Clinical trial NCT02013609: Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Active Adults, 18 to 35 Years Old, With Major Depressive Disorder Who Are in a School or Work Environment
Official title: Protocol 331-13-003: An Exploratory, Multicenter, Open-label, Flexible-dose Trial of Brexpiprazole (OPC 34712) as an Adjunctive Treatment in Active Adults, 18 to 35 Years Old, With Major Depressive Disorder Who Are in a School or Work Environment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: MDD
Keywords: schizophrenia
Major depressive disorder
Anxiety Symptoms
School, Work environment
Mental Disorders
Psychotic Disorders
antipsychotic
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2013-12-17
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy and safety of flexibly dosed adjunctive brexpiprazole treatment in active adults with MDD, 18 to 35 years old, who are experiencing an inadequate selective serotonin reuptake inhibitor (SSRI)/serotonin norepinephrine reuptake inhibitor (SNRI) response in a school or work environment.


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 35 years old at the time of consent (inclusive, and outpatients only).

Are (and will be) working 20 hours or more per week or a student taking 6 credit hours or more during the trial period, however minor deviations from the "part-time" concept may be acceptable on a case-by-case basis based on approval of the medical monitor.

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

Have a Sheehan Disability Scale (SDS) 3-item mean score ≥ 5 at baseline.

Main Exclusion Criteria:

Subjects with any of the following current Axis I DSM-IV-TR diagnoses: delirium, dementia, amnestic, or other cognitive disorders; schizophrenia, schizoaffective disorder, or other psychotic disorders; bipolar I disorder, bipolar II disorder, or bipolar disorder not otherwise specified (NOS); eating disorders (including anorexia nervosa or bulimia); obsessive compulsive disorder; panic disorder; post-traumatic stress disorder; and attention deficit hyperactivity disorder.

Subjects with any of the following current Axis II DSM-IV-TR diagnoses: borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorders, or mental retardation.

Primary outcomes:
measure: Mean Change From Baseline to Week 12 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Mean Change From Baseline to Week 12 in Clinical Global Impression-Severity (CGI-S) Total Score
timeFrame: Baseline and Week 12
measure: Mean Clinical Global Impression-Improvement (CGI-I) Score at Week 12
timeFrame: Weeks 1, 2, 3, 4, 5, 6, 8, 10 and 12
measure: Number of Participants With CGI-I Response
timeFrame: Weeks 1, 2, 3, 4, 6, 8 ,10 and 12
measure: Percentage of Participants With MADRS Response
timeFrame: Baseline and Week 12
measure: Percentage of Participants With MADRS Remission
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline to Week 12 in Hamilton Depression Rating Scale (HAM-D17) Total Score
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline to Week 12 in Sheehan Disability Scale (SDS) 3-item Total/Summed Score
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline to Week 12 in Sheehan Disability Scale (SDS) Single Item Sub-scores
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline to Week 12 in Social Adaptation Self-evaluation Scale (SASS) Total Score
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline to Week 12 in Massachusetts General Hospital-Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total Score
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline to Week 12 in Kellner Symptom Questionnaire (KSQ) Total Score
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline to Week 12 in Go/No-Go Task (P-inhibition Failure)
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline to Week 12 in Go/No-Go Task (Mean Reaction Time)
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline in Delay Discounting Task - Monetary Choice Questionnaire (MCQ) k Value
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline to Week 12 in the Number of Impulsive Choices in the Delayed Reward Task (DRT)
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline to Week 12 in Delay and Probability Discounting Task (DPDT)
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline in Food Delay Discounting Task (DDT)
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline in Money Delay Discounting Task
timeFrame: Baseline and Week 12
measure: Mean Change From Baseline to Week 12 in Barratt Impulsiveness Scale 11-Item (BIS-11) Total Score
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Cerritos
country: United States
state: California
city: Costa Mesa
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Glendale
country: United States
state: California
city: Orange
country: United States
state: California
city: Riverside
country: United States
state: California
city: San Diego
country: United States
state: California
city: Norwich
country: United States
state: Connecticut
city: Fort Myers
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Prairie Village
country: United States
state: Kansas
city: Weymouth
country: United States
state: Massachusetts
city: Las Vegas
country: United States
state: Nevada
city: Brooklyn
country: United States
state: New York
city: Jamaica
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Portland
country: United States
state: Oregon
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
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.