Status:
COMPLETED
A Study of Quetiapine Fumarate Sustained Release in Major Depression With Comorbid Fibromyalgia Syndrome
Lead Sponsor:
Dr Alexander McIntyre Inc.
Conditions:
Major Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
To compare the efficacy of Quetiapine SR versus placebo over 8 weeks in unipolar non-psychotic adult outpatients depression and comorbid fibromyalgia. This will be measured by the last observation car...
Detailed Description
Secondary Endpoints include * Change from baseline to week 8 in Brief Pain Inventory (short form) total score. * Changes from baseline to week 8 in HAM-A total scores Changes from baseline to week 8 ...
Eligibility Criteria
Inclusion
- Patients with a DSM IV diagnosis of major depression and fibromyalgia confirmed by using the American College of Rheumatology criteria. Male or female between the ages of 18 and 65.
- Patients who score at least 22 on the 17-item HAM-D scale and at least 4 (i.e., moderately ill) on the Clinical Global Impression (CGI) severity scale. Both criteria have to be met at screening and baseline (Study Day 0).
Exclusion
- Patients with DSM-IV Axis 1 disorder other than MDD and Chronic Pain Disorder within 6 months of enrolment.
- History of inadequate response to adequate treatment (6 weeks) with 2 or more classes of antidepressants during current depressive episode.
- Patients who, in the investigator's opinion, pose a risk for suicide.
- History of suicide attempt within 3 years of entering study.
- Current depressive episode secondary to general medical condition excluding Fibromyalgia.
- History or presence of bipolar disorder or psychosis.
- Post traumatic stress disorder, anorexia nervosa or bulimia nervosa.
- Patients with diagnosis of DSM-IV Axis II disorder which has a major impact on the patient's current psychiatric status.
- Present DSM IV diagnosis of substance abuse or dependence within 6 months prior of the screening visit (except dependence in full remission, and except caffeine, nicotine or opiate dependence)
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2011
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00675896
Start Date
April 1 2007
End Date
July 1 2011
Last Update
July 6 2011
Active Locations (1)
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1
Dr. A McIntyre Inc
Penticton, British Columbia, Canada, V2A 4M4