Overview

A Study of Quetiapine Fumarate Sustained Release in Major Depression With Comorbid Fibromyalgia Syndrome

Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
0
Participant gender:
All
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 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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Dr Alexander McIntyre Inc.
Treatments:
Quetiapine Fumarate
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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)