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

Major Depressive Disorder Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00388973
• Other study ID #: D1448C00014
• Secondary ID: EUDRACT No: 2006
• Status: Completed
• Phase: Phase 3
• First received: October 16, 2006
• Last updated: March 22, 2010
• Start date: September 2006
• Est. completion date: December 2007

Study information

• Verified date: March 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaFinland: Finnish Medicines AgencyEstonia: The State Agency of MedicineLithuania: State Medicine Control Agency - Ministry of HealthRussia: Ministry of Health of the Russian FederationUkraine: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 338
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 66 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Quetiapine

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Capital Federal
Argentina	Research Site	City Bell	Buenos Aires
Argentina	Research Site	Cordoba
Argentina	Research Site	La Plata	Buenos Aires
Argentina	Research Site	Mendoza
Estonia	Research Site	Tallinn
Estonia	Research Site	Tartu
Estonia	Research Site	Viljandi
Finland	Research Site	Helsinki
Finland	Research Site	Jarvenpaa
Finland	Research Site	Kuopio
Finland	Research Site	Salo
Finland	Research Site	Seinajoki
Finland	Research Site	Tampere
Russian Federation	Research Site	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
Ukraine	Research Site	Dnipropetrovsk
Ukraine	Research Site	Donetsk
Ukraine	Research Site	Glevakha	Kiev Region
Ukraine	Research Site	Kiev
Ukraine	Research Site	Lugansk
Ukraine	Research Site	Odessa
Ukraine	Research Site	Vinnitsa
United States	Research Site	Austin	Texas
United States	Research Site	Birmingham	Alabama
United States	Research Site	Boston	Massachusetts
United States	Research Site	Brooklyn	New York
United States	Research Site	Eugene	Oregon
United States	Research Site	Ft Myers	Florida
United States	Research Site	Gainsville	Florida
United States	Research Site	Jenkintown	Pennsylvania
United States	Research Site	Memphis	Tennessee
United States	Research Site	Roswell	Georgia
United States	Research Site	San Antonio	Texas
United States	Research Site	San Diego	California
United States	Research Site	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Argentina,  Estonia,  Finland,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score 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	No
Secondary	Change From Baseline in Health-related Quality of Life, Enjoyment and Satisfaction (Q-LES-Q)	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	No
Secondary	Change From Baseline for Satisfaction With Medication From Quality of Life, Enjoyment, Satisfaction Questionaire (Q-LES-Q)	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	No
Secondary	Change From Baseline in Anxiety Symptoms Measured by Hamilton Anxiety 14 Item Scale (HAM-A)	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	No
Secondary	Change From Baseline in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index	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	No
Secondary	Change From Baseline in Suicidal Thoughts as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Item 10	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	Yes
Secondary	Change From Baseline in Somatic Symptoms Cluster From the Hamilton Anxiety Scale (HAM-A)	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	No
Secondary	Tolerability as Measured by Adverse Event Withdrawals During Treatment		Baseline to Week 9	Yes

External Links

•   AstraZeneca Clinical Trial Information - Outside US