A Study of Brexpiprazole in Patients With Major Depressive Disorder

Otsuka

Status and phase: Completed; Phase 3; Phase 2

Conditions: Major Depressive Disorder

Treatments: Drug: Brexpiprazole; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03697603

331-102-00058

Details and patient eligibility

About

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.

Enrollment: 740 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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740 participants in 3 patient groups, including a placebo group

Brexpiprazole 1mg

Experimental group

Description:

Tablets, Oral, 1mg once daily, 14 weeks Other Name: REXULTI

Treatment:

Drug: Brexpiprazole

Brexpiprazole 2mg

Experimental group

Description:

Tablets, Oral, 2 mg once daily, 14 weeks Other Name: REXULTI

Treatment:

Drug: Brexpiprazole

Placebo

Placebo Comparator group

Description:

Tablets, Oral, once daily, 14 weeks

Treatment:

Drug: Placebo