Quetiapine XR versus Sertraline in acute bipolar depression as add-on therapy

Study identifier:D1443L00058

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Effectiveness of Quetiapine XR versus Sertraline in acute depression as add-on therapy to previous mood stabilizer treatment: a pilot study

Medical condition

Bipolar Disorder

Phase

Phase 3

Healthy volunteers

No

Study drug

Extended release quetiapine (quetiapine XR), Sertraline, adequate mood stabilizer

Sex

All

Actual Enrollment

27

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 01 May 2009
Primary Completion Date: 01 Feb 2011
Study Completion Date: 01 Feb 2011

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2012 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria