Study of Safety & Tolerability of OPC-34712 as Adjunctive Therapy in Treatment of Adult Patients With Major Depressive Disorder

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: ADT
* Drug: OPC-34712


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OPC-34712 + ADT<br>Experimental: OPC-34712, Oral Tablets, 0.25 - 3 mg; Antidepressant drug treatment | Drug: ADT<br>* Once daily dosing during the duration of the study.<br>* Other names: Anti-depressant Drug Therapy;Drug: OPC-34712<br>* OPC-34712, Oral Tablets, 0.25 - 3 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | After the Informed Consent Form (ICF) was signed, through Follow up 30 (+2) days after last visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and 52 (LOCF) |