Attention Deficit Hyperactivity Disorder (ADHD)NCT02257216
Vayarin® Medical Food Study for Adults With Attention Deficit Hyperactivity Disorder (ADHD)
A study testing Vayarin® in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Enzymotec at 4 sites in United States.
Trial summary
The primary study objective is to evaluate the efficacy of Vayarin in ADHD adults. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- Vayarin®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 171 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2014to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Northwest Behavioral Research Center
Marietta, Georgia, 30060
Bioscience Research, LLC
Mount Kisco, New York, 10549
New York University School of Medicine
New York, New York, 10016
The Medical Research Network, LLC
New York, New York, 10128
About this study
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)
The primary study objective is to evaluate the efficacy of Vayarin in ADHD adults.
- Being tested
- Vayarin®, Placebo
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vayarin®Other
Medical Food
PlaceboOther
Cellulose
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: Treatment/Treatment | Active comparator | Treatment/Treatment- consists of Vayarin® for 8 weeks followed by 8 weeks of additional treatment with Vayarin® Receives: Other: Vayarin® |
| Sequence 2: Placebo/Treatment | Active comparator | Placebo/Treatment- consists of Placebo for 8 weeks followed by 8 weeks of treatment with Vayarin® Receives: 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adult ADHD Investigator Symptom Rating Scale (AISRS) total score
Measured: over 16 weeks
Secondary outcomes (8)
AISRS
Measured: over 16 weeks
Adult ADHD Self-Report Scale (ASRS)
Measured: over 16 weeks
Clinician Global Impression-Severity (CGI-S)
Measured: over 16 weeks
Clinician Global Impression improvement (CGI-I)
Measured: over 16 weeks
Behavior Rating Inventory of Executive Function for adults (BRIEF-A)
Measured: over 16 weeks
Pittsburgh Sleep Quality Index (PSQI)
Measured: over 16 weeks
Adult ADHD Quality of Life Measure (AAQoL)
Measured: over 16 weeks
Adverse events monitoring
Measured: over 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enzymotec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lenard A Adler, M.D, Principal investigator, NYU Langone HealthMichael Banov, M.D, Principal investigator, Northwest Behavioral Research CenterMichael R Liebowitz, M.D, Principal investigator, The Medical Research Network, LLCDavid S Krakow, M.D, Principal investigator, Bioscience Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02257216
- Sponsor's protocol ID
- Vayarin®_006
- Status last verified
- Jan 2017
- First submitted
- 2 Oct 2014
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02257216
- Acronym / sponsor ID
- Vayarin®_006
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- EnzymotecIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- May 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 6 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary study objective is to evaluate the efficacy of Vayarin in ADHD adults.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: Treatment/Treatment | Active comparator | Other: Vayarin®Treatment/Treatment- consists of Vayarin® for 8 weeks followed by 8 weeks of additional treatment with Vayarin® |
| Sequence 2: Placebo/Treatment | Active comparator | Other: Vayarin®, Other: PlaceboPlacebo/Treatment- consists of Placebo for 8 weeks followed by 8 weeks of treatment with Vayarin® |
| Sequence 3: Placebo/Placebo | Placebo comparator | Other: PlaceboPlacebo/Placebo- consists of Placebo for 8 weeks followed by 8 weeks of additional treatment with Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (17 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vayarin®Medical Food | Other | Sequence 1: Treatment/Treatment, Sequence 2: Placebo/Treatment |
| PlaceboCellulose | Other | Sequence 2: Placebo/Treatment, Sequence 3: Placebo/Placebo |
Primary outcome
Adult ADHD Investigator Symptom Rating Scale (AISRS) total score
Time frame: over 16 weeks
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lenard A Adler, M.D principal investigator
NYU Langone Health
Michael Banov, M.D principal investigator
Northwest Behavioral Research Center
Michael R Liebowitz, M.D principal investigator
The Medical Research Network, LLC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vayarin® in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Enzymotec at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adult ADHD Investigator Symptom Rating Scale (AISRS) total score (time frame: over 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2018.