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

March 22, 2010 updated by: AstraZeneca

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

338

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Research Site
      • Capital Federal, Argentina
        • Research Site
      • Cordoba, Argentina
        • Research Site
      • Mendoza, Argentina
        • Research Site
    • Buenos Aires
      • City Bell, Buenos Aires, Argentina
        • Research Site
      • La Plata, Buenos Aires, Argentina
        • Research Site
  • Estonia
      • Tallinn, Estonia
        • Research Site
      • Tartu, Estonia
        • Research Site
      • Viljandi, Estonia
        • Research Site
  • Finland
      • Helsinki, Finland
        • Research Site
      • Jarvenpaa, Finland
        • Research Site
      • Kuopio, Finland
        • Research Site
      • Salo, Finland
        • Research Site
      • Seinajoki, Finland
        • Research Site
      • Tampere, Finland
        • Research Site
  • Russian Federation
      • Arkhangelsk, Russian Federation
        • Research Site
      • Izhevsk, Russian Federation
        • Research Site
      • Lipetsk, Russian Federation
        • Research Site
      • Moscow, Russian Federation
        • Research Site
      • Nizhny Novgorod, Russian Federation
        • Research Site
      • Perm, Russian Federation
        • Research Site
      • St.-petersburg, Russian Federation
        • Research Site
      • Stavropol, Russian Federation
        • Research Site
  • Ukraine
      • Dnipropetrovsk, Ukraine
        • Research Site
      • Donetsk, Ukraine
        • Research Site
      • Kiev, Ukraine
        • Research Site
      • Lugansk, Ukraine
        • Research Site
      • Odessa, Ukraine
        • Research Site
      • Vinnitsa, Ukraine
        • Research Site
    • Kiev Region
      • Glevakha, Kiev Region, Ukraine
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Research Site
    • California
      • San Diego, California, United States
        • Research Site
    • Florida
      • Ft Myers, Florida, United States
        • Research Site
      • Gainsville, Florida, United States
        • Research Site
      • Sarasota, Florida, United States
        • Research Site
    • Georgia
      • Roswell, Georgia, United States
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • Research Site
    • New York
      • Brooklyn, New York, United States
        • Research Site
    • Oregon
      • Eugene, Oregon, United States
        • Research Site
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States
        • Research Site
    • Texas
      • Austin, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

66 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to Week 9

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

October 16, 2006

First Submitted That Met QC Criteria

October 16, 2006

First Posted (Estimate)

October 17, 2006

Study Record Updates

Last Update Posted (Estimate)

April 1, 2010

Last Update Submitted That Met QC Criteria

March 22, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1448C00014
  • EUDRACT No: 2006-001196-38

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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