Evaluation of the Safety of Adjunct Brexpiprazole in Elderly Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Treatment
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
2 other identifiers
interventional
132
5 countries
34
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2015
Shorter than P25 for phase_3
34 active sites
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
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 17, 2015
CompletedFirst Posted
Study publicly available on registry
March 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedResults Posted
Study results publicly available
June 26, 2017
CompletedAugust 10, 2017
July 1, 2017
1.3 years
March 17, 2015
June 2, 2017
July 11, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Baseline to 30 weeks
Study Arms (1)
Adjunct brexpiprazole
EXPERIMENTALAll patients continue their current antidepressant treatment (ADT) and receive brexpiprazole in addition
Interventions
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.
Citalopram, ecitalopram, fluoxetine, sertraline, paroxetine IR, paroxetine CR, venlafaxine IR, venlafaxine XR (extended release), desvenlafaxine, duloxetine, mirtazapine, agomelatine, bupropion; dosing according to label
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
Study Sites (34)
US012
Arcadia, California, United States
US004
Miami, Florida, United States
US007
Orlando, Florida, United States
US006
Smyrna, Georgia, United States
US002
O'Fallon, Missouri, United States
US010
Toms River, New Jersey, United States
US005
New York, New York, United States
US008
New York, New York, United States
US003
Staten Island, New York, United States
US014
Oklahoma City, Oklahoma, United States
US009
Allentown, Pennsylvania, United States
US001
Memphis, Tennessee, United States
US011
San Antonio, Texas, United States
EE002
Tallinn, Estonia
EE001
Tartu, Estonia
EE004
Tartu, Estonia
EE003
Võru, Estonia
FI001
Helsinki, Finland
FI002
Kuopio, Finland
FI003
Oulu, Finland
FI004
Tampere, Finland
DE002
Berlin, Germany
DE008
Berlin, Germany
DE003
Frankfurt, Germany
DE007
Hanover, Germany
DE006
Mittweida, Germany
DE001
Schwerin, Germany
DE005
Wiesbaden, Germany
PL006
Bialystok, Poland
PL003
Bydgoszcz, Poland
PL001
Chełmno, Poland
PL005
Gdansk, Poland
PL004
Lublin, Poland
PL002
Pruszcz Gdański, Poland
Related Publications (1)
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.
PMID: 30039634DERIVED
Results Point of Contact
- Title
- Email contact via
- Organization
- H. Lundbeck A/S
Study Officials
- STUDY DIRECTOR
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@Lundbeck.com
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
March 17, 2015
First Posted
March 27, 2015
Study Start
March 1, 2015
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
August 10, 2017
Results First Posted
June 26, 2017
Record last verified: 2017-07