A Phase 3b Multicenter Study of Pregabalin in Fibromyalgia Subjects Who Have Comorbid Depression



Status:Completed
Conditions:Depression, Fibromyalgia, Pain
Therapuetic Areas:Musculoskeletal, Psychiatry / Psychology, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:11/30/-0001
Start Date:October 2011
End Date:July 2013
Contact:Pfizer CT.gov Call Center
Phone:1-800-718-1021

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A Phase 3b Multicenter, Double-Blind, Randomized, Placebo-Controlled, 2-Way Crossover Study of Pregabalin in the Treatment of Fibromyalgia With Concurrent Antidepressant Therapy for Comorbid Depression


The intent of this study is to identify and treat fibromyalgia subjects with comorbid
depression who are receiving an SSRI (selective serotonin reuptake inhibitor) or SNRI
(selective norepinephrine reuptake inhibitor) primarily for their depression and to
determine whether pregabalin demonstrates improvement relative to placebo in improving pain
associated with fibromyalgia.


Inclusion Criteria:

- Men or women of any race or ethnicity who are at least 18 years of age.

- Adult women and men with a diagnosis of fibromyalgia and stable depression (major
depressive disorder, depression not otherwise specified (NOS), or dysthymia) who have
been taking an antidepressant (SSRI or SNRI) primarily for their depression for at
least 3 months.

Exclusion Criteria:

- Have failed pregabalin treatment due to lack of improvement of symptoms at doses of
greater than or equal to 300 mg daily, cannot tolerate pregabalin or any pregabalin
ingredient, or participated in a pregabalin clinical trial. If the subject has taken
pregabalin and discontinued for reason other than lack of improvement or intolerance,
then they will be eligible. Pregabalin use within the last 30 days (prior to V1) is
not permitted.

- Patients with severe or unstable depression are not eligible.

- Patients with other types of pain or conditions that may make it difficult to
evaluate fibromyalgia symptoms are not eligible

- Any subject considered at risk of suicide or self harm based on investigator judgment
and/or the details of a risk assessment
We found this trial at
27
sites
1156 Bowman Road
Mt Pleasant, South Carolina 29464
843-856-3784
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325 Winding River Lane
, Virginia 22911
434-817-2442
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, VA
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1904 East Barnett Road
Medford, Oregon 97504
541-973-2080
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Medford, OR
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4751 66th St N
St Petersburg, Florida 33709
727-347-8839
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St Petersburg, FL
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6261 N. La Cholla Blvd
Tucson, Arizona 85741
520-219-6394
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Tucson, AZ
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400 Bald Hill Road
Warwick, Rhode Island 02886
401-739-9350
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Warwick, RI
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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Akron, Ohio 44311
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Akron, OH
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Ann Arbor, MI
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Austin, Texas 78703
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Beverly Hills, California 90211
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Boston, Massachusetts 02135
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Boston, MA
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Brooklyn, New York 11235
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Brooklyn, NY
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Clearwater, Florida 33756
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Columbus, GA
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Coral Gables, Florida 33134
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Dayton, OH
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East Greenwich, Rhode Island 02818
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Lexington, Kentucky 40509
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Lexington, KY
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10040 Regency Cir
Omaha, Nebraska 68114
(402) 934-0044
Quality Clinical Research, Inc. Welcome to Quality Clinical Research. We originated here in Omaha, NE...
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Orange, California 92868
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Salt Lake City, Utah 84102
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Salt Lake City, Utah 84106
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Santa Ana, California 92705
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Wyomissing, Pennsylvania 19610
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Wyomissing, Pennsylvania 19610
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