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

Completed · Phase 3 · Has a placebo group

Conditions studied: Fibromyalgia

In brief

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.

Key facts

Study ID

NCT01432236

Run by

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

People needed

197

Starts

2011-10-01

Expected to finish

2013-07-01

Last updated by the study team

2021-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Genova Clinical Research — Tucson, Arizona, United States
• SDS Clinical Trials — Orange, California, United States
• Research Across America — Santa Ana, California, United States
• Innovative Research of West Florida, Inc. — Clearwater, Florida, United States
• Florida Medical Center & Research, Inc. — Coral Gables, Florida, United States
• Meridien Research — Tampa, Florida, United States
• Medical Research and Health Education Foundation, Inc. — Columbus, Georgia, United States
• Heartland Research Associates, LLC — Wichita, Kansas, United States
• Central Kentucky Research Associates, Inc. — Lexington, Kentucky, United States
• Boston Clinical Trials — Boston, Massachusetts, United States
• Michigan Head Pain and Neurological Institute — Ann Arbor, Michigan, United States
• Quality Clinical Research, Inc. — Omaha, Nebraska, United States
• Social Psychiatry Research Institute — Brooklyn, New York, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Radiant Research, Inc. — Columbus, Ohio, United States
• Midwest Clinical Research Center — Dayton, Ohio, United States
• Sunstone Medical Research, LLC — Medford, Oregon, United States
• Behavioral Medicine Center — Wyomissing, Pennsylvania, United States
• Clinical Research Center of Reading, LLP — Wyomissing, Pennsylvania, United States
• Coastal Medical — East Greenwich, Rhode Island, United States
• Omega Medical Research — Warwick, Rhode Island, United States
• Coastal Carolina Research Center — Mt. Pleasant, South Carolina, United States
• FutureSearch Trials of Neurology — Austin, Texas, United States
• Fatigue Consultation Clinic — Salt Lake City, Utah, United States
• Lifetree Clinical Research, LC — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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