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

Primary Purpose

Major Depression

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Quetiapine Fumarate Sustained Release

Placebo

About this trial

This is an interventional treatment trial for Major Depression focused on measuring major depression with comorbid fibromyalgia.

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Dr. A McIntyre Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

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.

Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00675896

First Posted

May 8, 2008

Last Updated

July 3, 2011

Sponsor

Dr Alexander McIntyre Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00675896

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Completed

Study Start Date

April 2007 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Dr Alexander McIntyre Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depression

Keywords

major depression with comorbid fibromyalgia.

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Quetiapine Fumarate Sustained Release

Other Intervention Name(s)

Seroquel XR

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

1 tablet at HS for 2 days then 3 tablets at HS for 2 weeks

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexander W McIntyre, FRCPC

Organizational Affiliation

Dr. A McIntyre Inc; Penticton Regional Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dr. A McIntyre Inc

City

Penticton

State/Province

British Columbia

ZIP/Postal Code

V2A 4M4

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

24504819

Citation

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.

Results Reference

derived

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

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