Loading clinical trials...

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

COMPLETEDPHASE2

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

NCT01074294•Otsuka Pharmaceutical Development & Commercialization, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female outpatients 18 to 55 years of age, inclusive, at the time of informed consent.
•Participants with a primary diagnostic and statistical manual of mental disorders, fourth edition, text revision (DSM-IV-TR) diagnosis of ADHD (including inattentive, hyperactive, and combined subtypes) as confirmed by the Conners' Adult ADHD diagnostic interview (CAADID). Participants may have received prior treatment for adult ADHD, may be currently receiving treatment for adult ADHD at screening, or may be treatment-naive.
•Participants 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.
•Participants with an adequate response, as determined by the investigator, to any stimulant taken for the treatment of adult ADHD after 18 years of age.
•Participants with a clinically significant current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder.
•Participants who participated in a clinical trial within the last 180 days or who participated in more than two clinical trials within the past year.

Locations (35)

Little Rock, Arkansas, United States

Beverly Hills, California, United States

Irvine, California, United States

Pasadena, California, United States

San Francisco, California, United States

Bradenton, Florida, United States

Jacksonville, Florida, United States

Maitland, Florida, United States

North Miami, Florida, United States

Orlando, Florida, United States

Key Dates

Start Date

March 16, 2010

Primary Completion Date

June 20, 2011

Completion Date

June 20, 2011

Last Updated

February 2, 2023

Enrollment

740

ACTUAL participants

Conditions

Attention Deficit Hyperactivity Disorder

Interventions

OPDC-34712

DRUG

Placebo

DRUG

Stimulant Therapy

DRUG

L-theanine and Paraxanthine for Cognitive Improvement in Adults With ADHD and ASD

NCT07189442

Attention Deficit Hyperactivity Disorder (ADHD)Autism Spectrum Disorder (ASD)

View study

RECRUITINGNA

Virtual Reality in Rehabilitation of Executive Functions in Children With Attention Deficit Hyperactivity Disorder.

NCT06123741

Attention Deficit Hyperactivity Disorder

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 2, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

L-theanine and Paraxanthine for Cognitive Improvement in Adults With ADHD and ASD

Virtual Reality in Rehabilitation of Executive Functions in Children With Attention Deficit Hyperactivity Disorder.

Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure

A Dose-Response Study of the Cognitive and Physiological Effects of tDCS to the DLPFC

Effects of Probiotics on the Gut-brain Axis in Children

Characterization of Social Cognition Profiles in Children and Adolescents With Neurodevelopmental Disorders: a Clinical Study Using a Multidimensional Battery