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

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01074294

Collaborator

(none)

740

Enrollment

Locations

Arms

Duration (Months)

21.1

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Hyperactivity Disorder	Drug: OPDC-34712 + Stimulant Therapy Drug: Placebo + Stimulant Therapy	Phase 2

Detailed Description

Subjects who have been taking prescription medication for ADHD, may be switched to a different one. In addition, subjects will be randomly (by chance) assigned to the investigational medication or placebo (pill without active medication). Total study participation lasts 6-20 weeks (up to 5 months). 675 men and women will be in the study at 40 study centers throughout the U.S.

Study Design

Study Type:

Interventional

Actual Enrollment :

740 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2010

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Sugar pill	Drug: Placebo + Stimulant Therapy Placebo plus a FDA approved stimulant therapy
Experimental: OPC-34712	Drug: OPDC-34712 + Stimulant Therapy Tablets, Oral, 0.25 or 1.0 mg OPDC-34712 and FDA approved stimulant therapy

Arm

Intervention/Treatment

Placebo Comparator: Sugar pill

Drug: Placebo + Stimulant Therapy

Placebo plus a FDA approved stimulant therapy

Experimental: OPC-34712

Drug: OPDC-34712 + Stimulant Therapy

Tablets, Oral, 0.25 or 1.0 mg OPDC-34712 and FDA approved stimulant therapy

Outcome Measures

Primary Outcome Measures

To assess the efficacy of adjunctive OPC-34712 (0.25 to 2 mg/day) compared to placebo in adults with ADHD who are identified as incomplete responders to stimulant therapy.To assess the tolerability/safety of adjunctive OPC-34712. [11 weeks]

Secondary Outcome Measures

To assess the effect of adjunctive OPC-34712 (0.25 to 2 mg/day) compared to placebo on sleep, neurocognitive function, and health outcomes in adults with ADHD who are prospectively identified as incomplete/partial responders to stimulant therapy. [11 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Little Rock	Arkansas	United States
2	Beverly Hills	California	United States
3	Irvine	California	United States	92612
4	Pasadena	California	United States
5	San Francisco	California	United States
6	Bradenton	Florida	United States
7	Jacksonville	Florida	United States
8	Maitland	Florida	United States
9	North Miami	Florida	United States
10	Orlando	Florida	United States
11	South Miami	Florida	United States	33173
12	Atlanta	Georgia	United States
13	Smyrna	Georgia	United States
14	Indianapolis	Indiana	United States
15	Overland Park	Kansas	United States
16	Rochester Hills	Michigan	United States
17	St. Charles	Missouri	United States
18	Cherry Hill	New Jersey	United States
19	Willingboro	New Jersey	United States
20	New York	New York	United States
21	Chapel Hill	North Carolina	United States
22	Durham	North Carolina	United States
23	Cincinnati	Ohio	United States
24	Dayton	Ohio	United States
25	Oklahoma City	Oklahoma	United States
26	Portland	Oregon	United States
27	Philadelphia	Pennsylvania	United States
28	Memphis	Tennessee	United States
29	Austin	Texas	United States
30	Houston	Texas	United States
31	Salt Lake City	Utah	United States
32	Woodstock	Vermont	United States
33	Herndon	Virginia	United States
34	Bellevue	Washington	United States
35	Seattle	Washington	United States