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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder

Intervention: Quetiapine fumarate (Seroquel) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Pr. Demyttenaere, Study Director, Affiliation: KUL

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.

Clinical Details

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.

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

Primary outcome: The Montgomery-Asberg Depression Scale (MADRS) score

Secondary outcome:

The Brief psychiatric Rating Scale (BPRS) scoreThe Clinical Global impression (CGI) scorePatient reported outcomes (PROs)

Sheehan Disability Scale (SDS) score

The Symptom Checklist 90 Revisred (SCL-90-R) score

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Research Site, Brugge, Belgium

Research Site, Leuven, Belgium

Research Site, Liege, Belgium

Research Site, Sint-Truiden, Belgium

Additional Information

Starting date: March 2006
Last updated: March 24, 2009

Page last updated: August 23, 2015

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