The Effect of Milnacipran in Patients With Fibromyalgia

Beth Israel Lahey Health

Status and phase: Completed; Phase 3; Phase 2

Conditions: Fibromyalgia

Treatments: Drug: Placebo; Drug: Milnacipran

Study type: Interventional

Funder types: Other

Identifiers

NCT01108731

BIMC #212-09

Details and patient eligibility

About

Use of the drug Milnacipran will reduce ventricular lactate levels and processing time for completing complex tasks relative to placebo.

Full description

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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 68 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female or male subjects who fulfill the American College of Rheumatology's case definition for Fibromyalgia.
• 18 through 68 years of age

Exclusion criteria

• Pregnant or trying to become pregnant
• Taking any other Serotonin Norepinephrine Reuptake Inhibitor (SNRI) or already taking milnacipran
• Patients who do not indicate their pain levels as less than substantial despite their best care
• History of any psychotic disorder or history of alcoholism or drug abuse within 10 years of intake as determined by psychiatric diagnostic interview
• Presence of current depression as determined by psychiatric diagnostic interview
• Presence of brain lesion on MRI anatomical study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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37 participants in 2 patient groups, including a placebo group

Patients taking the drug Milnacipran

Active Comparator group

Description:

Randomize patients signing informed consent and give 50% of them Milnacipran -- blinded to the investigators.

Treatment:

Drug: Milnacipran

Patients taking the placebo

Placebo Comparator group

Description:

Randomize patients signing informed consent and give 50% of them the placebo -- blinded to the investigators.

Treatment:

Drug: Placebo