<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/NCT02257216</url>
  </required_header>
  <id_info>
    <org_study_id>Vayarin®_006</org_study_id>
    <nct_id>NCT02257216</nct_id>
  </id_info>
  <brief_title>Vayarin® Medical Food Study for Adults With Attention Deficit Hyperactivity Disorder (ADHD)</brief_title>
  <official_title>A Randomized, Sequential Parallel, Double-Blind, Placebo- Controlled Medical Food Study for the Safety and Efficacy of Vayarin® in Adults With Attention Deficit Hyperactivity Disorder (ADHD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Enzymotec</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Enzymotec</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary study objective is to evaluate the efficacy of Vayarin in ADHD adults.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</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>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adult ADHD Investigator Symptom Rating Scale (AISRS) total score</measure>
    <time_frame>over 16 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>AISRS</measure>
    <time_frame>over 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adult ADHD Self-Report Scale (ASRS)</measure>
    <time_frame>over 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician Global Impression-Severity (CGI-S)</measure>
    <time_frame>over 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician Global Impression improvement (CGI-I)</measure>
    <time_frame>over 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavior Rating Inventory of Executive Function for adults (BRIEF-A)</measure>
    <time_frame>over 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pittsburgh Sleep Quality Index (PSQI)</measure>
    <time_frame>over 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adult ADHD Quality of Life Measure (AAQoL)</measure>
    <time_frame>over 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events monitoring</measure>
    <time_frame>over 16 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">171</enrollment>
  <condition>Attention Deficit Hyperactivity Disorder (ADHD)</condition>
  <arm_group>
    <arm_group_label>Sequence 1: Treatment/Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment/Treatment- consists of Vayarin® for 8 weeks followed by 8 weeks of additional treatment with Vayarin®</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 2: Placebo/Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Placebo/Treatment- consists of Placebo for 8 weeks followed by 8 weeks of treatment with Vayarin®</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence 3: Placebo/Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo/Placebo- consists of Placebo for 8 weeks followed by 8 weeks of additional treatment with Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vayarin®</intervention_name>
    <description>Medical Food</description>
    <arm_group_label>Sequence 1: Treatment/Treatment</arm_group_label>
    <arm_group_label>Sequence 2: Placebo/Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Cellulose</description>
    <arm_group_label>Sequence 2: Placebo/Treatment</arm_group_label>
    <arm_group_label>Sequence 3: Placebo/Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female age 18-60 inclusive.&#xD;
&#xD;
          2. Primary diagnosis of ADHD&#xD;
&#xD;
          3. At least 50% of the sample will have an abnormal score on the Emotional Control&#xD;
             subscale of the BRIEF-A of ≥65.&#xD;
&#xD;
          4. AISRS total score ≥ 24&#xD;
&#xD;
          5. CGI-S ≥4 (moderately ill or worse).&#xD;
&#xD;
          6. Subjects in ongoing psychotherapy will be allowed, but no significant changes in the&#xD;
             frequency, type or intensity of the therapy are to be made during the course of their&#xD;
             study participation per the discretion of the principal investigator. The subject must&#xD;
             be in psychotherapy at least 4 weeks prior to the screening visit.&#xD;
&#xD;
          7. Understands and is able, willing, and likely to fully comply with the study procedures&#xD;
             and restrictions.&#xD;
&#xD;
          8. Has given written informed consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. BMI less than18.5 or greater than 35.&#xD;
&#xD;
          2. Any underlying/ history or current diagnosis of systemic and/or metabolic disease&#xD;
             (e.g. diabetes, Crohn's disease) and/or neurological condition state that may render&#xD;
             the subject illegible to participate in the study as assessed by medical history,&#xD;
             physical exam, clinical and lab evaluation.&#xD;
&#xD;
          3. History of uncontrolled hypertension or a resting systolic blood pressure &gt; 140mmHg or&#xD;
             diastolic blood pressure &gt; 90mmHg (Subjects with well controlled hypertension on a&#xD;
             stable dose (2 months) of anti-hypertensives will be allowed to participate).&#xD;
&#xD;
          4. Hamilton Anxiety Scale (HAM-A) ≥ 17).&#xD;
&#xD;
          5. Hamilton Depression scale (HAM-D ≥ 13).&#xD;
&#xD;
          6. Major depression or anxiety disorder which is a focus of treatment or requires taking&#xD;
             medication.&#xD;
&#xD;
          7. A lifetime history of psychosis or bipolar disorder based on a clinician-administered&#xD;
             interview using the Mini International Neuropsychiatric Interview (M.I.N.I 7.0).&#xD;
             Subjects with mild to moderate forms of social phobia and dysthymia, not requiring&#xD;
             treatment, will be allowed.&#xD;
&#xD;
          8. Has any concurrent chronic or unstable medical condition that could confound with the&#xD;
             results of safety assessments, increase risk to the subject or lead to difficulty&#xD;
             complying with the protocol.&#xD;
&#xD;
          9. Subjects taking any medication with CNS effects (excluding subjects who discontinue&#xD;
             the medications at least 2 weeks prior to the study for stimulants and 4 weeks for&#xD;
             SSRI, non-stimulants, and alpha 2-agonist).&#xD;
&#xD;
         10. Subjects with a history of two or more prior failed adequate trials of ADHD treatment&#xD;
             due to adverse events.&#xD;
&#xD;
         11. Use of dietary supplements with potential CNS effect, including omega-3 supplements,&#xD;
             30 days before study initiation and throughout the study.&#xD;
&#xD;
         12. Clinical history of cognitive impairment in judgment of investigator.&#xD;
&#xD;
         13. Pregnant or breast-feeding subjects. Women of childbearing potential must have a&#xD;
             negative pregnancy test performed at screening visit prior to randomization. Women of&#xD;
             childbearing potential must agree to use adequate birth control for the entire&#xD;
             duration of the study.&#xD;
&#xD;
         14. Subjects with a current (within the last 3 months) DSM-V diagnosis of alcohol or drug&#xD;
             abuse or dependence (excluding nicotine).&#xD;
&#xD;
         15. Known history of allergic reactions or sensitivity to marine products (fish and&#xD;
             seafood), or soy.&#xD;
&#xD;
         16. Has taken an investigational drug or taken part in a clinical trial within 30 days&#xD;
             prior to screening.&#xD;
&#xD;
         17. Any other reason that, in the opinion of the investigator, prevents the subject from&#xD;
             participating in the study or compromise the subject safety.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lenard A Adler, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael Banov, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwest Behavioral Research Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael R Liebowitz, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Medical Research Network, LLC</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David S Krakow, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bioscience Research, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwest Behavioral Research Center</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bioscience Research, LLC</name>
      <address>
        <city>Mount Kisco</city>
        <state>New York</state>
        <zip>10549</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York University School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Medical Research Network, LLC</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>April 10, 2018</last_update_submitted>
  <last_update_submitted_qc>April 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <!-- 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/NCT02257216
org study id: Vayarin®_006
nct id: NCT02257216
lead sponsor: 
has dmc: No
The primary study objective is to evaluate the efficacy of Vayarin in ADHD adults.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Adult ADHD Investigator Symptom Rating Scale (AISRS) total score
time frame: over 16 weeks
measure: AISRS
time frame: over 16 weeks
measure: Adult ADHD Self-Report Scale (ASRS)
time frame: over 16 weeks
measure: Clinician Global Impression-Severity (CGI-S)
time frame: over 16 weeks
measure: Clinician Global Impression improvement (CGI-I)
time frame: over 16 weeks
measure: Behavior Rating Inventory of Executive Function for adults (BRIEF-A)
time frame: over 16 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
time frame: over 16 weeks
measure: Adult ADHD Quality of Life Measure (AAQoL)
time frame: over 16 weeks
measure: Adverse events monitoring
time frame: over 16 weeks
arm group label: Sequence 1: Treatment/Treatment
arm group type: Active Comparator
description: Treatment/Treatment- consists of Vayarin® for 8 weeks followed by 8 weeks of additional treatment with Vayarin®
arm group label: Sequence 2: Placebo/Treatment
arm group type: Active Comparator
description: Placebo/Treatment- consists of Placebo for 8 weeks followed by 8 weeks of treatment with Vayarin®
arm group label: Sequence 3: Placebo/Placebo
arm group type: Placebo Comparator
description: Placebo/Placebo- consists of Placebo for 8 weeks followed by 8 weeks of additional treatment with Placebo
intervention type: Other
intervention name: Vayarin®
description: Medical Food
arm group label: Sequence 1: Treatment/Treatment
arm group label: Sequence 2: Placebo/Treatment
intervention type: Other
intervention name: Placebo
description: Cellulose
arm group label: Sequence 2: Placebo/Treatment
arm group label: Sequence 3: Placebo/Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Lenard A Adler, M.D
role: Principal Investigator
affiliation: NYU Langone Health
last name: Michael Banov, M.D
role: Principal Investigator
affiliation: Northwest Behavioral Research Center
last name: Michael R Liebowitz, M.D
role: Principal Investigator
affiliation: The Medical Research Network, LLC
last name: David S Krakow, M.D
role: Principal Investigator
affiliation: Bioscience Research, LLC
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hyperkinesis
mesh term: Attention Deficit Disorder with Hyperactivity