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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
Sponsor:
Information provided by:
Dr Alexander McIntyre Inc.

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 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

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 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: 1
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
Placebo
Drug: Placebo
1 tablet at HS for 2 days then 3 tablets at HS for 2 weeks




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Locations
Canada, British Columbia
Dr. A McIntyre Inc
Penticton, British Columbia, Canada, V2A 4M4
Sponsors and Collaborators
Dr Alexander McIntyre Inc.
Investigators
Principal Investigator: Alexander W McIntyre, FRCPC Dr. A McIntyre Inc; Penticton Regional Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Alexander McIntyre ., Dr Alexander McIntyre Inc.
ClinicalTrials.gov Identifier: NCT00675896     History of Changes
Other Study ID Numbers: D1443C00007
D1443C00007
First Posted: May 12, 2008    Key Record Dates
Last Update Posted: July 6, 2011
Last Verified: July 2011

Keywords provided by Dr Alexander McIntyre Inc.:
major depression with comorbid fibromyalgia.

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Fibromyalgia
Myofascial Pain Syndromes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs