Clinical trial NCT01074294: Study of the Safety and Efficacy of OPC-34712 as a Complementary Therapy in the Treatment of Adult Attention Deficit/Hyperactivity Disorder
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Inattention
Hyperactivity
Impulsivity
Distractibility
Procrastination
Disorganized
ADHD
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2010-02-24
Enrollment: 740
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean Change From Baseline (End of Phase A) in the CAARS-O:SV ADHD Symptoms Total Score (18 Items) to End of Phase B
timeFrame: Baseline [end of Phase A (Week 5)] to Week 11
Secondary outcomes:
measure: Change From Baseline (End of Phase A) in Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) Total Score to End of Phase B
timeFrame: Baseline [end of Phase A (Week 5)] to Week 11
measure: Change From Baseline (End of Phase A) in Sleep Improvement Measured by Insomnia Severity Index (ISI) Total Score to End of Phase B
timeFrame: Baseline [end of Phase A (Week 5)] to Week 11
measure: Change From Baseline (End of Phase A) in Sleep Improvement Measured by ISI for Item 2 Score (Difficulty Staying Asleep) to End of Phase B
timeFrame: Baseline [end of Phase A (Week 5)] to Week 11
measure: Change From Baseline (End of Phase A) in the Spatial Working Memory (SWM) Between Errors 4-8 Boxes Test Score as Measured by Cambridge Neuropsychological Test Automated Battery (CANTAB) to End of Phase B
timeFrame: Baseline [end of Phase A (Week 5)] to Week 11
measure: Change From Baseline (End of Phase A) in CAARS-O:SV ADHD Symptoms Total Score (18 Items) to Each Time Point in Phase B Other Than Week 11
timeFrame: Baseline [end of Phase A (Week 5)] to Weeks 6, 7, 8, 9 and 10
measure: Change From Baseline (End of Phase A) in CAARS-O:SV Inattentive Symptoms Subscale Score (9 Items) to Each Time Point in Phase B
timeFrame: Baseline [end of Phase A (Week 5)]; Weeks 6, 7, 8, 9, 10 and 11
measure: Change From Baseline (End of Phase A) in CAARS-O:SV Hyperactive/Impulsive Symptoms Subscale Score (9 Items) to Each Time Point in Phase B
timeFrame: Baseline [end of Phase A (Week 5)]; Weeks 6, 7, 8, 9, 10 and 11
measure: Change From Baseline (End of Phase A) in CAARS-O:SV ADHD Index Score (12 Items) to Each Time Point in Phase B
timeFrame: Baseline [end of Phase A (Week 5)]; Weeks 6, 7, 8, 9, 10 and 11
measure: Change From Baseline (End of Phase A) to Weeks 7 and 9 in ISI Total Score
timeFrame: Baseline [end of Phase A (Week 5)]; Weeks 7 and 9
measure: Percentage of Participants With Categorical Change in Sleep Improvement Measured by Individual Scores for Items 1, 2, and 3 of the ISI at End of Phase B
timeFrame: Baseline [(end of Phase A (Week 5)] to Weeks 7, 9 and 11
measure: Change From Baseline (End of Phase A) in Conners' Adult ADHD Rating Scale-Self-Report: Screening Version (CAARS-S:SV) ADHD Symptoms Total Score (18 Items) to Each Timepoint in Phase B
timeFrame: Baseline [end of Phase A (Week 5)]; Weeks 6, 7, 8, 9, 10 and 11
measure: Change From Baseline (End of Phase A) in CAARS-S:SV Inattentive Symptoms Subscale Score (9 Items) to Each Timepoint in Phase B
timeFrame: Baseline [end of Phase A (Week 5)]; Weeks 6, 7, 8, 9, 10 and 11
measure: Change From Baseline (End of Phase A) in CAARS-S:SV Hyperactive/Impulsive Symptoms Subscale Score (9 Items) to Each Timepoint in Phase B
timeFrame: Baseline [end of Phase A (Week 5)]; Weeks 6, 7, 8, 9, 10 and 11
measure: Change From Baseline (End of Phase A) in CAARS-S:SV ADHD Index Score (12 Items) to Each Timepoint in Phase B
timeFrame: Baseline [end of Phase A (Week 5)]; Weeks 6, 7, 8, 9, 10 and 11
measure: Change From Baseline (End of Phase A) in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score to Each Timepoint in Phase B
timeFrame: Baseline [end of Phase A (Week 5)]; Weeks 6, 7, 8, 9, 10 and 11
measure: Change From Baseline (End of Phase A) in the SWM Strategy 6-8 Boxes Test Score as Measured by CANTAB to End of Phase B
timeFrame: Baseline [end of Phase A (Week 5)] to Week 11
measure: Change From Baseline (End of Phase A) in the SWM Within Errors 4-8 Boxes Test Score as Measured by CANTAB to End of Phase B
timeFrame: Baseline [end of Phase A (Week 5)] to Week 11
measure: Change From Baseline (End of Phase A) in the Rapid Visual Information Processing (RVP) A Prime Test Score as Measured by CANTAB to End of Phase B
timeFrame: Baseline [end of Phase A (Week 5)] to Week 11
measure: Change From Baseline (End of Phase A) in the RVP Median Response Latency Score as Measured by CANTAB to End of Phase B
timeFrame: Baseline [end of Phase A (Week 5)] to Week 11
measure: Change From Baseline (End of Phase A) in RVP Total False Alarms Score as Measured by CANTAB to End of Phase B
timeFrame: Baseline [end of Phase A (Week 5)] to Week 11
measure: Change From Baseline (End of Phase A) in the Stop Signal Task (SST) Stop Signal Reaction Time (SSRT) Score as Measured by CANTAB to End of Phase B
timeFrame: Baseline [end of Phase A (Week 5)] to Week 11
measure: Change From Baseline (End of Phase A) in the SST Proportion of Successful Stops Score as Measured by CANTAB to End of Phase B
timeFrame: Baseline [end of Phase A (Week 5)] to Week 11
measure: Change From Baseline (End of Phase A) in SST Median Reaction Time Score on Go Trials as Measured by CANTAB to End of Phase B
timeFrame: Baseline [end of Phase A (Week 5)] to Week 11
measure: Change From Baseline (End of Phase A) in WRAADDS Attention + Organization Subscale Score to End of Phase B
timeFrame: Baseline [end of Phase A (Week 5)] to Week 11
measure: Change From End of Phase A (Week 5 Visit) to End of Phase B (Week 11 Visit) in WRAADDS Hyperactivity + Impulsivity Subscale Score to End of Phase B
timeFrame: Baseline [end of Phase A (Week 5)] to Week 11
measure: Change From Baseline (End of Phase A) in WRAADDS Temper + Mood Lability + Emotional Over-reactivity Subscale Score to End of Phase B
timeFrame: Baseline [end of Phase A (Week 5)] to Week 11
measure: Mean CGI-I Score at Each Timepoint in Phase B
timeFrame: Weeks 6, 7, 8, 9, 10 and 11
measure: Percentage of Participants With CAARS-O:SV ADHD Symptoms Response Rate in Phase B
timeFrame: Weeks 6, 7, 8, 9, 10 and 11
measure: Percentage of Participants With CAARS-O:SV ADHD Symptoms Remission Rate in Phase B
timeFrame: Weeks 6, 7, 8, 9, 10 and 11
measure: Percentage of Participants With CAARS-S:SV ADHD Symptoms Response Rate in Phase B
timeFrame: Weeks 6, 7, 8, 9, 10 and 11
measure: Percentage of Participants With CAARS-S:SV ADHD Symptoms Remission Rate in Phase B
timeFrame: Weeks 6, 7, 8, 9, 10 and 11
measure: Percentage of Participants With CGI-I Response Rate in Phase B
timeFrame: Weeks 6, 7, 8, 9, 10 and 11
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Beverly Hills
country: United States
state: California
city: Irvine
country: United States
state: California
city: Pasadena
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Bradenton
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Maitland
country: United States
state: Florida
city: North Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Smyrna
country: United States
state: Georgia
city: Indianapolis
country: United States
state: Indiana
city: Overland Park
country: United States
state: Kansas
city: Rochester Hills
country: United States
state: Michigan
city: Saint Charles
country: United States
state: Missouri
city: Cherry Hill
country: United States
state: New Jersey
city: Willingboro
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Memphis
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Woodstock
country: United States
state: Vermont
city: Herndon
country: United States
state: Virginia
city: Bellevue
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc.
name: Study Director
role: STUDY_DIRECTOR
References: