NCT01074294

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, 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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 740 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	OPDC-34712	OPDC-34712 tablets, daily, Orally.
DRUG	Placebo	Matching-placebo tablets, daily, Orally.
DRUG	Stimulant Therapy	Mixed amphetamine salts or Dexmethylphenidate hydrochloride (HCL) or Methylphenidate HCl or Lisdexamfetamine dimesylate as per standard of care.

Timeline

• Start date: 2010-03-16
• Primary completion: 2011-06-20
• Completion: 2011-06-20
• First posted: 2010-02-24
• Last updated: 2023-02-02
• Results posted: 2023-02-02

Locations

35 sites across 1 country: United States

Regulatory

• FDA-regulated drug study