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

Viatris

Status and phase

Completed

Phase 3

Conditions

Fibromyalgia

Treatments

Drug: placebo

Drug: Pregabalin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01432236

2011-002480-19 (EudraCT Number)

A0081275

Details and patient eligibility

About

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.

Enrollment

197 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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