To evaluate the efficacy and safety of brexpiprazole as adjunctive treatment in elderly patients with Major Depressive Disorder (MDD)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
129
Once daily, tablets, orally
once daily dose, tablets, orally
once daily dose, tablets, orally
US001
National City, California, United States
US008
Orlando, Florida, United States
Change From Randomisation in Depressive Symptoms During the Randomised Treatment
Montgomery and Aasberg Depression Rating Scale (MADRS) total score
Time frame: From randomisation to end of treatment (week 20)
Number of Adverse Events
15 patients were enrolled to Period 2; only 3 patients completed due to study termination
Time frame: From randomisation to follow-up (week 24)
Change From Randomisation in Clinical Global Impression During the Randomised Treatment
Clinical Global Impression - Severity of illness (CGI-S) score
Time frame: From randomisation to end of treatment (week 20)
Change From Randomisation in Functionality Assessed by SDS During the Randomised Treatment
Sheehan Disability Scale (SDS) total score
Time frame: From randomisation to end of treatment (week 20)
Change From Randomisation in Social Adaptation During the Randomised Treatment
Social Adaptation Self-evaluation Scale (SASS) total score
Time frame: From randomisation to end of treatment (week 20)
Response During the Randomised Treatment
Based on a pre-specified decrease in MADRS total score
Time frame: From randomisation to end of treatment (week 20)
Sustained Response During the Randomised Treatment
Based on a pre-specified decrease in MADRS total score
Time frame: From randomisation to end of treatment (week 20)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Remission During the Randomised Treatment
Based on a pre-specified MADRS total score
Time frame: From randomisation to end of treatment (week 20)
Sustained Remission During the Randomised Treatment
Based on a pre-specified MADRS total score
Time frame: From randomisation to end of treatment (week 20)
Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)
The Columbia Suicide Severity Rating Scale (eC-SSRS) is a semi-structured interview developed to systematically assess suicidal ideation and behaviour of patients participating in a clinical study. The C-SSRS has 5 questions addressing suicidal ideation, 5 sub-questions assessing the intensity of ideation, and 4 questions addressing suicidal behaviour.
Time frame: From randomisation to end of treatment (week 20)