The Safety and Efficacy of Brexpiprazole as Adjunctive Therapy in the Treatment of Major Depressive Disorder

NCT03487198 | Terminated Phase 3

• 1 other identifier: 331-403-00023
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multicenter, randomized, double-blind, placebo-controlled trial designed to assess the efficacy and safety of brexpiprazole as adjunctive therapy in the treatment of Major Depressive Disorder. A total of approximately 1100 subjects will be enrolled into the single-blind treatment for 6 weeks, and 480 incomplete responders will be randomized to brexpiprazole (2\~3 mg) or placebo in a 1:1 ratio (approximately 240 subjects in each group), for treatment of 6 weeks.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; Brexpiprazole

Outcome Measures

Primary Outcomes (1)

• Change from the end of Phase A (Week 8 visit) to the end of Phase B (Week 14 visit) in the MADRS Total Score

  The objective of the primary analysis is to compare the efficacy of brexpiprazole (2\~3 mg/day) to placebo as adjunctive therapy to an assigned open-label ADT in adult subjects with MDD who demonstrate an incomplete response after 8 weeks of treatment with the same assigned open-label antidepressant therapy (ADT). The efficacy is assessed by the change from the end of Phase A (Week 8 visit) to the end of Phase B (Week 14 visit) in the MADRS Total Score

  Week 8 and Week 14

Secondary Outcomes (10)

• Change from the end of Phase A (Week 8 visit) to the end of Phase B (Week 14 visit) in SDS Mean Score

  Week 8 and Week 14

• Change from the end of Phase A (Week 8 visit) in MADRS Total Score for every trial week visit in Phase B other than Week 14 visit

  Week 8 and Week 14

• Change from the end of Phase A (Week 8 visit) for every trial week visit in Phase B in CGI - Severity of Illness scale (CGI-S) score

  Week 8 and Week 14

• Change from the end of Phase A (Week 8 visit) to the end of Phase B (Week 14 visit) in HAM-D17 Score

  Week 8 and Week 14

• CGI - Improvement scale (CGI-I) score for every trial week visit in Phase B

  Week 8 and Week 14

Study Arms (2)

Brexpiprazole

EXPERIMENTAL

2-3 mg/day, once daily for 6 weeks, oral administration

Drug: Brexpiprazole

Placebo

PLACEBO COMPARATOR

2-3 mg/day, once daily for 6 weeks, oral administration

Drug: Placebo

Interventions

Brexpiprazole DRUG

Brexpiprazole 2-3mg/day

Brexpiprazole

Placebo DRUG

Placebo 2-3 mg/day

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject who are able to provide signed written informed consent.
• Male and female outpatients 18 to 65 years of age, inclusive, at the time of signing the informed consent.
• Subjects with both a diagnosis of MDD, and in a current Major Depressive Episode, according to the diagnostic criteria in DSM-IV-TR and confirmed by the Mini International Neuropsychiatric Interview (MINI). The current Major Depressive Episode must be ≥ 8 weeks in duration.
• Subjects must have reported a history for the current Major Depressive Episode of an inadequate response to at least one and no more than three standard antidepressant treatments (including any antidepressants being received during Screening period, if the antidepressants treatment meets criteria of standard treatment). For the most recent antidepressant treatment, the subject must not report ≥ 50% improvement.
• Standard treatment is defined as: an antidepressant treatment for at least 6 weeks in duration (at least 3 weeks if combined treatment) at a minimum effective dose (or higher) according to prescription drug labels. At least once of 1 to 3 standard treatments is monotherapy for more than 6 weeks.
• An inadequate response is defined as: \< 50% reduction in depressive symptom severity, as measured by the subject's self-report score on Visual Analogue Scale (VAS).
• Subjects with a HAM-D17 Total Score ≥ 18 at the Screening and Baseline visits.
• Phase B (Double-blind Randomization Phase)
• HAM-D17 total score ≥14 at the end of phase A.
• \< 50% reduction in HAM-D17 total score at the end of phase A (end of Week 8) relative to baseline.
• A CGI-I score ≥ 3 at Weeks 2, 4, 6, and 8.

You may not qualify if:

• Females of childbearing potential and male subjects who are not willing to or cannot practice contraceptive methods during the trial and for 30 days after the last dose.
• Females who are breast-feeding or lactating and who have a positive pregnancy test result (Urine or serum test) prior to screening or randomization (within 72 hours).
• Subjects who report treatment with adjunctive antipsychotic medication with an antidepressant during the current Major Depressive Episode.
• Subjects who report allergies or an intolerability to all protocol-specified ADTs or subjects with contraindication for protocol-specified ADTs described in their prescription drug labels.
• Subjects who have had an ECT treatment history at any time in the past or at present, or who have had a vagus nerve stimulation or deep brain stimulation device implanted for management of treatment-resistant depression.
• Subjects with a current need for hospitalization or who have been hospitalized within four weeks prior to screening for the current Major Depressive Episode.
• Subjects with a current Axis I (DSM-IV-TR) diagnosis of:
• Delirium, dementia, amnestic or other cognitive disorder
• Schizophrenia, schizoaffective disorder, or other psychotic disorder
• Bipolar I or II disorder
• Eating disorder (including anorexia nervosa or bulimia)
• Obsessive compulsive disorder
• Panic disorder
• Post-traumatic stress disorder
• Subjects with a current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.

Sponsors & Collaborators

• Otsuka Beijing Research Institute: lead

Study Sites (1)

Beijing Anding Hospital of Capital Medical University

Beijing, Beijing Municipality, 100088, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

brexpiprazole

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Patyman Juma

  Otsuka Beijing Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: April 3, 2018
• Study Start: May 30, 2018
• Primary Completion: May 30, 2019
• Study Completion: May 30, 2019
• Last Updated: December 29, 2020

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)