Efficacy of SEROQUEL in Selective Serotonin Reuptake Inhibitors (SSRI)-Resistant Major Depressive Disorder

Major Depressive Disorder Clinical Trial

— UNIQUE  

Official title:

An Open-Label, Non-Comparative, Multi-Centre, Phase II Prospective Trial to Assess the Efficacy of Quetiapine Fumarate Augmentation of Selective Serotonin Reuptake Inhibitors (SSRIs) in SSRI-Resistant Major Depressive Disorder.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00733668
• Other study ID #: D1449C00009
• Status: Completed
• Phase: Phase 2
• First received: August 12, 2008
• Last updated: March 24, 2009
• Start date: March 2006
• Est. completion date: November 2007

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

An open-label, non-comparative, multi-centre, phase II prospective trial to assess the efficacy of Quetiapine fumarate augmentation of selective serotonin reuptake inhibitors (SSRIs) in SSRI-resistant major depressive disorder.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Inform consent

• Male and female, age between 18 and 65 years.

• Naïve to any atypical antipsychotic

• A diagnosis of major depressive disorder

Exclusion Criteria:

• No use of fluvoxamine

• Patients with a history of bipolar I or II disorder

• Diagnosis of psychotic major depression disorder

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Quetiapine fumarate (Seroquel)
300 mg, PO, 100 mg morning, 200 mg evening, 4 weeks

Locations

Country	Name	City	State
Belgium	Research Site	Brugge
Belgium	Research Site	Leuven
Belgium	Research Site	Liege
Belgium	Research Site	Sint-Truiden

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Montgomery-Asberg Depression Scale (MADRS) score		Visit 1 - > 5	No
Secondary	The Brief psychiatric Rating Scale (BPRS) scoreThe Clinical Global impression (CGI) scorePatient reported outcomes (PROs)		Visit 1 - > 5 (1 week between each visit)	No
Secondary	Sheehan Disability Scale (SDS) score		Visit 1 - > 5 (1 week between each visit)	No
Secondary	The Symptom Checklist 90 Revisred (SCL-90-R) score		Visit 1 - > 5 (1 week between each visit)	No