Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary study objective is to evaluate the efficacy of Vayarin in ADHD adults.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: Treatment/Treatment | Active Comparator | Treatment/Treatment- consists of Vayarin® for 8 weeks followed by 8 weeks of additional treatment with Vayarin® |
|
| Sequence 2: Placebo/Treatment | Active Comparator | Placebo/Treatment- consists of Placebo for 8 weeks followed by 8 weeks of treatment with Vayarin® |
|
| Sequence 3: Placebo/Placebo | Placebo Comparator | Placebo/Placebo- consists of Placebo for 8 weeks followed by 8 weeks of additional treatment with Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vayarin® | Other | Medical Food |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adult ADHD Investigator Symptom Rating Scale (AISRS) total score | over 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| AISRS | over 16 weeks | |
| Adult ADHD Self-Report Scale (ASRS) | over 16 weeks | |
| Clinician Global Impression-Severity (CGI-S) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwest Behavioral Research Center | Marietta | Georgia | 30060 | United States | ||
| Bioscience Research, LLC |
Not provided
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Cellulose |
|
| 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 |
| Mount Kisco |
| New York |
| 10549 |
| United States |
| New York University School of Medicine | New York | New York | 10016 | United States |
| The Medical Research Network, LLC | New York | New York | 10128 | United States |