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Vayarin® Medical Food Study for Adults With Attention Deficit Hyperactivity Disorder (ADHD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Enzymotec
ClinicalTrials.gov Identifier:
NCT02257216
First received: October 2, 2014
Last updated: July 16, 2017
Last verified: January 2017
  Purpose
The primary study objective is to evaluate the efficacy of Vayarin in ADHD adults.

Condition Intervention
Attention Deficit Hyperactivity Disorder (ADHD) Other: Vayarin® Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
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)

Resource links provided by NLM:


Further study details as provided by Enzymotec:

Primary Outcome Measures:
  • Adult ADHD Investigator Symptom Rating Scale (AISRS) total score [ Time Frame: over 16 weeks ]

Secondary Outcome Measures:
  • AISRS [ Time Frame: over 16 weeks ]
  • Adult ADHD Self-Report Scale (ASRS) [ Time Frame: over 16 weeks ]
  • Clinician Global Impression-Severity (CGI-S) [ Time Frame: over 16 weeks ]
  • Clinician Global Impression improvement (CGI-I) [ Time Frame: over 16 weeks ]
  • Behavior Rating Inventory of Executive Function for adults (BRIEF-A) [ Time Frame: over 16 weeks ]
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: over 16 weeks ]
  • Adult ADHD Quality of Life Measure (AAQoL) [ Time Frame: over 16 weeks ]
  • Adverse events monitoring [ Time Frame: over 16 weeks ]

Estimated Enrollment: 171
Study Start Date: October 2014
Study Completion Date: June 2017
Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sequence 1: Treatment/Treatment
Treatment/Treatment- consists of Vayarin® for 8 weeks followed by 8 weeks of additional treatment with Vayarin®
Other: Vayarin®
Medical Food
Active Comparator: Sequence 2: Placebo/Treatment
Placebo/Treatment- consists of Placebo for 8 weeks followed by 8 weeks of treatment with Vayarin®
Other: Vayarin®
Medical Food
Other: Placebo
Cellulose
Placebo Comparator: Sequence 3: Placebo/Placebo
Placebo/Placebo- consists of Placebo for 8 weeks followed by 8 weeks of additional treatment with Placebo
Other: Placebo
Cellulose

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female age 18-60 inclusive.
  2. Primary diagnosis of ADHD
  3. At least 50% of the sample will have an abnormal score on the Emotional Control subscale of the BRIEF-A of ≥65.
  4. AISRS total score ≥ 24
  5. CGI-S ≥4 (moderately ill or worse).
  6. Subjects in ongoing psychotherapy will be allowed, but no significant changes in the frequency, type or intensity of the therapy are to be made during the course of their study participation per the discretion of the principal investigator. The subject must be in psychotherapy at least 4 weeks prior to the screening visit.
  7. Understands and is able, willing, and likely to fully comply with the study procedures and restrictions.
  8. Has given written informed consent to participate in the study.

Exclusion Criteria:

  1. BMI less than18.5 or greater than 35.
  2. Any underlying/ history or current diagnosis of systemic and/or metabolic disease (e.g. diabetes, Crohn's disease) and/or neurological condition state that may render the subject illegible to participate in the study as assessed by medical history, physical exam, clinical and lab evaluation.
  3. History of uncontrolled hypertension or a resting systolic blood pressure > 140mmHg or diastolic blood pressure > 90mmHg (Subjects with well controlled hypertension on a stable dose (2 months) of anti-hypertensives will be allowed to participate).
  4. Hamilton Anxiety Scale (HAM-A) ≥ 17).
  5. Hamilton Depression scale (HAM-D ≥ 13).
  6. Major depression or anxiety disorder which is a focus of treatment or requires taking medication.
  7. A lifetime history of psychosis or bipolar disorder based on a clinician-administered interview using the Mini International Neuropsychiatric Interview (M.I.N.I 7.0). Subjects with mild to moderate forms of social phobia and dysthymia, not requiring treatment, will be allowed.
  8. Has any concurrent chronic or unstable medical condition that could confound with the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol.
  9. Subjects taking any medication with CNS effects (excluding subjects who discontinue the medications at least 2 weeks prior to the study for stimulants and 4 weeks for SSRI, non-stimulants, and alpha 2-agonist).
  10. Subjects with a history of two or more prior failed adequate trials of ADHD treatment due to adverse events.
  11. Use of dietary supplements with potential CNS effect, including omega-3 supplements, 30 days before study initiation and throughout the study.
  12. Clinical history of cognitive impairment in judgment of investigator.
  13. Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative pregnancy test performed at screening visit prior to randomization. Women of childbearing potential must agree to use adequate birth control for the entire duration of the study.
  14. Subjects with a current (within the last 3 months) DSM-V diagnosis of alcohol or drug abuse or dependence (excluding nicotine).
  15. Known history of allergic reactions or sensitivity to marine products (fish and seafood), or soy.
  16. Has taken an investigational drug or taken part in a clinical trial within 30 days prior to screening.
  17. Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02257216

Locations
United States, Georgia
Northwest Behavioral Research Center
Marietta, Georgia, United States, 30060
United States, New York
Bioscience Research, LLC
Mount Kisco, New York, United States, 10549
New York University School of Medicine
New York, New York, United States, 10016
The Medical Research Network, LLC
New York, New York, United States, 10128
Sponsors and Collaborators
Enzymotec
Investigators
Principal Investigator: Lenard A Adler, M.D New York University School of Medicine
Principal Investigator: Michael Banov, M.D Northwest Behavioral Research Center
Principal Investigator: Michael R Liebowitz, M.D The Medical Research Network, LLC
Principal Investigator: David S Krakow, M.D Bioscience Research, LLC
  More Information

Responsible Party: Enzymotec
ClinicalTrials.gov Identifier: NCT02257216     History of Changes
Other Study ID Numbers: Vayarin®_006
Study First Received: October 2, 2014
Last Updated: July 16, 2017

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 19, 2017