Clinical trial NCT01837797: Efficacy and Safety of Brexpiprazole as Adjunctive Treatment in Elderly Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
Official title: Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study to Evaluate the Efficacy and Safety of Brexpiprazole (1 and 3 mg/Day) as Adjunctive Treatment in Elderly Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2013-04-23
Enrollment: 129
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of brexpiprazole as adjunctive treatment in elderly patients with Major Depressive Disorder (MDD)


Eligibility criteria: Inclusion Criteria:

* The patient is an outpatient consulting a psychiatrist.
* The patient has a recurrent Major Depressive Disorder diagnosed according to DSM-IV-TR™. The current Major Depressive Episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI).
* The patient had at least one previous MDE before the age of 60 years.
* The patient has a moderate to severe depression and an insufficient response to at least one and no more than three adequate antidepressants treatments.
* The patient, if a woman, must have had her last natural menstruation ≥24 months prior to the Screening Visit.
* The patient, if a man, agrees to protocol-defined use of effective contraception if his female partner is of childbearing potential.

Exclusion Criteria:

* The patient has any current psychiatric disorder or Axis I disorder (DSM-IV-TR™ criteria), established as the primary diagnosis, other than MDD.
* The patient has a current Axis II (DSM-IV-TR™) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypical or histrionic personality disorder.
* The patient has experienced/experiences hallucinations, delusions or any psychotic symptomatology in the current MDE.
* The patient suffers from mental retardation, organic mental disorders, or mental disorders due to a general medical condition (DSM-IV-TR™ criteria).
* The patient, in the opinion of the investigator, or according to Columbia Suicide Severity Rating Scale (C-SSRS), is at significant risk of suicide.
* The patient has had neuroleptic malignant syndrome.
* The patient has any relevant medical history or current presence of systemic disease.
* The patient has a neurodegenerative disorder.
* The patient has, at the Screening Visit an abnormal ECG that is, in the investigator's opinion, clinically significant.
* The patient has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin, that has not been in remission for \>5 years prior to the first dose of IMP.
* The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.

Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Change From Randomisation in Depressive Symptoms During the Randomised Treatment
timeFrame: From randomisation to end of treatment (week 20)
Secondary outcomes:
measure: Number of Adverse Events
timeFrame: From randomisation to follow-up (week 24)
measure: Change From Randomisation in Clinical Global Impression During the Randomised Treatment
timeFrame: From randomisation to end of treatment (week 20)
measure: Change From Randomisation in Functionality Assessed by SDS During the Randomised Treatment
timeFrame: From randomisation to end of treatment (week 20)
measure: Change From Randomisation in Social Adaptation During the Randomised Treatment
timeFrame: From randomisation to end of treatment (week 20)
measure: Response During the Randomised Treatment
timeFrame: From randomisation to end of treatment (week 20)
measure: Sustained Response During the Randomised Treatment
timeFrame: From randomisation to end of treatment (week 20)
measure: Remission During the Randomised Treatment
timeFrame: From randomisation to end of treatment (week 20)
measure: Sustained Remission During the Randomised Treatment
timeFrame: From randomisation to end of treatment (week 20)
measure: Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)
timeFrame: From randomisation to end of treatment (week 20)
Other outcomes:
Locations:
city: National City
country: United States
facility: US001
state: California
city: Orlando
country: United States
facility: US008
state: Florida
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: