Clinical trial NCT02013531: Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Adults With Major Depressive Disorder and Anxiety Symptoms
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Anxiety
Keywords: schizophrenia
Major depressive disorder
Anxiety Symptoms
Mental Disorders
Psychotic Disorders
emotional withdrawal
antipsychotic
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2013-12-17
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Mean Change in Clinical Global Impression-Severity (CGI-S) Total Score
timeFrame: Baseline, Week 6
measure: Mean Clinical Global Impression-Improvement (CGI-I) Score at Week 6.
timeFrame: Baseline, Week 6
measure: Percentage of Participants With CGI-I Response Rate
timeFrame: Week 1 to Week 6
measure: Percentage of Participants With a MADRS Response
timeFrame: Week 6
measure: Percentage of Participants With a MADRS Remission
timeFrame: Week 6
measure: Mean Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score
timeFrame: Baseline, Week 6
measure: Mean Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score
timeFrame: Baseline, Week 6
measure: Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Score
timeFrame: Baseline, Week 6
measure: Mean Change From Baseline in Massachusetts General Hospital-Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total Score
timeFrame: Baseline, Week 6
measure: Mean Change From Baseline in Kellner Symptom Questionnaire (KSQ)
timeFrame: Baseline, Week 6
measure: Mean Change From Baseline in Go/No-Go Task for P-inhibition Failures
timeFrame: Baseline, Week 6
measure: Mean Change From Baseline in Go/No-Go Task for Mean Reaction Time
timeFrame: Baseline, Week 6
measure: Mean Change From Baseline in Delay Discounting Task - Monetary Choice Questionnaire (MCQ) Score
timeFrame: Baseline, Week 6
measure: Mean Change From Baseline in Delay and Probability Discounting Task (DPDT) Scores
timeFrame: Baseline, Week 6
measure: Mean Change From Baseline to Week 6 in the Number of Impulsive Choices in the Delayed Reward Task (DRT)
timeFrame: Baseline, Week 6
measure: Mean Change From Baseline in Food Delay Discounting Task
timeFrame: Baseline, Week 6
measure: Mean Change From Baseline in Money Delay Discounting Task
timeFrame: Baseline, Week 6
measure: Mean Change From Baseline in Barratt Impulsiveness Scale 11-item (BIS-11) Total Score
timeFrame: Baseline, Week 6
Other outcomes:
Locations:
city: Tuscon
country: United States
state: Arizona
city: Garden Grove
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Temecula
country: United States
state: California
city: Gainesville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Lafayette
country: United States
state: Indiana
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Haverhill
country: United States
state: Massachusetts
city: Rochester Hills
country: United States
state: Michigan
city: New York
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Salem
country: United States
state: Oregon
city: Allentown
country: United States
state: Pennsylvania
city: Arlington
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Woodstock
country: United States
state: Vermont
city: Richmond
country: United States
state: Virginia
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd Japan (OPCJ)
name: Junichi Hashimoto, PhD
role: STUDY_DIRECTOR
References:
citation: Weiss C, Meehan SR, Brown TM, Gupta C, Morup MF, Thase ME, McIntyre RS, Ismail Z. Effects of adjunctive brexpiprazole on calmness and life engagement in major depressive disorder: post hoc analysis of patient-reported outcomes from clinical trial exit interviews. J Patient Rep Outcomes. 2021 Dec 11;5(1):128. doi: 10.1186/s41687-021-00380-4.
citation: Davis LL, Ota A, Perry P, Tsuneyoshi K, Weiller E, Baker RA. Adjunctive brexpiprazole in patients with major depressive disorder and anxiety symptoms: an exploratory study. Brain Behav. 2016 Jul 24;6(10):e00520. doi: 10.1002/brb3.520. eCollection 2016 Oct.