Milnacipran and Neurocognition, Pain and Fatigue in Fibromyalgia : A 13-week Randomized, Placebo Controlled Cross Over Trial

Inclusion Criteria:

• Age 18 to 65 years.
• Specific diagnosis of FM by the participant's rheumatologist or physician, includingwritten confirmation, from a physician, of the FM diagnosis.
• Confirmation of the FM diagnosis by American College of Rheumatology Criteria and aphysical tender point examination.
• Ability to give informed consent.
• If female, nonpregnant/nonlactating.
• If a sexually active female of reproductive potential, must be using adequatecontraception (i.e., oral contraceptives, barrier protection, or prior tubal ligation)during the trial.

Exclusion Criteria:

• Bipolar disorders, any psychotic disorder.
• the existence of concomitant rheumatological disorders, including rheumatoidarthritis, systemic lupus erythematosus, Hashimoto's disease, Sjogren's syndrome orscleroderma.
• Substance dependence (except nicotine dependence) in the previous 3 months.
• Currently suicidal or high suicide risk.
• Serious or unstable medical disorders.
• Any psychotropic drug treatment in the previous 2 weeks before screening.
• A positive urine pregnancy test.
• Screening laboratory values three times the limits of normal or judged clinicallysignificant by the investigator.
• History of hypersensitivity to milnacipran.
• Seizure disorder, traumatic brain injury, any CNS disorder that affects cognitivestatus.
• Concomitant meds: A minimum of 30 days on stable dose of analgesics and a minimum of 4week washout from antidepressants and fibromyalgia specific medication ( e.g.pregabalin, neurontin) and supplements ( St John's wort, SAM-E).
• Narrow angle glaucoma.