CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 740 enrolled
Drug / intervention
OPDC-34712 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01074294
NCT01074294Phase 2Completed
CompareCT.gov

A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Adult Attention Deficit/ Hyperactivity Disorder

Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Feb 24, 2010·Updated Feb 2, 2023

In Brief

A Phase 2 clinical trial evaluating OPDC-34712, Placebo, and 1 other intervention for Attention Deficit Hyperactivity Disorder. Completed, enrolled 740 participants across 35 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention Deficit Hyperactivity Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 24, 2010
Enrollment StartMar 16, 2010
Primary CompletionJun 20, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.4 years ago

Interventions

OPDC-34712drug

OPDC-34712 tablets, daily, Orally.

Placebodrug

Matching-placebo tablets, daily, Orally.

Stimulant Therapydrug

Mixed amphetamine salts or Dexmethylphenidate hydrochloride (HCL) or Methylphenidate HCl or Lisdexamfetamine dimesylate as per standard of care.