NCT02013531

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at below P25 for phase_3 major-depressive-disorder

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_3 major-depressive-disorder

Geographic Reach
1 country

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 6, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 17, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

March 29, 2016

Completed
Last Updated

March 29, 2016

Status Verified

February 1, 2016

Enrollment Period

6 months

First QC Date

December 6, 2013

Results QC Date

August 4, 2015

Last Update Submit

February 26, 2016

Conditions

Major Depressive DisorderAnxiety

Keywords

schizophreniaMajor depressive disorderAnxiety SymptomsMental DisordersPsychotic Disordersemotional withdrawalantipsychotic

Outcome Measures

Primary Outcomes (1)

  • Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

    The MADRS is utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60, with higher values indicating worse outcome.

    Baseline, Week 6

Secondary Outcomes (18)

  • Mean Change in Clinical Global Impression-Severity (CGI-S) Total Score

    Baseline, Week 6

  • Mean Clinical Global Impression-Improvement (CGI-I) Score at Week 6.

    Baseline, Week 6

  • Percentage of Participants With CGI-I Response Rate

    Week 1 to Week 6

  • Percentage of Participants With a MADRS Response

    Week 6

  • Percentage of Participants With a MADRS Remission

    Week 6

  • +13 more secondary outcomes

Study Arms (1)

Brexpiprazole

EXPERIMENTAL

Up to 3 mg/day, once daily dose, tablets, orally

Drug: Brexpiprazole

Interventions

BrexpiprazoleDRUG

Treatment (6 weeks) - Up to 3mg/day, once daily dose, tablets, orally

Brexpiprazole

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Unknown Facility

Tuscon, Arizona, 85712, United States

Location

Unknown Facility

Garden Grove, California, 92845, United States

Location

Unknown Facility

Oceanside, California, 92056, United States

Location

Unknown Facility

Temecula, California, 92591, United States

Location

Unknown Facility

Gainesville, Florida, 32607, United States

Location

Unknown Facility

Jacksonville, Florida, 32256, United States

Location

Unknown Facility

Miami, Florida, 33145, United States

Location

Unknown Facility

Atlanta, Georgia, 30308, United States

Location

Unknown Facility

Lafayette, Indiana, 47905, United States

Location

Unknown Facility

Baltimore, Maryland, 21208, United States

Location

Unknown Facility

Boston, Massachusetts, 02131, United States

Location

Unknown Facility

Haverhill, Massachusetts, 01830, United States

Location

Unknown Facility

Rochester Hills, Michigan, 48307, United States

Location

Unknown Facility

New York, New York, 10168, United States

Location

Unknown Facility

Staten Island, New York, 10305, United States

Location

Unknown Facility

Salem, Oregon, 97301, United States

Location

Unknown Facility

Allentown, Pennsylvania, 18104, United States

Location

Unknown Facility

Arlington, Texas, 76012, United States

Location

Unknown Facility

Austin, Texas, 78731, United States

Location

Unknown Facility

Woodstock, Vermont, 05091, United States

Location

Unknown Facility

Richmond, Virginia, 23230, United States

Location

Related Publications (2)

  • 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.

    PMID: 34894307DERIVED

  • 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.

    PMID: 27781135DERIVED

MeSH Terms

Conditions

Depressive Disorder, MajorAnxiety DisordersSchizophreniaMental DisordersPsychotic Disorders

Interventions

brexpiprazole

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Results Point of Contact

Title
Global Medical Affairs
Organization
Otsuka Pharmaceutical Development and Commercialization, Inc.
800 562-3974

Study Officials

  • Junichi Hashimoto, PhD

    Otsuka Pharmaceutical Co., Ltd Japan (OPCJ)

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2013

First Posted

December 17, 2013

Study Start

November 1, 2013

Primary Completion

May 1, 2014

Study Completion

June 1, 2014

Last Updated

March 29, 2016

Results First Posted

March 29, 2016

Record last verified: 2016-02

Locations

US(21)