Efficacy and Safety Study of Seroquel SR in the Treatment of Major Depressive Disorder
Status and phase
Completed
Phase 3
Conditions
Major Depressive Disorder
Treatments
Drug: Quetiapine
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
The primary purpose of this study is to evaluate whether treatment with (SEROQUEL SR) quetiapine fumarate sustained release (SR) for 9 weeks compared to placebo will improve depressive symptoms in elderly patients with major depressive disorder.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Enrollment
338 patients
Sex
All
Ages
66+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Male or female patients, 66 years or older, with a documented clinical diagnosis of MDD.
Exclusion criteria
- The presence of dementia or mental disorder other than MDD within 6 months of enrolment,
- Uncontrolled hypertension, substance or alcohol abuse
- A current diagnosis of cancer or a current or past diagnosis of stroke
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
Trial contacts and locations
43
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Data sourced from clinicaltrials.gov
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