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

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)

The primary study objective is to evaluate the efficacy of Vayarin in ADHD adults.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
• Intervention / Treatment: Other: Placebo; Other: Vayarin®

• Study Type: Interventional
• Enrollment (Actual): 171
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Northwest Behavioral Research Center
  • New York
    • Mount Kisco, New York, United States, 10549
      • Bioscience Research, LLC
    • New York, New York, United States, 10016
      • New York University School of Medicine
    • New York, New York, United States, 10128
      • The Medical Research Network, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Placebo; Cellulose; Other: Vayarin®; Medical Food
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adult ADHD Investigator Symptom Rating Scale (AISRS) total score	over 16 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Enzymotec
• Investigators: Principal Investigator: Lenard A Adler, M.D, NYU Langone Health; 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

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: October 2, 2014
• First Submitted That Met QC Criteria: October 3, 2014
• First Posted (Estimate): October 6, 2014

Study Record Updates

• Last Update Posted (Actual): April 11, 2018
• Last Update Submitted That Met QC Criteria: April 10, 2018
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: Vayarin®_006