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Clinical Trials/NCT00388973
NCT00388973CompletedPhase 3

A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SR) in the Treatment of Elderly Patients With Major Depressive Disorder

AstraZeneca43 sites in 6 countries338 target enrollmentStarted: September 1, 2006Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
338
Locations
43
Primary Endpoint
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Week 9.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
66 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Week 9.

Time Frame: Baseline to Week 9

MADRS total score (0-60 units), where lower scores indicate less depressive symptoms, calculated as Week 9 value - baseline value.

Secondary Outcomes

  • Change From Baseline in Health-related Quality of Life, Enjoyment and Satisfaction (Q-LES-Q)(Baseline to Week 9)
  • Change From Baseline for Satisfaction With Medication From Quality of Life, Enjoyment, Satisfaction Questionaire (Q-LES-Q)(Baseline to Week 9)
  • Change From Baseline in Anxiety Symptoms Measured by Hamilton Anxiety 14 Item Scale (HAM-A)(Baseline to Week 9)
  • Change From Baseline in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index(Baseline to Week 9)
  • Change From Baseline in Suicidal Thoughts as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Item 10(Baseline to Week 9)
  • Change From Baseline in Somatic Symptoms Cluster From the Hamilton Anxiety Scale (HAM-A)(Baseline to Week 9)
  • Tolerability as Measured by Adverse Event Withdrawals During Treatment(Baseline to Week 9)

Investigators

Sponsor Class
Industry

Study Sites (43)

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