Seroquel in Bipolar Depression Versus SSRI

Phase 3

Completed

• Conditions: Bipolar Disorder; Bipolar Depression; Depression

• Registration Number: NCT00119652
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to determine whether quetiapine is effective and safe in the acute treatment of bipolar depression and whether the effect is maintained when treatment is continued.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-07-06
• Study First Submitted QC: 2005-07-13
• Study First Posted: 2005-07-14
• Study Completion: 2007-05
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-03
• Last Update Posted: 2013-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 676

Inclusion Criteria

• Male and female out-patients aged 18 to 65 years inclusive
• Diagnosis of Bipolar Disorder (Bipolar I or Bipolar II), most recent episode depressed

Exclusion Criteria

• Current period of depression lasting less than 4 weeks or more than 12 months
• Use of prohibited medication
• Substance or alcohol dependence or abuse
• Current suicide risk or suicide attempt within 6 months
• Breast feeding or pregnancy
• Clinically relevant disease or clinical finding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline to Week 8 assessment in the total score on the Montgomery-Asberg Depression Rating Scale (MADRS)

Secondary Outcome Measures

Name	Time	Method
Secondary variables supportive to the primary objective:
MADRS total score response
MADRS total score remission

Trial Locations

Locations (1)

Research Site; 🇹🇷 Manisa, Turkey