A Study of Brexpiprazole in Patients With Major Depressive Disorder

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess the safety and efficacy of brexipiprazole to placebo as adjunctive treatment to an assigned open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Treatments: Brexpiprazole

Criteria

Inclusion Criteria:

• Outpatients, or inpatients at the time of informed consent whose treatment status can be successfully shifted to outpatient status before enrollment in the antidepressant treatment period

• Male and female patients ≥ 20 to < 65 years of age (at the time of informed consent)

• Patients who have a level of comprehension sufficient to allow them to give written informed consent to all of the observation/examination/evaluation items specified in the protocol, and who can understand the contents of the trial

• Patients with a DSM-5 classification-based diagnosis of "major depressive disorder, single episode" or "major depressive disorder, recurrent episode," and whose current episode has persisted for at least 8 weeks

Exclusion Criteria:

• Women who are pregnant or breastfeeding or who have positive pregnancy test (urine) results at screening

• Sexually active male subjects or sexually active female subjects of childbearing potential, who will not agree to practice 2 different methods of birth control or to remain abstinent during the trial and for 30 days after the final

IMP administration. For birth control, 2 of the following methods must be used:

vasectomy, tubal ligation, vaginal diaphragm, intra-uterine contraceptive device (IUD), oral contraceptives, or condom with spermicide.

• Patients with a treatment history showing that all antidepressants (including those not used for the current major depressive episode) cannot be tolerated

• Patients with a history of electroconvulsive therapy

• Patients with a diagnosis of any of the following diseases according to DSM-5

1. Neurocognitive disorders

2. Schizophrenia spectrum and other psychotic disorders

3. Bipolar and related disorders

4. Feeding and eating disorders

5. Obsessive-compulsive disorder

6. Panic disorder

7. Posttraumatic stress disorder