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



Status:Completed
Conditions:Anxiety, Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:November 2013
End Date:June 2014

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Protocol 331-13-002: An Exploratory, Multicenter, Open-label, Flexible-dose Trial of Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Adults With Major Depressive Disorder and Anxiety Symptoms

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.


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.
We found this trial at
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