Status:
COMPLETED
Milnacipran and Neurocognition, Pain and Fatigue in Fibromyalgia : A 13-week Randomized, Placebo Controlled Cross Over Trial
Lead Sponsor:
Duke University
Collaborating Sponsors:
Forest Laboratories
Conditions:
Fibromyalgia
Neurocognition
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 i...
Detailed Description
Cognitive dysfunction is observed in fibromyalgia, especially for episodic memory, learning, and working memory.There is evidence for dysregulation of the attention system from low-level sensory proce...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01829243
Start Date
July 1 2011
End Date
May 1 2013
Last Update
October 26 2023
Active Locations (1)
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1
Duke University Medical Center / Civitan Building
Durham, North Carolina, United States, 27705