Study of the Safety and Efficacy of OPC-34712 as a Complementary Therapy in the Treatment of Adult Attention Deficit/Hyperactivity Disorder

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Treatments: Central Nervous System Stimulants

Criteria

Inclusion Criteria:

• Male and female outpatients 18 to 55 years of age, inclusive, at the time of informed consent.

• Subjects with a primary DSM-IV-TR diagnosis of ADHD (including inattentive, hyperactive, and combined subtypes) as confirmed by the CAADID. Subjects may have received prior treatment for adult ADHD, may be currently receiving treatment for adult ADHD at screening, or may be treatment-naive.

• Subjects willing to discontinue all prohibited psychotropic medication starting from the time of signing the informed consent and during the study period.

Exclusion Criteria:

• Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug.

• Subjects with an adequate response, as determined by the investigator, to any stimulant taken for the treatment of adult ADHD after 18 years of age.

• Subjects with a clinically significant current Axis II (DSM-IV-TR) diagnosis of borderline,antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder.

• Subjects who participated in a clinical trial within the last 180 days or who participated in more than two clinical trials within the past year.