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Completed

NCT Number: NCT00388973

Efficacy and Safety Study of Seroquel SR in the Treatment of 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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

66 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, City Bell, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quetiapine

Drug

Primary outcomes

  1. 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

  1. 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.

  2. 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

  3. 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.

  4. 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

  5. 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

  6. 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

  7. Tolerability as Measured by Adverse Event Withdrawals During Treatment

    Time frame: Baseline to Week 9

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Oct 17, 2006
Registry last updated
Apr 1, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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