Milnacipran and Neurocognition, Pain and Fatigue in Fibromyalgia : A 13-week Randomized, Placebo Controlled Cross Over Trial
Condition: Fibromyalgia; Neurocognition
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: Milnacipran; Placebo
Intervention MeSH terms: Milnacipran; Levomilnacipran
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Milnacipran; Fibromyalgia; Neurocognition

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.
    

Eligibility 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.