Study of Safety & Tolerability of OPC-34712 as Adjunctive Therapy in Treatment of Adult Patients With Major Depressive Disorder
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01447576
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