) at the outpatient Psychiatric Department, Tel-Aviv Medical Center.&#xD;
A final end-of-study clinical evaluation, will be conducted at the end of 8 weeks. The evaluation will include a psychiatric evaluation, the MADRS, and a physical examination, the mother-infant interaction will be videotaped, and the YIPTA, BDI, EPDS &amp; STAI will be administered. Salivary OXT samples will be collected from the mother and from the infant and infants will undergo a developmental assessment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>normal controls</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Normal control women not suffering from postpartum depression assessed by fMRI&#xD;
All participants will undergo two functional brain scans at the Tel Aviv Medical Center. The two scans will take place one week apart, one scan will include administration of oxytocin (24IU) and the other will include the use of placebo (the order in which the two different treatments is applied will be random).&#xD;
A final end-of-study clinical evaluation, will be conducted at the end of 8 weeks. The evaluation will include a psychiatric evaluation, the MADRS, and a physical examination, the mother-infant interaction will be videotaped, and the YIPTA, BDI, EPDS &amp; STAI will be administered. Salivary OXT samples will be collected from the mother and from the infant and infants will undergo a developmental assessment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin</intervention_name>
    <description>administered pre-fMRI assessment</description>
    <arm_group_label>normal controls</arm_group_label>
    <arm_group_label>postpartum depression</arm_group_label>
    <other_name>Syntocinon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>administered pre-fMRI assessment</description>
    <arm_group_label>normal controls</arm_group_label>
    <arm_group_label>postpartum depression</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dyadic psychotherapy</intervention_name>
    <arm_group_label>postpartum depression</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women of all ages who are 3 to 8 months post-partum.&#xD;
&#xD;
          -  Women who have completed a minimum of 12 years of education.&#xD;
&#xD;
          -  Women who are willing and able to provide informed consent for their participation and&#xD;
             after the study has been explained. Infant participation will be allowed after consent&#xD;
             has been obtained from mothers.&#xD;
&#xD;
          -  Current DSM-IV-TR diagnosis of PPD disorder as confirmed by SCID (administered as part&#xD;
             of the study of protocol number PPD1, proposed to the Helsinki committee on June&#xD;
             2014).&#xD;
&#xD;
          -  Symptoms: BDI total score &gt;9, EPDS total score &gt;10&#xD;
&#xD;
          -  Treatment with antidepressants will be allowed provided that patients have been on the&#xD;
             medication for at least 4 weeks prior to entry into the pre-treatment assessment phase&#xD;
             of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwilling or unable, in the opinion of the investigator, to comply with study&#xD;
             instructions.&#xD;
&#xD;
          -  Pregnant women.&#xD;
&#xD;
          -  Clinically significant medical disease (malignancy, poorly controlled diabetes, active&#xD;
             ischemic cardiac disease, or cardiomyopathy, serious pulmonary disease, kidney&#xD;
             disease, impaired liver functioning).&#xD;
&#xD;
          -  Women with significant risk of committing suicide or harming others in the opinion of&#xD;
             the psychiatrist.&#xD;
&#xD;
          -  Women with a current DSM-IV-TR substance or alcohol abuse. However, patients with a&#xD;
             history of and/or current recreational use of cannabinoids or alcohol, and/or patients&#xD;
             who smoke cigarettes can be included.&#xD;
&#xD;
          -  Women who suffers from depression due to physical condition.&#xD;
&#xD;
          -  Women who suffers from severe major depression (MADRAS&gt;30)&#xD;
&#xD;
          -  Women who suffers from chronic depression (over 6 months)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Miki Bloch, Prof.</last_name>
    <phone>972-3-6974707</phone>
    <email>mikib@tlvmc.gov.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ruth Feldman, PhD</last_name>
    <phone>972-3-5317943</phone>
    <email>ortalsh@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Tel-Aviv Sourasky Medical Center</name>
      <address>
        <city>Tel-Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
    <investigator>
      <last_name>Miki Bloch, Prof.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>July 13, 2014</last_update_submitted>
  <last_update_submitted_qc>July 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>postpartum Depression</keyword>
  <keyword>Diadic psychotherapy</keyword>
  <keyword>Oxytocin</keyword>
  <keyword>fMRI</keyword>
  <keyword>attachment</keyword>
  <keyword>empathy</keyword>
  <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>Oxytocin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02191423
org study id: TASMC-14-MB-161-CTIL
nct id: NCT02191423
lead sponsor: 
has dmc: Yes
Rationale and Hypotheses of the Current Research: the investigators speculate that mothers
      suffering from PPD exhibit high levels of depression and low levels of OXT, hence
      experiencing the interaction with their child as less rewarding, which in turn promote
      further depressive symptoms and interfere with child development. While dyadic psychotherapy
      has been studied in this context, it is unknown which depressed women will respond to this
      type of therapy, and whether such a response is mediated by the pro-bonding effect of
      oxytocin.

      The aim of this study is three-fold:

        1. To study the effect of the administration of a single dose (24IU) of oxytocin on
           cerebral circuit processing and connectivity of empathy and attachment.

        2. To examine whether the clinical response of mothers suffering from postpartum depression
           to short term dyadic psychotherapy (based on improved mother-child interactions) can be
           predicted by a unique brain response pattern to oxytocin.

        3. To assess the relationship between levels of oxytocin in mother and baby and the
           effectiveness of psychological dyadic treatment on mothers suffering from postpartum
           depression.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Effect of the administration of oxytocin on cerebral circuit processing
time frame: Two functional brain scans one week after admission to the study (week2)
description: 1. This paradigm assesses empathic responses to images of individuals experiencing sad, anxious and happy events. Images are preceded by social context (i.e. "this person just won the lottery"). Control condition presents participants with images of people performing everyday actions.
3.we generated 15 short screenplays containing triggers for both types of empathy. Each of the screenplays depicts a situation in which the characters pose a negatively-valenced bodily state (e.g. crying, itching, choking), which we expect to elicit embodied simulation in the viewer.
2. This paradigm examines maternal FMRI responses to infant related video vignettes. Stimuli include movies of mothers' own infant vs strange infant during solitary play and mother-infant interaction.
measure: Interactional measures-CIB
time frame: pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
description: The Coding Interactive Behavior Manual (CIB) (Feldman 1998), a well-validated system for coding dyadic interactions, by individuals blind to the study group that the participant is a member in. The following behaviors will be compute: Parents behavior; Child behavior; Dyadic behavior; Lead-Lag Relationship
measure: Interactional measures-Noldus
time frame: pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
description: Micro-analytic coding of synchrony- on a computerized system (Noldus, The Vaggenigen, Netherlands), coded on a computerized system that allows for .01-second exactness. Consistent with previous research on parent-infant synchrony (Feldman and Eidelman, 2004, 2007). Four non-verbal categories of parenting behavior and four non-verbal categories of infant behavior will be coded and each category will include a set of mutually exclusive codes.
measure: Maternal depression symptoms measures- BDI
time frame: mothers will complete the BDI once a week during the 8-week trial, as well as in the pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
description: Beck Depression Inventory- BDI (Beck, Ward, Mendelson, Mock, and Erbaugh, 1961) is designed to assess the severity of depression while referring to affective, cognitive, physical and behavioral aspects.
The BDI consists of 21 items, divided in to 3 factors: sadness / negative self perception, psycho-motor deceleration and somatic depression. Every item consists of 4 sentences for self-esteem, in a scale of 0-3, according to the degree of depression. Scores of 9 or above indicate elevated depressive symptoms and a risk for MDD (Kendall, Hollon, Beck, et al 1987). The BDI is a widely used inventory which was found to be well validated and highly coefficient (for a meta analysis see: Beck, Steer, & Garbin, 1988).
measure: Maternal depression symptoms measures - EPDS
time frame: pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
description: Edinburgh Postnatal Depression Scale- EPDS, (Cox, Holden, Sagovsky, 1987) is designed in order to screen for postnatal depression in the community. The EPDS is a brief (10-item) scale. The questions focus on the psychological rather than the somatic aspects of depression and explore 2 distinct domains of negative affect: depressive symptoms (7 items) and anxiety (3 items) (Kabir, Sheeder and Kelly, 2008). Subjects respond to items on a 4 point Likert scale (of 0-3), resulting in a total score range between 0 and 30. Scores of 10 or above indicate elevated depressive symptoms and a risk for PPD (Cox, Holden, Sagovsky, 1987). The EPDS is a widely used scale which was found to be well validated and highly coefficient (Cox, Holden, Sagovsky, 1987; Kabir, Sheeder and Kelly ,2008; Murray & Carothers, 1990).
measure: Maternal anxiety measures-STAI
time frame: mothers will complete the STAI once a week during the 8-week trial, as well as in the pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
description: State- Trait Anxiety Inventory- STAI (Spielberger, Gorsuch, and Lushene, 1970) assesses levels of situational and trait anxiety. The STAI contains 40 declarations, 20 of which refer to situational anxiety and 20 of which refer to trait anxiety. Subjects will indicate on a scale of 1-4 (1=not it all, 4=to a large extent) to what extent they think the declaration is accurate in their case. Trait anxiety scores of above 43 are considered a risk indicator for anxiety disorders (Spielberger, et al., 1970). The STAI is a widely used inventory which was found to be well validated and highly coefficient (Anastasi, 1988).
measure: Physiological measures-Salivary OXT
time frame: both mothers and infants will give six saliva samples; once a other week during the 8-week trial, as well as in the pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
description: Salivary OXT -in order to examine OXT and reactivity curve in PPD women and their infants
measure: Maternal thought and action measures
time frame: mothers will complete the YIPTA twice; in the pre (baseline at week 1) and post (week 11) experimental trial assessments. Data will be presented up to 1 year
description: Maternal thoughts and actions will be assessed with the Yale Inventory of Parental Thoughts and Actions (YIPTA) - a semi-structured interview which provides a validated measure of parental worries, comprising a range of anxious intrusive thoughts and harm avoidant behaviors (AITHAR; Feldman, Weller, Leckman, Kuint, & Eidelman, 1999; Leckman et al., 2004; Leckman et al., 1999; Mayes, Swain, Feldman, & Leckman, 2008). Such thoughts and behaviors include concerns about the baby's physical environment.
arm group label: postpartum depression
arm group type: Experimental
description: Women suffering from postpartum depression, assessed by fMRI and then treated by dyadic psychotherapy
All participants will undergo two functional brain scans at the Tel Aviv Medical Center. The two scans will take place one week apart, one scan will include administration of oxytocin (24IU) and the other will include the use of placebo (the order in which the two different treatments is applied will be random).
All women in this group participate in 8-weeks of dyadic psychotherapy (DP) at the outpatient Psychiatric Department, Tel-Aviv Medical Center.
A final end-of-study clinical evaluation, will be conducted at the end of 8 weeks. The evaluation will include a psychiatric evaluation, the MADRS, and a physical examination, the mother-infant interaction will be videotaped, and the YIPTA, BDI, EPDS & STAI will be administered. Salivary OXT samples will be collected from the mother and from the infant and infants will undergo a developmental assessment.
arm group label: normal controls
arm group type: Other
description: Normal control women not suffering from postpartum depression assessed by fMRI
All participants will undergo two functional brain scans at the Tel Aviv Medical Center. The two scans will take place one week apart, one scan will include administration of oxytocin (24IU) and the other will include the use of placebo (the order in which the two different treatments is applied will be random).
A final end-of-study clinical evaluation, will be conducted at the end of 8 weeks. The evaluation will include a psychiatric evaluation, the MADRS, and a physical examination, the mother-infant interaction will be videotaped, and the YIPTA, BDI, EPDS & STAI will be administered. Salivary OXT samples will be collected from the mother and from the infant and infants will undergo a developmental assessment.
intervention type: Drug
intervention name: Oxytocin
description: administered pre-fMRI assessment
arm group label: normal controls
arm group label: postpartum depression
other name: Syntocinon
intervention type: Drug
intervention name: placebo
description: administered pre-fMRI assessment
arm group label: normal controls
arm group label: postpartum depression
intervention type: Behavioral
intervention name: Dyadic psychotherapy
arm group label: postpartum depression
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Miki Bloch, Prof.
phone: 972-3-6974707
email: mikib@tlvmc.gov.il
last name: Ruth Feldman, PhD
phone: 972-3-5317943
email: ortalsh@hotmail.com
facility: 
investigator: 
country: Israel
responsible party type: Sponsor
mesh term: Depression, Postpartum
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Oxytocin