The Effect of Milnacipran in Patients With Fibromyalgia
Use of the drug Milnacipran will reduce ventricular lactate levels and processing time for completing complex tasks relative to placebo.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Effect of Milnacipran or Placebo on Ventricular Lactate Levels and Fibromyalgia Induced "Brain Fog."|
- Ventricular lactate levels in the brain. [ Time Frame: 2 months ] [ Designated as safety issue: No ]Ventricular lactate levels will be assessed by a scanning method known as magnetic resonance spectroscopy (MRS), which is used to determine the presence and quantity of a number of chemicals in the brain.
- Cognitive function of simple motor and complex motor reflexes will be assessed via the Attention Network Test (ANT). [ Time Frame: 2 months ] [ Designated as safety issue: No ]The Attention Network Test (ANT) is a simple computerized test designed to evaluate the efficiency of the attentional networks involved in: alerting, orienting and executive attention.
|Study Start Date:||March 2010|
|Study Completion Date:||January 2014|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
|Active Comparator: Patients taking the drug Minalcipran||
Patients will take an increasing number of 12.5mg pills for the first 9 days during the "ramp up" period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study.
|Placebo Comparator: Patients taking the placebo||
Patients will take an increasing number of placebo pills for the first 9 days during the "ramp up" period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study.
Patients with Fibromyalgia will show elevated ventricular lactate levels as measured via magnetic resonance spectroscopy (MRS). Patients treated with Milnacipran will show normalization of ventricular lactate levels compared to those treated with placebo, and will also show normalization of the increased latency to respond to complex reaction time probes compared to those treated with placebo.
|United States, New York|
|Pain and Fatigue Study Center - Beth Israel Medical Center|
|New York, New York, United States, 10003|
|Principal Investigator:||Benjamin H Natelson, MD||Beth Israel Medical Center|