Study of the Safety and Efficacy of OPC-34712 as a Complementary Therapy in the Treatment of Adult Attention Deficit/Hyperactivity Disorder
NCT ID: NCT01074294
Last Updated: 2023-02-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
740 participants
INTERVENTIONAL
2010-03-16
2011-06-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Phase A (Single-blind Prospective Treatment Phase): Placebo + Stimulant
Participants received single-blind matching-placebo tablets along with open-label stimulant determined by the investigator, once daily for 5 weeks. Once assigned to a stimulant by the investigator, participants remained on the same stimulant for the duration of the trial. Participants who met eligibility criteria i.e., who received prior treatment for adult ADHD and treatment-naïve participants were included in this arm group. Participants with incomplete response at the end of Phase A (Week 5) entered Phase B and rest of the participants continued to Phase A+.
Placebo
Matching-placebo tablets, daily, Orally.
Stimulant Therapy
Mixed amphetamine salts or Dexmethylphenidate hydrochloride (HCL) or Methylphenidate HCl or Lisdexamfetamine dimesylate as per standard of care.
Phase B (Double-blind Randomization Phase): Brexpiprazole + Stimulant
Participants with incomplete response (with a \> 0% and \< 30% reduction in ADHD Symptoms Total Score {18 items} between the baseline of Phase A and the end of prospective treatment { Week 5} as measured by the CAARS-O:SV { Conners' Adult ADHD Rating Scale-Observer: Screening Version}, and a CAARS-O:SV ADHD Symptoms Total Score {18 items} of ≥ 24 at Week 5, and a clinical global impression - improvement scale (CGI-I) score of 3 or 4 at Week 5) at the end of Phase A (Week 5), received Brexpiprazole 2 milligram (mg) tablet along with stimulant determined by the investigator, once daily for 6 weeks (up to Week 11).
OPDC-34712
OPDC-34712 tablets, daily, Orally.
Stimulant Therapy
Mixed amphetamine salts or Dexmethylphenidate hydrochloride (HCL) or Methylphenidate HCl or Lisdexamfetamine dimesylate as per standard of care.
Phase B (Double-blind Randomization Phase): Placebo + Stimulant
Participants with incomplete response (with a \> 0% and \< 30% reduction in ADHD Symptoms Total Score {18 items} between the Baseline of Phase A and the end of prospective treatment { Week 5} as measured by the CAARS-O:SV, and a CAARS-O:SV ADHD Symptoms Total Score {18 items} of ≥ 24 at Week 5, and a CGI-I score of 3 or 4 at Week 5) at the end of Phase A (Week 5), received matching-placebo tablets along with stimulant determined by the investigator, once daily for 6 weeks (up to Week 11).
Placebo
Matching-placebo tablets, daily, Orally.
Stimulant Therapy
Mixed amphetamine salts or Dexmethylphenidate hydrochloride (HCL) or Methylphenidate HCl or Lisdexamfetamine dimesylate as per standard of care.
Phase A+ (Single-blind Phase A Responders and Non-responders): Placebo + Stimulant
Participants with response (with a ≥ 30% reduction in ADHD Symptoms Total Score {18 items} between Baseline of Phase A and the end of prospective treatment { Week 5} as measured by the CAARS-O:SV, or a CAARS-O:SV ADHD Symptoms Total Score {18 items} of \< 24 at Week 5, or a CGI-I score of \< 3 at Week 5) and non-response (with deterioration or no change in ADHD symptoms at Week 5) at the end of Phase A (Week 5), received single-blind matching-placebo tablets along with open-label stimulant determined by the investigator, once daily for an additional 6 weeks (up to Week 11).
Placebo
Matching-placebo tablets, daily, Orally.
Stimulant Therapy
Mixed amphetamine salts or Dexmethylphenidate hydrochloride (HCL) or Methylphenidate HCl or Lisdexamfetamine dimesylate as per standard of care.
Interventions
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OPDC-34712
OPDC-34712 tablets, daily, Orally.
Placebo
Matching-placebo tablets, daily, Orally.
Stimulant Therapy
Mixed amphetamine salts or Dexmethylphenidate hydrochloride (HCL) or Methylphenidate HCl or Lisdexamfetamine dimesylate as per standard of care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Otsuka Pharmaceutical Development & Commercialization, Inc.
Locations
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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
South Miami, Florida, United States
Atlanta, Georgia, United States
Smyrna, Georgia, United States
Indianapolis, Indiana, United States
Overland Park, Kansas, United States
Rochester Hills, Michigan, United States
Saint Charles, Missouri, United States
Cherry Hill, New Jersey, United States
Willingboro, New Jersey, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Dayton, Ohio, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Memphis, Tennessee, United States
Austin, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Woodstock, Vermont, United States
Herndon, Virginia, United States
Bellevue, Washington, United States
Seattle, Washington, United States
Countries
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Other Identifiers
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331-08-213
Identifier Type: -
Identifier Source: org_study_id
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