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

Primary Purpose

Major Depression Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Adjunct brexpiprazole
ADT
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression Disorder

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • US012
  • US004
  • US007
  • US006
  • US002
  • US010
  • US005
  • US008
  • US003
  • US014
  • US009
  • US001
  • US011
  • EE002
  • EE001
  • EE004
  • EE003
  • FI001
  • FI002
  • FI003
  • FI004
  • DE002
  • DE008
  • DE003
  • DE007
  • DE006
  • DE001
  • DE005
  • PL006
  • PL003
  • PL001
  • PL005
  • PL004
  • PL002

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adjunct brexpiprazole

Arm Description

All patients continue their current antidepressant treatment (ADT) and receive brexpiprazole in addition

Outcomes

Primary Outcome Measures

Number of Patients With Treatment-Emergent Adverse Events
Treatment-emergent adverse event is an adverse event that started or increased in intensity at or after baseline visit

Secondary Outcome Measures

Full Information

First Posted
March 17, 2015
Last Updated
July 11, 2017
Sponsor
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT02400346
Brief Title
Evaluation of the Safety of Adjunct Brexpiprazole in Elderly Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Treatment
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S

4. Oversight

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adjunct brexpiprazole
Arm Type
Experimental
Arm Description
All patients continue their current antidepressant treatment (ADT) and receive brexpiprazole in addition
Intervention Type
Drug
Intervention Name(s)
Adjunct brexpiprazole
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
ADT
Intervention Description
Citalopram, ecitalopram, fluoxetine, sertraline, paroxetine IR, paroxetine CR, venlafaxine IR, venlafaxine XR (extended release), desvenlafaxine, duloxetine, mirtazapine, agomelatine, bupropion; dosing according to label
Primary Outcome Measure Information:
Title
Number of Patients With Treatment-Emergent Adverse Events
Description
Treatment-emergent adverse event is an adverse event that started or increased in intensity at or after baseline visit
Time Frame
Baseline to 30 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@Lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
US012
City
Arcadia
State/Province
California
Country
United States
Facility Name
US004
City
Miami
State/Province
Florida
Country
United States
Facility Name
US007
City
Orlando
State/Province
Florida
Country
United States
Facility Name
US006
City
Smyrna
State/Province
Georgia
Country
United States
Facility Name
US002
City
O'Fallon
State/Province
Missouri
Country
United States
Facility Name
US010
City
Toms River
State/Province
New Jersey
Country
United States
Facility Name
US005
City
New York
State/Province
New York
Country
United States
Facility Name
US008
City
New York
State/Province
New York
Country
United States
Facility Name
US003
City
Staten Island
State/Province
New York
Country
United States
Facility Name
US014
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
US009
City
Allentown
State/Province
Pennsylvania
Country
United States
Facility Name
US001
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
US011
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
EE002
City
Tallinn
Country
Estonia
Facility Name
EE001
City
Tartu
Country
Estonia
Facility Name
EE004
City
Tartu
Country
Estonia
Facility Name
EE003
City
Voru
Country
Estonia
Facility Name
FI001
City
Helsinki
Country
Finland
Facility Name
FI002
City
Kuopio
Country
Finland
Facility Name
FI003
City
Oulu
Country
Finland
Facility Name
FI004
City
Tampere
Country
Finland
Facility Name
DE002
City
Berlin
Country
Germany
Facility Name
DE008
City
Berlin
Country
Germany
Facility Name
DE003
City
Frankfurt
Country
Germany
Facility Name
DE007
City
Hannover
Country
Germany
Facility Name
DE006
City
Mittweida
Country
Germany
Facility Name
DE001
City
Schwerin
Country
Germany
Facility Name
DE005
City
Wiesbaden
Country
Germany
Facility Name
PL006
City
Bialystok
Country
Poland
Facility Name
PL003
City
Bydgoszcz
Country
Poland
Facility Name
PL001
City
Chelmno
Country
Poland
Facility Name
PL005
City
Gdansk
Country
Poland
Facility Name
PL004
City
Lublin
Country
Poland
Facility Name
PL002
City
Pruszcz Gdanski
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
30039634
Citation
Lepola U, Hefting N, Zhang D, Hobart M. Adjunctive brexpiprazole for elderly patients with major depressive disorder: An open-label, long-term safety and tolerability study. Int J Geriatr Psychiatry. 2018 Oct;33(10):1403-1410. doi: 10.1002/gps.4952. Epub 2018 Jul 23.
Results Reference
derived

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

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