A Phase 3 Trial Investigating the Safety, Tolerability and Effectiveness of additional treatment with Brexpiprazole in the Treatment of Adults with Major Depressive Disorder
- Conditions
- Major depressive disorder (MDD)MedDRA version: 21.1Level: LLTClassification code 10025454Term: Major depressive disorder, recurrent episodeSystem Organ Class: 100000004873Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2018-000601-22-DE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 1448
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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).<br>;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.<br>;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 Outcome Measures
Name Time Method Secondary end point(s): Key Secondary Endpoints:<br>- Change from randomization in the SDS mean total score at Week 46<br>- 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.