Major depressive disorder (MDD) MedDRA version: 21.1 Level: LLT Classification code 10025454 Term: Major depressive disorder, recurrent episode System Organ Class: 100000004873
Conditions
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Key inclusion criteria include the following: - Subjects with both a diagnosis of recurrent MDD, and in a current major depressive episode of = 8 weeks in duration, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5) criteria and confirmed by both the MINI and an adequate clinical psychiatric evaluation. - Subjects must have reported a history for the current major depressive episode of an inadequate response to 1 or 2 adequate antidepressant treatments, and subjects must currently be taking a protocol-mandated antidepressant treatment at an adequate dose and duration, and must not have reported = 50% improvement (as defined by the ATRQ). For subjects who are currently on an adequate dose of a protocol mandated ADT but for an inadequate duration, the screening period may be used to achieve adequate duration. At Phase A baseline, all subjects must have either 2 or 3 documented inadequate responses to antidepressant treatment for the current episode as defined by the ATRQ. - Subjects with a 17-item Hamilton Depression Rating Scale (HAM-D17) total score = 18 at the screening and Phase A baseline visits. For the complete list of inclusion criteria please refer to the clinical study protocol. 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 1160 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 290
Exclusion criteria
Exclusion criteria: Key exclusion criteria include the following: Subjects with a primary DSM-5 diagnosis of: - Schizophrenia Spectrum and Other Psychotic Disorders; - Bipolar and Related Disorders; - Obsessive compulsive disorder - Feeding and Eating Disorders (including anorexia nervosa or bulimia); - Neurocognitive disorders (including but not limited to: Delirium, Major or Mild Neurocognitive Disorder due to: Alzheimer’s, Parkinson’s, Traumatic Brain Injury); - Panic disorder; - Post-traumatic stress disorder; Subjects with a current DSM-5 diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder or intellectual disability. For the complete list of exclusion criteria please refer to the clinical study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of brexpiprazole (2 to 3 mg/day) to placebo as adjunctive therapy to antidepressant therapy (ADT) for the maintenance treatment in adults with major depressive disorder (MDD). ;Secondary Objective: To evaluate the safety and tolerability of brexpiprazole (2 to 3 mg/day) as adjunctive therapy to ADT in the proposed subject population with MDD. ;Primary end point(s): The primary endpoint is time-to-relapse by any criteria as defined in the blinded addendum to this protocol.;Timepoint(s) of evaluation of this end point: From Week 20 (randomization) into the Double-blind, Randomized Withdrawal Treatment Phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key Secondary Endpoints: - Change from randomization in the SDS mean total score at Week 46 - Time-to-functional relapse based on SDS criteria;Timepoint(s) of evaluation of this end point: Please refer to the schedule of assessments in the protocol. | — |
Countries
Germany, Poland, United States
Contacts
Public ContactCorey Fowler
Otsuka Pharmaceutical Development & Commercialization, Inc.
Outcome results
None listed