<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/NCT02204410</url>
  </required_header>
  <id_info>
    <org_study_id>2014-P-000015</org_study_id>
    <nct_id>NCT02204410</nct_id>
  </id_info>
  <brief_title>Omega-3 Supplementation to ADHD Medication in Children</brief_title>
  <official_title>A Pilot Study of Omega-3 Fatty Acid Supplementation to ADHD Medication in Children With ADHD and Deficits in Emotional Self-Regulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a 12-week open-label trial to assess the effectiveness of Omega-3 fatty acids&#xD;
      for deficient emotional self-regulation (DESR) as a supplement to Attention&#xD;
      Deficit/Hyperactivity Disorder (ADHD) treatment in children and adolescents with Attention&#xD;
      Deficit/Hyperactivity Disorder. Subjects will be between the ages of 6-17 and will currently&#xD;
      be on medication for their Attention Deficit/Hyperactivity Disorder but still experience DESR&#xD;
      traits.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Emotional Control Subscale of the Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent)</measure>
    <time_frame>Baseline and 12 Weeks</time_frame>
    <description>The Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent) is a 75-item checklist with a large normative sample, internal consistency, test-retest reliability, inter-rater reliability, and external and concurrent validity, divided into nine empirically and theoretically derived and T-scored subscales. The Emotional Control subscale measures the impact of executive function problems on emotional expression and assesses a child's ability to modulate or control his or her emotional responses. It is a 10-item subscale, and each item is scored &quot;Never,&quot; &quot;Sometimes,&quot; or &quot;Often.&quot; Raw scores for all scales are computed with Software Portfolio (BRIEF-SP), which provides a raw score and T score (based on child's age) for each scale. Higher scores represent more greater emotional dysregulation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Global Impression (CGI) Improvement for Deficient Emotional Self-Regulation (DESR)</measure>
    <time_frame>Baseline and 12 Weeks</time_frame>
    <description>The Clinical Global Impression (CGI) is a clinician rated measure of illness severity, improvement, and efficacy of treatment (collected at all study visits). We examined the CGI Improvement specifically. The CGI Improvement for Deficient Emotional Self-Regulation (DESR) was reported at baseline and completion. The CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. It is rated as:&#xD;
Very much improved&#xD;
Much improved&#xD;
Minimally improved&#xD;
No change&#xD;
Minimally worse&#xD;
Much worse&#xD;
Very much worse</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Attention Deficit Hyperactivity Disorder</condition>
  <condition>Deficient Emotional Self-Regulation</condition>
  <arm_group>
    <arm_group_label>Omega-3 Fatty Acids and Stimulant Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive open-label treatment with Omega-3 Fatty Acids. All participants must also be treated with a stable dose of a traditional ADHD medication at the time of enrollment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Omega-3 Fatty Acid</intervention_name>
    <arm_group_label>Omega-3 Fatty Acids and Stimulant Treatment</arm_group_label>
    <other_name>Fish Oil</other_name>
    <other_name>Nordic Naturals Pro-Omega Junior Omega-3 Fatty Acid</other_name>
    <other_name>Nordic Omega-3 Fishies</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ADHD Medication</intervention_name>
    <arm_group_label>Omega-3 Fatty Acids and Stimulant Treatment</arm_group_label>
    <other_name>Stimulant</other_name>
    <other_name>Concerta</other_name>
    <other_name>Ritalin</other_name>
    <other_name>Focalin</other_name>
    <other_name>Vyvanse</other_name>
    <other_name>Adderall</other_name>
    <other_name>Dexedrine</other_name>
    <other_name>Amphetamine</other_name>
    <other_name>Methylphenidate</other_name>
    <other_name>Stratterra</other_name>
    <other_name>Tenex</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female children ages 6-17 years&#xD;
&#xD;
          -  Living at home&#xD;
&#xD;
          -  A diagnosis of ADHD (inattentive, hyperactive/impulsive, or combined type) according&#xD;
             to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)&#xD;
             based on clinical assessment&#xD;
&#xD;
          -  Having a score outside the normal (a T-score of 60 or greater) on the Emotional&#xD;
             Control subscale of the Behavior Rating Inventory of Executive Function (parent-report&#xD;
             version) or a score outside the normal range (cumulative of 180 or greater) on the&#xD;
             Anxious/Depressed, Attention Problems, and Aggressive Behavior subscales of the Child&#xD;
             Behavior Checklist for ages (6-18)&#xD;
&#xD;
          -  Currently on FDA approved traditional stimulant medication (such as Concerta of&#xD;
             Adderall XR) or non-stimulant medication (such as Strattera or Tenex) for their ADHD&#xD;
             for at least one month&#xD;
&#xD;
          -  Beings able to come to weekly/monthly study visits for 12 weeks&#xD;
&#xD;
          -  Having a parent or guardian with a level of understanding of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having unstable medical illness as determined by the clinician investigator&#xD;
&#xD;
          -  Having a current diagnosis of schizophrenia or bipolar disorder&#xD;
&#xD;
          -  Having delusions or hallucinations&#xD;
&#xD;
          -  Having a bleeding disorder&#xD;
&#xD;
          -  Taking any other ongoing non-ADHD psychotropic medications other than stable,&#xD;
             effective serotonin reuptake inhibitors such as fluoxetine (Prozac), citalopram&#xD;
             (Celexa) or medications used on an as-needed basis&#xD;
&#xD;
          -  Pregnant or nursing females&#xD;
&#xD;
          -  IQ &lt; 70 by previous testing or as judged by the clinician investigator&#xD;
&#xD;
          -  Illegal substance use&#xD;
&#xD;
          -  Investigator and his/her immediate family; defined as the investigator's spouse,&#xD;
             parent, child, grandparent, or grandchild&#xD;
&#xD;
          -  Presence of suicidal risk, or homicidality&#xD;
&#xD;
          -  Unwilling/unable to comply with study procedures&#xD;
&#xD;
          -  Allergies to fish or shellfish or omega 3 fish oils; multiple adverse drug reactions&#xD;
&#xD;
          -  Poor command of the English language&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Timothy E. Wilens, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <results_first_submitted>April 26, 2017</results_first_submitted>
  <results_first_submitted_qc>May 30, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">June 29, 2017</results_first_posted>
  <last_update_submitted>May 30, 2017</last_update_submitted>
  <last_update_submitted_qc>May 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Timothy Wilens, MD</investigator_full_name>
    <investigator_title>Senior Staff, Pediatric Psychopharmaoclogy and Adult ADHD Clinic and Research Program; Associate professor of Psychiatry, Harvard Medical School; Director, Center for Addiction Medicine</investigator_title>
  </responsible_party>
  <keyword>ADHD</keyword>
  <keyword>Attention Deficit Hyperactivity Disorder</keyword>
  <keyword>DESR</keyword>
  <keyword>Deficient Emotional Self-Regulation</keyword>
  <keyword>Emotional Dysregulation</keyword>
  <keyword>Omega-3 Fatty Acids</keyword>
  <keyword>Fish Oil</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperkinesis</mesh_term>
    <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methylphenidate</mesh_term>
    <mesh_term>Amphetamine</mesh_term>
    <mesh_term>Adderall</mesh_term>
    <mesh_term>Dextroamphetamine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>IRB-approved flyers were posted in the general community and throughout Massachusetts General Hospital between June 2014 and April 2016.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Omega-3 Fatty Acids and Stimulant Treatment</title>
          <description>Participants will receive open-label treatment with Omega-3 Fatty Acids. All participants must also be treated with a stable dose of a traditional ADHD medication at the time of enrollment.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Omega-3 Fatty Acids and Stimulant Treatment</title>
          <description>Participants will receive open-label treatment with Omega-3 Fatty Acids. All participants must also be treated with a stable dose of a traditional ADHD medication at the time of enrollment.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
          </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="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.6" spread="2.6"/>
                  </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="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </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="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Emotional Control Subscale of the Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent)</title>
        <description>The Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent) is a 75-item checklist with a large normative sample, internal consistency, test-retest reliability, inter-rater reliability, and external and concurrent validity, divided into nine empirically and theoretically derived and T-scored subscales. The Emotional Control subscale measures the impact of executive function problems on emotional expression and assesses a child's ability to modulate or control his or her emotional responses. It is a 10-item subscale, and each item is scored &quot;Never,&quot; &quot;Sometimes,&quot; or &quot;Often.&quot; Raw scores for all scales are computed with Software Portfolio (BRIEF-SP), which provides a raw score and T score (based on child's age) for each scale. Higher scores represent more greater emotional dysregulation.</description>
        <time_frame>Baseline and 12 Weeks</time_frame>
        <population>Ten participants completed at least 6 weeks of the 12 week trial. These 10 participants were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Omega-3 Fatty Acids and Stimulant Treatment</title>
            <description>Participants will receive open-label treatment with Omega-3 Fatty Acids. All participants must also be treated with a stable dose of a traditional ADHD medication at the time of enrollment.</description>
          </group>
        </group_list>
        <measure>
          <title>Emotional Control Subscale of the Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent)</title>
          <description>The Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent) is a 75-item checklist with a large normative sample, internal consistency, test-retest reliability, inter-rater reliability, and external and concurrent validity, divided into nine empirically and theoretically derived and T-scored subscales. The Emotional Control subscale measures the impact of executive function problems on emotional expression and assesses a child's ability to modulate or control his or her emotional responses. It is a 10-item subscale, and each item is scored &quot;Never,&quot; &quot;Sometimes,&quot; or &quot;Often.&quot; Raw scores for all scales are computed with Software Portfolio (BRIEF-SP), which provides a raw score and T score (based on child's age) for each scale. Higher scores represent more greater emotional dysregulation.</description>
          <population>Ten participants completed at least 6 weeks of the 12 week trial. These 10 participants were included in the analysis.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Emotional Control Subscale T Score Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.3" spread="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Control Subscale T Score Endpoint</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.4" spread="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Clinical Global Impression (CGI) Improvement for Deficient Emotional Self-Regulation (DESR)</title>
        <description>The Clinical Global Impression (CGI) is a clinician rated measure of illness severity, improvement, and efficacy of treatment (collected at all study visits). We examined the CGI Improvement specifically. The CGI Improvement for Deficient Emotional Self-Regulation (DESR) was reported at baseline and completion. The CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. It is rated as:&#xD;
Very much improved&#xD;
Much improved&#xD;
Minimally improved&#xD;
No change&#xD;
Minimally worse&#xD;
Much worse&#xD;
Very much worse</description>
        <time_frame>Baseline and 12 Weeks</time_frame>
        <population>Ten participants completed at least 6 weeks of the 12 week trial. These 10 participants were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Omega-3 Fatty Acids and Stimulant Treatment</title>
            <description>Participants will receive open-label treatment with Omega-3 Fatty Acids. All participants must also be treated with a stable dose of a traditional ADHD medication at the time of enrollment.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Global Impression (CGI) Improvement for Deficient Emotional Self-Regulation (DESR)</title>
          <description>The Clinical Global Impression (CGI) is a clinician rated measure of illness severity, improvement, and efficacy of treatment (collected at all study visits). We examined the CGI Improvement specifically. The CGI Improvement for Deficient Emotional Self-Regulation (DESR) was reported at baseline and completion. The CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. It is rated as:&#xD;
Very much improved&#xD;
Much improved&#xD;
Minimally improved&#xD;
No change&#xD;
Minimally worse&#xD;
Much worse&#xD;
Very much worse</description>
          <population>Ten participants completed at least 6 weeks of the 12 week trial. These 10 participants were included in the analysis.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CGI Improvement for DESR Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGI Improvement for DESR Endpoint</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from 10/1/2014 to 6/1/2016.</time_frame>
      <desc>Twelve subjects began taking taking open-label treatment with Omega-3 Fatty Acids. All of these subject's are included in adverse event reporting.&#xD;
Ten participants completed a minimum of 6 weeks of the 12 week trial. These 10 participants are included in the data analysis.</desc>
      <group_list>
        <group group_id="E1">
          <title>Omega-3 Fatty Acids and Stimulant Treatment</title>
          <description>Participants will receive open-label treatment with Omega-3 Fatty Acids. All participants must also be treated with a stable dose of a traditional ADHD medication at the time of enrollment.</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="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>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="9" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Cold/Infection/Allergy</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Weight Gain/Increased Appetite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Agitated/Tearful</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Decreased Energy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Suicidal Ideation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Increased Anxiety</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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. Timothy Wilens</name_or_title>
      <organization>Massachusetts General Hospital</organization>
      <phone>(617)643-3481</phone>
      <email>twilens@mgh.harvard.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/NCT02204410
org study id: 2014-P-000015
nct id: NCT02204410
lead sponsor: 
has dmc: No
This study is a 12-week open-label trial to assess the effectiveness of Omega-3 fatty acids
      for deficient emotional self-regulation (DESR) as a supplement to Attention
      Deficit/Hyperactivity Disorder (ADHD) treatment in children and adolescents with Attention
      Deficit/Hyperactivity Disorder. Subjects will be between the ages of 6-17 and will currently
      be on medication for their Attention Deficit/Hyperactivity Disorder but still experience DESR
      traits.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Emotional Control Subscale of the Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent)
time frame: Baseline and 12 Weeks
description: The Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent) is a 75-item checklist with a large normative sample, internal consistency, test-retest reliability, inter-rater reliability, and external and concurrent validity, divided into nine empirically and theoretically derived and T-scored subscales. The Emotional Control subscale measures the impact of executive function problems on emotional expression and assesses a child's ability to modulate or control his or her emotional responses. It is a 10-item subscale, and each item is scored "Never," "Sometimes," or "Often." Raw scores for all scales are computed with Software Portfolio (BRIEF-SP), which provides a raw score and T score (based on child's age) for each scale. Higher scores represent more greater emotional dysregulation.
measure: Clinical Global Impression (CGI) Improvement for Deficient Emotional Self-Regulation (DESR)
time frame: Baseline and 12 Weeks
description: The Clinical Global Impression (CGI) is a clinician rated measure of illness severity, improvement, and efficacy of treatment (collected at all study visits). We examined the CGI Improvement specifically. The CGI Improvement for Deficient Emotional Self-Regulation (DESR) was reported at baseline and completion. The CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. It is rated as:
Very much improved
Much improved
Minimally improved
No change
Minimally worse
Much worse
Very much worse
arm group label: Omega-3 Fatty Acids and Stimulant Treatment
arm group type: Experimental
description: Participants will receive open-label treatment with Omega-3 Fatty Acids. All participants must also be treated with a stable dose of a traditional ADHD medication at the time of enrollment.
intervention type: Dietary Supplement
intervention name: Omega-3 Fatty Acid
arm group label: Omega-3 Fatty Acids and Stimulant Treatment
other name: Fish Oil
other name: Nordic Naturals Pro-Omega Junior Omega-3 Fatty Acid
other name: Nordic Omega-3 Fishies
intervention type: Drug
intervention name: ADHD Medication
arm group label: Omega-3 Fatty Acids and Stimulant Treatment
other name: Stimulant
other name: Concerta
other name: Ritalin
other name: Focalin
other name: Vyvanse
other name: Adderall
other name: Dexedrine
other name: Amphetamine
other name: Methylphenidate
other name: Stratterra
other name: Tenex
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
healthy volunteers: No
last name: Timothy E. Wilens, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Timothy Wilens, MD
investigator title: Senior Staff, Pediatric Psychopharmaoclogy and Adult ADHD Clinic and Research Program; Associate professor of Psychiatry, Harvard Medical School; Director, Center for Addiction Medicine
mesh term: Hyperkinesis
mesh term: Attention Deficit Disorder with Hyperactivity
mesh term: Methylphenidate
mesh term: Amphetamine
mesh term: Adderall
mesh term: Dextroamphetamine
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 