Study of Safety & Tolerability of OPC-34712 as Adjunctive Therapy in Treatment of Adult Patients With Major Depressive Disorder
|ClinicalTrials.gov Identifier: NCT01447576|
Recruitment Status : Completed
First Posted : October 6, 2011
Results First Posted : November 6, 2015
Last Update Posted : November 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: ADT Drug: OPC-34712||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1036 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Multicenter, Open-label Study to Assess the Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adult Patients With Major Depressive Disorder|
|Study Start Date :||September 2009|
|Primary Completion Date :||December 2012|
|Study Completion Date :||December 2012|
Experimental: OPC-34712 + ADT
Experimental: OPC-34712, Oral Tablets, 0.25 - 3 mg; Antidepressant drug treatment
Once daily dosing during the duration of the study.
Other Name: Anti-depressant Drug TherapyDrug: OPC-34712
OPC-34712, Oral Tablets, 0.25 - 3 mg
- Participants With Adverse Events (AEs). [ Time Frame: After the Informed Consent Form (ICF) was signed, through Follow up 30 (+2) days after last visit ]An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug-related by the physician. The severity was assessed as mild, moderate, or severe. A treament-emergent AE (TEAE) was defined as any AE that started after start of open-label brexpiprazole; or if the event was continuous from baseline and was worsening, serious, study drug-related, or resulted in death, discontinuation, interruption, or reduction of study drug.
- Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score. [ Time Frame: Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and 52 (last-observation-carried-forward [LOCF]) ]The CGI-S is a 7-point scale from 1 through 7. The items on CGI-S scale are: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill participants. The score 0 (= not assessed) was set to missing.
- Mean Clinical Global Impression - Improvement (CGI-I) Scale Score. [ Time Frame: Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and 52 (LOCF) ]The items on CGI-I scale are 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. The score of 0 (= not assessed) was set to missing. The CGI-I is therefore a 7-point scale from 1 through 7. CGI improvement was compared to the participants condition at Baseline.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01447576
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