Status:
COMPLETED
Comparing Quetiapine XR Monotherapy and Augmentation With Lithium Augmentation in TRD Patients
Lead Sponsor:
AstraZeneca
Conditions:
Major Depressive Disorder
Treatment Resistant Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The primary objective of the study is to evaluate the efficacy of Quetiapine extended release (XR) in combination with an selective serotonin reuptake inhibitor (SSRI) or Venlafaxine versus Lithium in...
Detailed Description
The secondary objectives of the study are to compare the effects of the three different treatment regimen as assessed by the following variables and, if applicable, by their changes from randomisation...
Eligibility Criteria
Inclusion
- Documented clinical diagnosis as confirmed by the M.I.N.I. meeting criteria from the Diagnostic and Statistical Manual of Mental disorders, 4th Edition (DSM-IV) for any of the following:296.2x MDD, Single Episode296.3x MDD, Recurrent Episode
- Current episode of depression present, at least 42 days prior to enrolment but not more than 18 months
- MADRS-Score ≥ 25 at enrolment and randomisation
Exclusion
- Patients with a DSM-IV Axis I disorder other than MDD within 6 months of randomisation
- Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patient's current psychiatric status
- Patients who, in the investigator's judgment pose a current serious suicidal or homicidal risk, or have made a suicide attempt within the past 6 months
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
688 Patients enrolled
Trial Details
Trial ID
NCT00789854
Start Date
November 1 2008
End Date
August 1 2009
Last Update
May 23 2012
Active Locations (106)
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1
Research Site
Garran, Australian Capital Territory, Australia
2
Research Site
Brisbane, Queensland, Australia
3
Research Site
Everton Park, Queensland, Australia
4
Research Site
Townsville, Queensland, Australia