Major Depressive Disorder (MDD) MedDRA version: 17.0 Level: LLT Classification code 10025454 Term: Major depressive disorder, recurrent episode System Organ Class: 100000004873
Conditions
Interventions
Product Name: Brexpiprazole (OPC-34712)
Product Code: Brexpiprazole (OPC-34712)
Pharmaceutical Form: Tablet
INN or Proposed INN: Brexpiprazole
Current Sponsor code: OPC-34712
Concentration unit: mg mi
Sponsors
Otsuka Pharmaceutical Development & Commercialization,Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who are able to provide written informed consent and/or consent obtained from a legally acceptable representative (as required by IRB/IEC) prior to the initiation of any protocol-required procedures. 2. Ability, in the opinion of the principal investigator, to understand the nature of the trial and follow protocol requirements, including the prescribed dosage regimens, tablet/capsule ingestion, and discontinuation of prohibited concomitant medication; to read and understand the written word in order to complete subject-reported outcomes measures; and to be reliably rated on assessment scales. 3. Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent. 4. Subjects with both a diagnosis of MDD, and in a current major depressive episode, as defined by DSM-IV-TR criteria and confirmed by both the M.I.N.I. and an adequate clinical psychiatric evaluation. The current major depressive episode must be >= 8 weeks in duration. In addition, subjects must have reported a history for the current major depressive episode of an inadequate response to at least one and no more than 3 adequate antidepressant treatments. An inadequate response is defined as = 50% improvement on any antidepressant treatment in the current episode, then the subject must have had an inadequate response to a subsequent adequate antidepressant treatment (as defined above by the ATRQ) of another antidepressant drug prior to entry into the trial. For the most recent antidepressant treatment, the subject must not report >= 50% improvement (as defined above by the ATRQ). 5. Subjects with MADRS Total Score >= 26 at the Screening and Baseline visits. 6. Subjects willing to discontinue all prohibited psychotropic medications to meet protocol-required washouts prior to and during the trial period. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1714 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 71
Exclusion criteria
Exclusion criteria: For full details on exclusion criteria, please refer to Section 3.4.3 of the trial protocol. - Subjects who report an inadequate response (less than 50% reduction in depressive symptom severity) to more than 3 antidepressant treatments during the current major depressive episode at a therapeutic dose (as defined by the ATRQ) and for an adequate duration (minimum duration of 6 weeks), including any antidepressant that the subject may be taking at screening if it meets the criteria for adequate treatment. - Subjects who report treatment with adjunctive antipsychotic medication with an antidepressant for a minimum of 3 weeks during the current major depressive episode. - Subjects who have received ECT for the current major depressive episode. - Subjects who have had an inadequate response to ECT at any time in the past or who have had a vagus nerve stimulation or deep brain stimulation device implanted for management of treatmentresistant depression. -Subjects with a current need for involuntary commitment or who have been hospitalized within 4 weeks of screening for the current major depressive episode. - 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 disorder, bipolar II disorder, or bipolar disorder NOS -- Eating disorder (including anorexia nervosa or bulimia) -- Obsessive-compulsive disorder -- Panic disorder -- Posttraumatic stress disorder -Subjects with a current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder, or mental retardation. - Subjects experiencing hallucinations, delusions or any psychotic symptomatology in the current major depressive episode. -Subjects who answer “Yes” on the C-SSRS Suicidal Ideation Item 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) and whose most recent episode meeting criteria for this C-SSRS Item 4 occurred within the last 6 months, OR Subjects who answer “Yes” on the C-SSRS Suicidal Ideation Item 5 (Active Suicidal Ideation with Specific Plan and Intent) and whose most recent episode meeting criteria for this C-SSRS Item 5 occurred within the last 6 months OR Subjects who answer “Yes” on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) and whose most recent episode meeting criteria for any of these 5 C-SSRS Suicidal Behavior Items occurred within the last 2 years, OR Subjects who, in the opinion of the investigator, present a serious risk of suicide. - Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days; including alcohol and benzodiazepines, but excluding nicotine dependence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of brexpiprazole (flexible dose) with placebo as adjunctive therapy to an assigned openlabel antidepressant therapy (ADT) in the proposed subject population with MDD. ;Secondary Objective: Secondary: To evaluate the safety and tolerability of brexpiprazole (flexible dose) as adjunctive therapy to ADT in the proposed subject population with MDD.;Primary end point(s): The primary outcome endpoint for determination of efficacy is the change from randomization to endpoint in the MADRS Total Score.;Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated at the end of treatment visit according to the blinded study design. The actual week when each individual subject will have their end of treatment visit is determined by the randomization system (IWRS) in a blinded manner. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The key secondary efficacy endpoint is the change from randomization to endpoint in SDS Score (the mean of 3 individual item scores).;Timepoint(s) of evaluation of this end point: The secondary endpoint will be evaluated at the end of treatment visit according to the blinded study design. The actual week when each individual subject will have their end of treatment visit is determined by the randomization system (IWRS) in a blinded manner. | — |
Countries
Canada, France, Germany, Poland, Russian Federation, Serbia, Slovakia, Spain, Ukraine, United States
Contacts
Public ContactRegulatory Lead
INC Research
Outcome results
None listed