Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Adults With Major Depressive Disorder and Anxiety Symptoms

Otsuka

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder; Anxiety

Treatments: Drug: Brexpiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT02013531

331-13-002

Details and patient eligibility

About

The purpose of this study is to investigate the efficacy and safety of flexibly dosed adjunctive brexpiprazole treatment in subjects with major depressive disorder and anxiety symptoms, who are experiencing an inadequate selective serotonin reuptake inhibitor (SSRI)/serotonin norepinephrine reuptake inhibitor (SNRI) response.

Enrollment: 37 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Have a diagnosis of a single or recurrent, nonpsychotic episode of MDD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and confirmed by both the Mini International Neuropsychiatric Interview (M.I.N.I.) and an adequate clinical psychiatric evaluation.

• Have a treatment history of an inadequate ADT response to at least 1 ADT (but not > 3) for the current episode.

• Have received a single, trial-approved, SSRI or SNRI at an adequate dose for

  ≥ 6 weeks prior to screening.

• Are 18 to 65 years old at the time of consent (inclusive, and outpatients only).

• Have a Hamilton Depression Rating Scale (HAM-D)-17-item Total Score ≥ 18 at screening and baseline.

• Have a Hamilton Anxiety Rating Scale (HAM-A) Total Score ≥ 20 at screening and baseline.

Main Exclusion Criteria:

Subjects with any of the following current Axis I DSM-IV-TR diagnoses:

• delirium
• dementia
• amnestic
• other cognitive disorders
• schizophrenia
• schizoaffective disorder
• other psychotic disorders
• bipolar I disorder,
• bipolar II disorder
• bipolar disorder not otherwise specified (NOS)
• eating disorders
• anorexia nervosa
• bulimia
• obsessive compulsive disorder
• post-traumatic stress disorder

Subjects with any of the following current Axis II DSM-IV-TR diagnoses:

• borderline, antisocial
• paranoid
• schizoid
• schizotypal
• histrionic personality disorders
• mental retardation.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

Brexpiprazole

Experimental group

Description:

Up to 3 mg/day, once daily dose, tablets, orally

Treatment:

Drug: Brexpiprazole