A Study of Quetiapine Fumarate Sustained Release in Major Depression With Comorbid Fibromyalgia Syndrome
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|ClinicalTrials.gov Identifier: NCT00675896|
Recruitment Status : Completed
First Posted : May 12, 2008
Last Update Posted : July 6, 2011
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 carried forward (LOCF) mean change from baseline to week 8 on the Hamilton Depression Scale (HAM-D) total score.
For the purposes of this study, response regarding improvement in depressive symptoms will be defined as a 50% decrease in HAM-D scores over 8 weeks. Furthermore, proportion of patients achieving remission is defined as an HAM-D total score of 7 at end of treatment. The anxiety comorbid symptoms often associated with major depression will be assessed with the HAM-A (14 items) scale. Proportion of patients responding and achieving remission of anxiety symptoms are defined respectively as a reduction of 50% in the HAM-A total score from baseline and a HAM-A total score of 7 at the end of treatment.
|Condition or disease||Intervention/treatment||Phase|
|Major Depression||Drug: Quetiapine Fumarate Sustained Release Drug: Placebo||Phase 4|
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 in CGI Severity of illness scores. Clinical Global Impression - Improvement (CGI-I) score from randomisation to Week 8 Change from baseline in the Fibromyalgia Impact Questionnaire (FIQ). Change from baseline in the Sleep Scale from the Medical Outcome Study (MOS). Change from baseline in the Sheehan Disability Scale (SDS). Change from baseline in the Quality of Life Enjoyment and Satisfaction Questionnaire- Short Form (Q-LES-Q-SF).
Change from baseline in the Patient Health Questionaire-15 (PHQ-15). Change from baseline in the Global Assessment Scale (GAS).
The side effects and the tolerability profiles of Quetiapine SR at the dose range used in the study will be assessed at every visit following the initial visit.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Double Blind, Randomized Placebo Controlled Study of the Efficacy, Safety and Tolerability of Quetiapine Fumarate Sustained Release(Seroquel SRTM) in the Treatment of Major Depression With Comorbid Fibromyalgia Syndrome.|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||July 2011|
Quetiapine Fumarate Sustained Release(Seroquel SR)50 mg/day for the first 2 days and then up to 150mg/day. After two weeks the dose will be doubled up to 300mg at night at the discretion of the investigator, using patient tolerance and response as guidelines over the duration of the trial.
Drug: Quetiapine Fumarate Sustained Release
50 mg/day for the first 2 days and then up to 150mg/day. After two weeks the dose will be doubled up to 300mg at night at the discretion of the investigator
Other Name: Seroquel XR
Placebo Comparator: 2
1 tablet at HS for 2 days then 3 tablets at HS for 2 weeks
- last observation carried forward (LOCF) mean change from baseline to week 8 on the Hamilton Depression Scale (HAM-D) total score. [ Time Frame: 8 weeks ]
- Change from baseline to week 8 in: Brief Pain Inventory,HAM-A,CGI-S,FIQ, Sleep Scale from the Medical Outcome Study,SDS,QLES- Short Form,PHQ-15,Global Assessment Scale,Improvement (CGI-I) score from randomisation to Week 8 [ Time Frame: 8 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00675896
|Canada, British Columbia|
|Dr. A McIntyre Inc|
|Penticton, British Columbia, Canada, V2A 4M4|
|Principal Investigator:||Alexander W McIntyre, FRCPC||Dr. A McIntyre Inc; Penticton Regional Hospital|