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

NCT02257216 | Completed

• 1 other identifier: Vayarin®_006
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Outcome Measures

Primary Outcomes (1)

• Adult ADHD Investigator Symptom Rating Scale (AISRS) total score

  over 16 weeks

Secondary Outcomes (8)

• 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

Study Arms (3)

Sequence 1: Treatment/Treatment

ACTIVE COMPARATOR

Treatment/Treatment- consists of Vayarin® for 8 weeks followed by 8 weeks of additional treatment with Vayarin®

Other: Vayarin®

Sequence 2: Placebo/Treatment

ACTIVE COMPARATOR

Placebo/Treatment- consists of Placebo for 8 weeks followed by 8 weeks of treatment with Vayarin®

Other: Vayarin®; Other: Placebo

Sequence 3: Placebo/Placebo

PLACEBO COMPARATOR

Placebo/Placebo- consists of Placebo for 8 weeks followed by 8 weeks of additional treatment with Placebo

Other: Placebo

Interventions

Vayarin® OTHER

Medical Food

Sequence 1: Treatment/Treatment; Sequence 2: Placebo/Treatment

Placebo OTHER

Cellulose

Sequence 2: Placebo/Treatment; Sequence 3: Placebo/Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female age 18-60 inclusive.
• Primary diagnosis of ADHD
• At least 50% of the sample will have an abnormal score on the Emotional Control subscale of the BRIEF-A of ≥65.
• AISRS total score ≥ 24
• CGI-S ≥4 (moderately ill or worse).
• 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.
• Understands and is able, willing, and likely to fully comply with the study procedures and restrictions.
• Has given written informed consent to participate in the study.

You may not qualify if:

• BMI less than18.5 or greater than 35.
• 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.
• 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).
• Hamilton Anxiety Scale (HAM-A) ≥ 17).
• Hamilton Depression scale (HAM-D ≥ 13).
• Major depression or anxiety disorder which is a focus of treatment or requires taking medication.
• 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.
• 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.
• 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).
• Subjects with a history of two or more prior failed adequate trials of ADHD treatment due to adverse events.
• Use of dietary supplements with potential CNS effect, including omega-3 supplements, 30 days before study initiation and throughout the study.
• Clinical history of cognitive impairment in judgment of investigator.
• 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.
• Subjects with a current (within the last 3 months) DSM-V diagnosis of alcohol or drug abuse or dependence (excluding nicotine).
• Known history of allergic reactions or sensitivity to marine products (fish and seafood), or soy.

Sponsors & Collaborators

• Enzymotec: lead

Study Sites (4)

Northwest Behavioral Research Center

Marietta, Georgia, 30060, United States

Location

Bioscience Research, LLC

Mount Kisco, New York, 10549, United States

Location

New York University School of Medicine

New York, New York, 10016, United States

Location

The Medical Research Network, LLC

New York, New York, 10128, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: October 6, 2014
• Study Start: October 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: June 1, 2017
• Last Updated: April 11, 2018

Record last verified: 2017-01

Locations

US (4)