Efficacy and Safety Study of Seroquel SR in the Treatment of Major Depressive Disorder

Phase 3

Completed

• Conditions: Major Depressive Disorder

• Registration Number: NCT00388973
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-10-16
• Study First Submitted QC: 2006-10-16
• Study First Posted: 2006-10-17
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Results First Submitted: 2008-12-29
• Status Verified: 2010-03
• Results First Submitted QC: 2010-03-22
• Last Update Submitted: 2010-03-22
• Results First Posted: 2010-04-01
• Last Update Posted: 2010-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 338

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Week 9.	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 Outcome Measures

Name	Time	Method
Change From Baseline for Satisfaction With Medication From Quality of Life, Enjoyment, Satisfaction Questionaire (Q-LES-Q)	Baseline to Week 9	Item 15 the Quality of Life, Enjoyment Satisfaction Questionnaire (score 1 least -5 best) on Q-LES-Q, calculated as Week 9 value - baseline value
Change From Baseline in Health-related Quality of Life, Enjoyment and Satisfaction (Q-LES-Q)	Baseline to Week 9	Q-LES-Q as percent of maximum (0 to 100%) calculated as Week 9 - baseline, where higher values indicate better quality of life.
Change From Baseline in Anxiety Symptoms Measured by Hamilton Anxiety 14 Item Scale (HAM-A)	Baseline to Week 9	Change in HAM-A total score (total score 0-56), calculated as Week 9 value - baseline value, where lower scores indicate less anxiety.
Change From Baseline in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index	Baseline to Week 9	The Pittsburgh Sleep Quality Index is an eighteen questionnaire scored with 7 sleep component scores each on a 0 to 3 scale, total score range from 0 to 21, worst value 21, best value 0
Change From Baseline in Suicidal Thoughts as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Item 10	Baseline to Week 9	The suicide item is a single item of the Montgomery-Asberg Depression Rating Scale with a range of values from 0 to 6, worst value 6, best value 0
Change From Baseline in Somatic Symptoms Cluster From the Hamilton Anxiety Scale (HAM-A)	Baseline to Week 9	The Somatic symptom Cluster of the Hamilton Anxiety Scale is a 7 item cluster associated with somatic symptoms \*somatic muscular, somatic sensory, cardiovascular system, respiratory system, gastrointestinal system, genitourinary system, autonomic system) with a range of values from 0 to 28, worst value 28, best value 0
Tolerability as Measured by Adverse Event Withdrawals During Treatment	Baseline to Week 9

Trial Locations

Locations (1)

Research Site; 🇺🇦 Vinnitsa, Ukraine