Status:
COMPLETED
Identifying Very Early Response to Seroquel Extended Release (XR) Augmentation for Major Depressive Disorder
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
AstraZeneca
Conditions:
Depressive Disorder, Major
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The proposed study is for a 6 week open-label clinical trial in which Seroquel XR is added to a selective serotonin reuptake inhibitor (SSRI) medication for the treatment of depressive and/or anxiety ...
Detailed Description
This study is a 6-week open-label clinical trial in which Seroquel XR is added to an antidepressant medication for the treatment of MDD with or without comorbid generalized anxiety disorder. Patients ...
Eligibility Criteria
Inclusion
- Diagnosis of major depressive disorder, currently depressed with or without a comorbid generalized anxiety disorder as determined by DSM-IV diagnostic criteria (confirmed using the MINI)
- Outpatient status
- 17-item Hamilton Depression Rating Scale (HAM-D) score of ≥ 18
- Treatment with any of the following antidepressant medications for the past 4 weeks at a minimum therapeutic dose
Exclusion
- Diagnosis of a past or current bipolar disorder
- Current psychotic symptoms
- Substance-induced mood disorder
- Substance or alcohol dependence
- Prominent current suicidal ideation as defined by a HAM-D item 3 (suicide item) score of ≥ 3
- Current treatment with more than one antidepressant medication
- Current treatment with an tricyclic (TCA) antidepressant or monoamine oxidase inhibitor (MAOI)
- A patient with Diabetes Mellitus (DM)
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00892463
Start Date
May 1 2009
End Date
December 1 2010
Last Update
July 28 2011
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5