Clinical trial NCT02400346: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depression Disorder
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2015-03-27
Enrollment: 132
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Number of Patients With Treatment-Emergent Adverse Events
timeFrame: Baseline to 30 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Arcadia
country: United States
facility: US012
state: California
city: Miami
country: United States
facility: US004
state: Florida
city: Orlando
country: United States
facility: US007
state: Florida
city: Smyrna
country: United States
facility: US006
state: Georgia
city: O'Fallon
country: United States
facility: US002
state: Missouri
city: Toms River
country: United States
facility: US010
state: New Jersey
city: New York
country: United States
facility: US005
state: New York
city: New York
country: United States
facility: US008
state: New York
city: Staten Island
country: United States
facility: US003
state: New York
city: Oklahoma City
country: United States
facility: US014
state: Oklahoma
city: Allentown
country: United States
facility: US009
state: Pennsylvania
city: Memphis
country: United States
facility: US001
state: Tennessee
city: San Antonio
country: United States
facility: US011
state: Texas
city: Tallinn
country: Estonia
facility: EE002
city: Tartu
country: Estonia
facility: EE001
city: Tartu
country: Estonia
facility: EE004
city: Voru
country: Estonia
facility: EE003
city: Helsinki
country: Finland
facility: FI001
city: Kuopio
country: Finland
facility: FI002
city: Oulu
country: Finland
facility: FI003
city: Tampere
country: Finland
facility: FI004
city: Berlin
country: Germany
facility: DE002
city: Berlin
country: Germany
facility: DE008
city: Frankfurt
country: Germany
facility: DE003
city: Hannover
country: Germany
facility: DE007
city: Mittweida
country: Germany
facility: DE006
city: Schwerin
country: Germany
facility: DE001
city: Wiesbaden
country: Germany
facility: DE005
city: Bialystok
country: Poland
facility: PL006
city: Bydgoszcz
country: Poland
facility: PL003
city: Chelmno
country: Poland
facility: PL001
city: Gdansk
country: Poland
facility: PL005
city: Lublin
country: Poland
facility: PL004
city: Pruszcz Gdanski
country: Poland
facility: PL002
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
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.