Evaluation of the Safety of Adjunct Brexpiprazole in Elderly Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Treatment

July 11, 2017 updated by: H. Lundbeck A/S

Interventional, Open-label, Flexible-dose, Long-term Study to Evaluate the Safety and Tolerability of Brexpiprazole as Adjunctive Treatment in Elderly Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment

The purpose of this study is to evaluate the safety and tolerability of brexpiprazole as adjunctive treatment in an elderly population with major depressive disorder and an inadequate response to antidepressant treatment

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Estonia
      • Tallinn, Estonia
        • EE002
      • Tartu, Estonia
        • EE001
      • Tartu, Estonia
        • EE004
      • Voru, Estonia
        • EE003
  • Finland
      • Helsinki, Finland
        • FI001
      • Kuopio, Finland
        • FI002
      • Oulu, Finland
        • FI003
      • Tampere, Finland
        • FI004
  • Germany
      • Berlin, Germany
        • DE002
      • Berlin, Germany
        • DE008
      • Frankfurt, Germany
        • DE003
      • Hannover, Germany
        • DE007
      • Mittweida, Germany
        • DE006
      • Schwerin, Germany
        • DE001
      • Wiesbaden, Germany
        • DE005
  • Poland
      • Bialystok, Poland
        • PL006
      • Bydgoszcz, Poland
        • PL003
      • Chelmno, Poland
        • PL001
      • Gdansk, Poland
        • PL005
      • Lublin, Poland
        • PL004
      • Pruszcz Gdanski, Poland
        • PL002
  • United States
    • California
      • Arcadia, California, United States
        • US012
    • Florida
      • Miami, Florida, United States
        • US004
      • Orlando, Florida, United States
        • US007
    • Georgia
      • Smyrna, Georgia, United States
        • US006
    • Missouri
      • O'Fallon, Missouri, United States
        • US002
    • New Jersey
      • Toms River, New Jersey, United States
        • US010
    • New York
      • New York, New York, United States
        • US005
      • New York, New York, United States
        • US008
      • Staten Island, New York, United States
        • US003
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • US014
    • Pennsylvania
      • Allentown, Pennsylvania, United States
        • US009
    • Tennessee
      • Memphis, Tennessee, United States
        • US001
    • Texas
      • San Antonio, Texas, United States
        • US011

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Main Inclusion Criteria:

  • • The patient is a man or woman aged ≥65 yrs

    • The patient has Major Depressive Disorder according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR™).
    • The patient has an inadequate response to at least one adequate antidepressant treatment in the current Major Depressive Episode (MDE).
    • The patient has had the current MDE for ≥8 weeks
    • The patient is currently treated with a protocol specified ADT for at least 6 weeks
    • The patient is judged to benefit from adjunctive treatment with brexpiprazole according to the clinical opinion of the investigator.
    • Montgomery and Åsberg Depression Rating Scale (MADRS) total score > 18 at screening and baseline
    • Clinical Global Impression - Severity (CGI-S) total score ≥3 at screening and baseline

Main Exclusion Criteria:

  • • The patient has a clinically significant unstable illness

    • The patient has newly diagnosed or unstable diabetes
    • The patient has a Mini Mental State Exam (MMSE) score <24
    • The patient has received Transcranial Magnetic Stimulation (TMS) and/or electroconvulsive therapy (ECT) less than 6 months prior to the Screening.
    • The patient, in the opinion of the investigator or based on Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation and behaviour rating, is at significant risk of suicide

Other protocol defined inclusion and exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adjunct brexpiprazole
All patients continue their current antidepressant treatment (ADT) and receive brexpiprazole in addition
Drug: Adjunct brexpiprazole

Weeks 1-4 titration from 0.5 up to 2 mg once daily, in weekly steps. For the rest of the 26 treatment weeks, maintenance with 1-3 mg once daily.

Tablets for oral use once daily during 26 weeks. Tablet strengths: 0.5 mg, 1 mg, 2 mg and 3 mg.

Drug: ADT
Citalopram, ecitalopram, fluoxetine, sertraline, paroxetine IR, paroxetine CR, venlafaxine IR, venlafaxine XR (extended release), desvenlafaxine, duloxetine, mirtazapine, agomelatine, bupropion; dosing according to label

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With Treatment-Emergent Adverse Events
Time Frame: Baseline to 30 weeks
Treatment-emergent adverse event is an adverse event that started or increased in intensity at or after baseline visit
Baseline to 30 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lundbeck A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

March 17, 2015

First Submitted That Met QC Criteria

March 23, 2015

First Posted (Estimate)

March 27, 2015

Study Record Updates

Last Update Posted (Actual)

August 10, 2017

Last Update Submitted That Met QC Criteria

July 11, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16160A
  • 2014-003547-35 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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