The purpose of this study is to assess the long-term safety, tolerability and efficacy of oral OPC-34712 as adjunctive therapy in the treatment of adult patients with Major Depressive Disorder (MDD).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,036
Participants With Adverse Events (AEs).
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.
Time frame: After the Informed Consent Form (ICF) was signed, through Follow up 30 (+2) days after last visit
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score.
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.
Time frame: Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and 52 (last-observation-carried-forward [LOCF])
Mean Clinical Global Impression - Improvement (CGI-I) Scale Score.
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.
Time frame: Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and 52 (LOCF)
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Pacific Clinical Research Medical Group
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