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NCT01074294 · ClinicalTrials.gov registry record · Phase 2
Study of the Safety and Efficacy of OPC-34712 as a Complementary Therapy in the Treatment of Adult Attention Deficit/Hyperactivity Disorder
A Phase 2 study of Attention Deficit Hyperactivity Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 2
- Development phase
- 740
- Enrollment target
- 20
- Study locations
NCT01074294: Completed Phase 2 study of Attention Deficit Hyperactivity Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT01074294 is a Phase 2 study of Attention Deficit Hyperactivity Disorder that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 740 participants, above the 209-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (254% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01074294, a Phase 2 study of Attention Deficit Hyperactivity Disorder, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 740 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study tests the effects of an investigational antipsychotic drug (called OPC-34712) in adults with attention deficit hyperactivity disorder (ADHD) when taken with an approved stimulant medication to explore a possible impact on sleep, quality of life and cognitive function.
Primary Outcome
The CAARS-O:SV is a 30 items scale with 3 subscales: Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Inattentive Symptoms (9 items), DSM- IV Hyperactive/Impulsive Symptoms (9 items), and DSM-IV ADHD Index (12 items). Total ADHD Symptoms Score (18 items) consisted of the combined score for the inattentive symptoms and hyperactive/impulsive symptoms subscales and is scored on a 4-point scale from 0 (not at all; never) to 3 (very much, very frequently) for a total score ranging from
Conditions Studied
Interventions
- DRUG Placebo
- DRUG OPDC-34712
- DRUG Stimulant Therapy
Study Locations (20)
Florida
- - Bradenton
- - Jacksonville
- - Maitland
- - North Miami
- - Orlando
- - South Miami
California
- - Beverly Hills
- - Irvine
- - Pasadena
- - San Francisco
Georgia
- - Atlanta
- - Smyrna
New Jersey
- - Cherry Hill
- - Willingboro
Arkansas
- - Little Rock
Indiana
- - Indianapolis
Kansas
- - Overland Park
Michigan
- - Rochester Hills
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 740 participants |
| Start Date | 2010-03-16 |
| Est. Completion | 2011-06-20 |
| Phase | Phase 2 |
What the finished NCT01074294 record still lists
NCT01074294 is an interventional study that assigns participants to a tested intervention. The registered 740 participants enrollment target is mid-sized for trials with a published cap, above the 209-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (254% higher).
The record links to 1 condition, with Attention Deficit Hyperactivity Disorder appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01074294 names 20 study sites across 10 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT01074294 about?
NCT01074294 is a clinical study titled "Study of the Safety and Efficacy of OPC-34712 as a Complementary Therapy in the Treatment of Adult Attention Deficit/Hyperactivity Disorder". This study tests the effects of an investigational antipsychotic drug (called OPC-34712) in adults with attention deficit hyperactivity disorder (ADHD) when taken with an approved stimulant medication to explore a possible impact on sleep, quality of life and cognitive function.
What is the current status of trial NCT01074294?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 740 participants. The study started on 2010-03-16. Estimated completion is 2011-06-20.
What conditions does trial NCT01074294 study?
This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder.
What interventions are being tested in trial NCT01074294?
The interventions under investigation include: Placebo (DRUG), OPDC-34712 (DRUG), Stimulant Therapy (DRUG).
Who is sponsoring clinical trial NCT01074294?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01074294 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01074294's enrollment target sits among peer trials
740 5th of 102 higher than 98 of 102 other Attention Deficit Hyperactivity Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Attention Deficit Hyperactivity Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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