Evaluation of the Safety of Adjunct Brexpiprazole in Elderly Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Treatment
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
H. Lundbeck A/S
Age
65–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | Evaluation of the Safety of Adjunct Brexpiprazole in Elderly Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Treatment
