- 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.
- 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
- 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