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

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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)

37 participants in 1 patient group

Brexpiprazole
Experimental group
Description:
Up to 3 mg/day, once daily dose, tablets, orally
Treatment:
Drug: Brexpiprazole

Trial contacts and locations

21

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Data sourced from clinicaltrials.gov

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