Phase 2 N=740 Randomized Double-blind Treatment

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

Attention Deficit Hyperactivity Disorder

Bottom Line

View on ClinicalTrials.gov: NCT01074294 ↗

Enrolled (actual)

740

Serious AEs

0.2%

Results posted

Feb 2023

Primary outcome: Primary: Mean Change From Baseline (End of Phase A) in the CAARS-O:SV ADHD Symptoms Total Score (18 Items) to End of Phase B — -9.02; -9.71 score on a scale — p=0.5845

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: OPDC-34712 (Drug); Placebo (Drug); Stimulant Therapy (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Primary completion: Jun 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline (End of Phase A) in the CAARS-O:SV ADHD Symptoms Total Score (18 Items) to End of Phase B	-9.02; -9.71	0.5845
SECONDARY Change From Baseline (End of Phase A) in Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) Total Score to End of Phase B	-3.93; -3.84	0.8832
SECONDARY Change From Baseline (End of Phase A) in Sleep Improvement Measured by Insomnia Severity Index (ISI) Total Score to End of Phase B	-1.05; -1.62	0.3864
SECONDARY 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	-0.04; -0.37	0.0061 sig
SECONDARY 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	0.10; -0.31	0.6932
SECONDARY 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	-3.82; -4.62; -5.54; -6.21; -6.37; -6.99	0.2781
SECONDARY Change From Baseline (End of Phase A) in CAARS-O:SV Inattentive Symptoms Subscale Score (9 Items) to Each Time Point in Phase B	-2.00; -2.43; -2.94; -3.20; -3.14; -3.42	0.3804
SECONDARY 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	-1.88; -2.11; -2.66; -2.94; -3.29; -3.48	0.6008
SECONDARY Change From Baseline (End of Phase A) in CAARS-O:SV ADHD Index Score (12 Items) to Each Time Point in Phase B	-2.06; -2.20; -3.47; -3.38; -4.01; -3.80	0.7881
SECONDARY Change From Baseline (End of Phase A) to Weeks 7 and 9 in ISI Total Score	-0.81; -0.83; -0.99; -1.48	0.9708
SECONDARY 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	33.6; 32.4; 33.3; 37.7; 35.3; 39.0	0.9568
SECONDARY 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	-1.75; -2.16; -3.01; -3.47; -4.15; -4.08	0.6357
SECONDARY Change From Baseline (End of Phase A) in CAARS-S:SV Inattentive Symptoms Subscale Score (9 Items) to Each Timepoint in Phase B	-0.87; -1.16; -1.64; -1.62; -2.08; -1.93	0.5647
SECONDARY Change From Baseline (End of Phase A) in CAARS-S:SV Hyperactive/Impulsive Symptoms Subscale Score (9 Items) to Each Timepoint in Phase B	-0.91; -1.06; -1.38; -1.88; -2.09; -2.20	0.7556
SECONDARY Change From Baseline (End of Phase A) in CAARS-S:SV ADHD Index Score (12 Items) to Each Timepoint in Phase B	-1.09; -1.16; -1.86; -2.13; -2.69; -2.43	0.8986
SECONDARY Change From Baseline (End of Phase A) in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score to Each Timepoint in Phase B	-0.75; -0.71; -0.92; -0.88; -1.03; -0.97	0.6976
SECONDARY 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	0.15; -0.12	0.4089
SECONDARY 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	0.00; 0.30	0.2331
SECONDARY 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	0.00; 0.01	0.0670
SECONDARY Change From Baseline (End of Phase A) in the RVP Median Response Latency Score as Measured by CANTAB to End of Phase B	-17.1; -2.89	0.0849
SECONDARY Change From Baseline (End of Phase A) in RVP Total False Alarms Score as Measured by CANTAB to End of Phase B	0.12; 0.58	0.7663
SECONDARY 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	13.41; -4.10	0.0298 sig
SECONDARY Change From Baseline (End of Phase A) in the SST Proportion of Successful Stops Score as Measured by CANTAB to End of Phase B	-0.01; 0.01	0.2563
SECONDARY 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	-6.70; -1.03	0.6644
SECONDARY Change From Baseline (End of Phase A) in WRAADDS Attention + Organization Subscale Score to End of Phase B	-1.47; -1.42	0.8418
SECONDARY 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	-1.27; -1.01	0.2513
SECONDARY Change From Baseline (End of Phase A) in WRAADDS Temper + Mood Lability + Emotional Over-reactivity Subscale Score to End of Phase B	-1.24; -1.35	0.7037
SECONDARY Mean CGI-I Score at Each Timepoint in Phase B	3.19; 3.12; 3.04; 3.08; 2.93; 2.88	0.7572
SECONDARY Percentage of Participants With CAARS-O:SV ADHD Symptoms Response Rate in Phase B	15.0; 12.8; 24.2; 24.4; 28.8; 33.3	0.6014
SECONDARY Percentage of Participants With CAARS-O:SV ADHD Symptoms Remission Rate in Phase B	7.19; 6.41; 12.4; 12.8; 19.0; 19.2	0.8586
SECONDARY Percentage of Participants With CAARS-S:SV ADHD Symptoms Response Rate in Phase B	11.8; 12.8; 18.3; 15.4; 21.6; 21.8	0.9577
SECONDARY Percentage of Participants With CAARS-S:SV ADHD Symptoms Remission Rate in Phase B	8.50; 7.69; 12.4; 12.8; 15.7; 15.4	0.7232
SECONDARY Percentage of Participants With CGI-I Response Rate in Phase B	18.3; 15.4; 23.5; 17.9; 31.4; 30.8	0.3631

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01074294). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.