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

NCT00675896 | Completed Phase 4

• 1 other identifier: D1443C00007
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depression

Keywords

major depression with comorbid fibromyalgia.

Outcome Measures

Primary Outcomes (1)

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

  8 weeks

Secondary Outcomes (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

  8 weeks

Study Arms (2)

1

EXPERIMENTAL

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

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Quetiapine Fumarate Sustained Release DRUG

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

Also known as: Seroquel XR

1

Placebo DRUG

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

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dr Alexander McIntyre Inc.: lead

Study Sites (1)

Dr. A McIntyre Inc

Penticton, British Columbia, V2A 4M4, Canada

Location

Related Publications (1)

• 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.

  PMID: 24504819 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Alexander W McIntyre, FRCPC

  Dr. A McIntyre Inc; Penticton Regional Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 8, 2008
• First Posted: May 12, 2008
• Study Start: April 1, 2007
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 6, 2011

Record last verified: 2011-07

Locations

CA (1)