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

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.

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.

Study Overview

• Status: Completed
• Conditions: Major Depression
• Intervention / Treatment: Drug: Quetiapine Fumarate Sustained Release; Drug: Placebo

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
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Penticton, British Columbia, Canada, V2A 4M4
      • Dr. A McIntyre Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Placebo	Drug: Placebo; 1 tablet at HS for 2 days then 3 tablets at HS for 2 weeks
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 Names: Seroquel XR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
last observation carried forward (LOCF) mean change from baseline to week 8 on the Hamilton Depression Scale (HAM-D) total score.	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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	8 weeks

Collaborators and Investigators

• Sponsor: Dr Alexander McIntyre Inc.
• Investigators: Principal Investigator: Alexander W McIntyre, FRCPC, Dr. A McIntyre Inc; Penticton Regional Hospital

Publications and helpful links

General Publications

• McIntyre A, Paisley D, Kouassi E, Gendron A. Quetiapine fumarate extended-release for the treatment of major depression with comorbid fibromyalgia syndrome: a double-blind, randomized, placebo-controlled study. Arthritis Rheumatol. 2014 Feb;66(2):451-61. doi: 10.1002/art.38228.

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: May 8, 2008
• First Submitted That Met QC Criteria: May 9, 2008
• First Posted (Estimate): May 12, 2008

Study Record Updates

• Last Update Posted (Estimate): July 6, 2011
• Last Update Submitted That Met QC Criteria: July 3, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: major depression with comorbid fibromyalgia.
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Nervous System Diseases; Mood Disorders; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Depression; Depressive Disorder; Fibromyalgia; Myofascial Pain Syndromes; Depressive Disorder, Major; Physiological Effects of Drugs; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Quetiapine Fumarate
• Other Study ID Numbers: D1443C00007