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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 1,036
- Locations
- 32
- Primary Endpoint
- Participants With Adverse Events (AEs).
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female subjects between 18 and 65 years of age, with a diagnosis of a single or recurrent, non-psychotic episode of major depressive disorder, as defined by DSM-IV-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I.) which is equal to or greater than 8 weeks in duration.
- •Subjects must currently be taking allowable antidepressant therapy at an adequate dose for a minimum of six weeks by the end of the screening period (ie at the time of the Baseline visit).
- •Subjects must report a history for the current depressive episode of an inadequate response to at least one and no more than four adequate antidepressant treatments.
Exclusion Criteria
- •Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug.
- •Subjects who report an inadequate response to more than three adequate trials of antidepressant treatments during current depressive episode at a therapeutic dose for an adequate duration.
- •Subjects with a current Axis I (DSM-IV-TR) diagnosis of: Delirium, dementia,amnestic or other cognitive disorder Schizophrenia, schizoaffective disorder, or other psychotic disorder Bipolar I or II disorder, eating disorder (including anorexia nervosa or bulimia), obsessive compulsive disorder, panic disorder, post-traumatic stress disorder.
- •Subjects with a clinically significant current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.
Arms & Interventions
OPC-34712 + ADT
Experimental: OPC-34712, Oral Tablets, 0.25 - 3 mg; Antidepressant drug treatment
Intervention: ADT (Drug)
OPC-34712 + ADT
Experimental: OPC-34712, Oral Tablets, 0.25 - 3 mg; Antidepressant drug treatment
Intervention: OPC-34712 (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score.(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.(Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and 52 (LOCF))