Evaluation of the Safety of Adjunct Brexpiprazole in Elderly Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Treatment
- Conditions
- Major Depressive DisorderMedDRA version: 17.1Level: LLTClassification code 10025463Term: Major depressive disorder, single episodeSystem Organ Class: 100000004873MedDRA version: 17.1Level: LLTClassification code 10025454Term: Major depressive disorder, recurrent episodeSystem Organ Class: 100000004873Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2014-003547-35-FI
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 130
- The patient is a man or woman aged =65 years
- 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 130
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the long-term safety and tolerability of brexpiprazole (1 to 3 mg/day) as adjunct treatment to antidepressant treatment (ADT) in elderly patients with MDD;Secondary Objective: Not applicable;Primary end point(s): Long-term safety and tolerability - please refer to study protocol;Timepoint(s) of evaluation of this end point: At all study visits - please refer to study protocol
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable