Phase 3
Completed N=338
Efficacy and Safety Study of Seroquel SR in the Treatment of Major Depressive Disorder
Source: ClinicalTrials.gov NCT00388973 ↗Enrolled (actual)
338
Serious AEs
1.8%
Results posted
Apr 2010
Primary outcomePrimary: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Week 9. — -16; -9 units on scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Week 9. |
-16; -9 | — |
| SECONDARY Change From Baseline in Health-related Quality of Life, Enjoyment and Satisfaction (Q-LES-Q) |
17; 9 | — |
| SECONDARY Change From Baseline for Satisfaction With Medication From Quality of Life, Enjoyment, Satisfaction Questionaire (Q-LES-Q) |
0; 0 | — |
| SECONDARY Change From Baseline in Anxiety Symptoms Measured by Hamilton Anxiety 14 Item Scale (HAM-A) |
-11; -5 | — |
| SECONDARY Change From Baseline in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index |
-6; -3 | — |
| SECONDARY Change From Baseline in Suicidal Thoughts as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Item 10 |
0; 0 | — |
| SECONDARY Change From Baseline in Somatic Symptoms Cluster From the Hamilton Anxiety Scale (HAM-A) |
-4; -2 | — |
| SECONDARY Tolerability as Measured by Adverse Event Withdrawals During Treatment |
16; 7 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00388973). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.