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

Study Overview
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Brief Summary
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The primary study objective is to evaluate the efficacy of Vayarin in ADHD adults.

Official Title
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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)

Conditions
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Attention Deficit Hyperactivity Disorder (ADHD)

Intervention / Treatment
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* Other: Vayarin®
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. Has taken an investigational drug or taken part in a clinical trial within 30 days prior to screening. Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sequence 1: Treatment/Treatment<br>Treatment/Treatment- consists of Vayarin® for 8 weeks followed by 8 weeks of additional treatment with Vayarin® | Other: Vayarin®<br>* Medical Food<br>|
| Active Comparator: Sequence 2: Placebo/Treatment<br>Placebo/Treatment- consists of Placebo for 8 weeks followed by 8 weeks of treatment with Vayarin® | Other: Vayarin®<br>* Medical Food<br>Other: Placebo<br>* Cellulose<br>|
| Placebo Comparator: Sequence 3: Placebo/Placebo<br>Placebo/Placebo- consists of Placebo for 8 weeks followed by 8 weeks of additional treatment with Placebo | Other: Placebo<br>* Cellulose<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |