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

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study was designed to investigate whether milnacipran is safe and effective in improving cognitive function in fibromyalgia. In addition, this study was aimed to investigate whether improvement in neurocognitive status due to milnacipran correlates with improvements in pain, to investigate whether improvement in neurocognitive status due to milnacipran correlates with improvements in fatigue, and to determine whether treatment with improvement in neurocognitive status, pain and fatigue correlates with functional improvement.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: Forest Laboratories
• Treatments: Levomilnacipran; Milnacipran

Criteria

Inclusion Criteria:

• Age 18 to 65 years.

• Specific diagnosis of FM by the participant's rheumatologist or physician, including written confirmation, from a physician, of the FM diagnosis.

• Confirmation of the FM diagnosis by American College of Rheumatology Criteria and a physical tender point examination.

• Ability to give informed consent.

• If female, nonpregnant/nonlactating.

• If a sexually active female of reproductive potential, must be using adequate contraception (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 rheumatoid arthritis, systemic lupus erythematosus, Hashimoto's disease, Sjogren's syndrome or scleroderma.

• 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 clinically significant by the investigator.

• History of hypersensitivity to milnacipran.

• Seizure disorder, traumatic brain injury, any CNS disorder that affects cognitive status.

• Concomitant meds: A minimum of 30 days on stable dose of analgesics and a minimum of 4 week washout from antidepressants and fibromyalgia specific medication ( e.g. pregabalin, neurontin) and supplements ( St John's wort, SAM-E).

• Narrow angle glaucoma.