Brexpiprazole as Adjunctive Therapy With Major Depressive Disorder and an Inadequate Response to Previous Adjunctive Therapy

NCT02012218 | Completed Phase 3 Results

• 1 other identifier: 331-13-001
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 24

Brief Summary

The objectives of this exploratory trial are to evaluate the efficacy, safety, and subjects' subjective satisfaction when switching to adjunctive brexpiprazole in subjects with MDD who have responded inadequately to preceding adjunctive drug therapy.

Conditions

Major Depressive Disorder (MDD)

Keywords

Major Depressive Disorder, Depression

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

  The MADRS was used as the primary efficacy assessment of level of depression. The MADRS was administered using the Structured Interview Guide for the MADRS. Detailed instructions were provided.The MADRS consists of 10 items each, with 7 defined grades of severity (ie, 0 to 6, 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; therefore, possible total scores range from 0 to 60. The MADRS total score least squares (LS) mean changes from baseline to Week 6 is mentioned below.

  Baseline and Week 6

Study Arms (1)

ADT and Brexpiprazole

EXPERIMENTAL

ADT and Brexpiprazole

Drug: ADT; Drug: Brexpiprazole

Interventions

ADT DRUG

ADT and Brexpiprazole

Brexpiprazole DRUG

ADT and Brexpiprazole

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of MDD
• In current major depressive episode of ≥ 8 weeks in duration and includes an inadequate response to at least 1 adjunctive treatment.
• Positive history of at least 1 additional failure to an adequate monotherapy antidepressant treatment.
• HAM-D17 total score≥ 18
• Currently receiving SSRI of SNRI with adjunctive treatment for at least 6 weeks before screening.
• Willing to discontinue use of all prohibited psychotropic medications
• Historical positive serological results for HIV, hepatitis B/C
• Able to provide written informed consent prior to the initiation of any protocol-required procedures
• Subjects who could potentially benefit from adjunctive treatment with Brexpiprazole

You may not qualify if:

• Sexually active women of childbearing potential
• Male subjects not practicing 2 different methods of birth control
• Females who are breastfeeding and/or who have a positive pregnancy test result
• Subjects who have received ECT for the current major depressive episode.
• Subjects who have had an inadequate response to ECT
• Current need for involuntary commitment or who have been hospitalized within 4 weeks of screening
• Current Axis I (DSM-IV-TR)
• Current Axis II (DSM-IV-TR)
• Subjects experiencing hallucinations, delusions, or any psychotic symptomatology in the current major depressive episode.
• Subjects receiving new onset psychotherapy.
• Subjects who answer "Yes" on the C-SSRS Suicidal Ideation Item 4, Item 5, or on any of the 5 C-SSRS Suicidal Behavior Items
• Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days
• Hypothyroidism or hyperthyroidism
• Clinically significant neurological, hepatic, renal, metabolic, haematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders
• Currently treated with insulin for diabetes

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead
• Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (24)

Collaborative NeuroScience Network, Inc.

Garden Grove, California, 92845, United States

Location

Viking Clinical Research, Ltd.

Temecula, California, 92591, United States

Location

Clinical Neuroscience Solutions Pharmacology

Orlando, Florida, 32806, United States

Location

Carman Research

Smyrna, Georgia, 30080, United States

Location

Goldpoint Clinical Research

Indianapolis, Indiana, 46260, United States

Location

Alpine Clinic

Lafayette, Indiana, 47905, United States

Location

Pharmasite Research

Baltimore, Maryland, 21208, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

Coastal Research Associates, Inc.

Weymouth, Massachusetts, 02190, United States

Location

Rochester Center for Behavioral Medicine

Rochester Hills, Michigan, 48307, United States

Location

St. Louis Clinical Trials

St Louis, Missouri, 63118, United States

Location

Center for Emotional Fitness

Cherry Hill, New Jersey, 08002, United States

Location

Behavioral Medical Research of Staten Island

Staten Island, New York, 10305, United States

Location

Richard H. Weisler, MD, PA

Raleigh, North Carolina, 27609, United States

Location

Midwest Clinical Research Center MCRC

Dayton, Ohio, 45417-3445, United States

Location

Cutting Edge Research Group

Oklahoma City, Oklahoma, 73116, United States

Location

Oregon Center for Clinical Investigations, Inc.

Portland, Oregon, 97210, United States

Location

Oregon Center for Clinical Investigations, Inc.

Salem, Oregon, 97301, United States

Location

Lehigh Center for Clinical Research

Allentown, Pennsylvania, 18104, United States

Location

Lincoln Research, LLC

Lincoln, Rhode Island, 02865, United States

Location

Research Strategies of Memphis, LLC

Memphis, Tennessee, 38119, United States

Location

Future Search Trials of Dallas, LP

Dallas, Texas, 75231, United States

Location

NeuropsychiatricAssociates

Woodstock, Vermont, 05091, United States

Location

Frontier Institute

Spokane, Washington, 99204, 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: 34894307 DERIVED

• Fava M, Okame T, Matsushima Y, Perry P, Weiller E, Baker RA. Switching from Inadequate Adjunctive or Combination Treatment Options to Brexpiprazole Adjunctive to Antidepressant: An Open-Label Study on the Effects on Depressive Symptoms and Cognitive and Physical Functioning. Int J Neuropsychopharmacol. 2017 Jan 1;20(1):22-30. doi: 10.1093/ijnp/pyw087.

  PMID: 27784751 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

brexpiprazole

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

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 4, 2013
• First Posted: December 16, 2013
• Study Start: November 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: December 29, 2015
• Results First Posted: October 8, 2015

Record last verified: 2015-11

Locations

US (24)