NCT01146548

Fluoxetine in Multiple System Atrophy Patients

Assessment of Fluoxetine's Effect in Patients With Multiple System Atrophy : a Double Blind Placebo-controlled Randomized Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a French national trial, conducted using a double-blind, placebo-controlled, randomised design involving 15 centers and 88 patients of both sexes. The primary objective of the trial is to evaluate the effect of a selective inhibitor of serotonin reuptake, the Fluoxétine, at a higher dose (40 mg/day) than usually recommended for depressed patients, after three months in patients suffering from an atypical Parkinson's disease called Multiple System Atrophy, compared to the placebo effect. Secondary objectives of the trial are the evaluation of the effects of Fluoxétine after six weeks at the dose of 20 mg/day, after six months at the dose of 40mg/day, and assess the effects on mortality, quality of life, autonomic disorders, particularly orthostatic hypotension, mood and others symptoms such as sleep, apathy, pain and fatigue.

Detailed description

Fluoxetine is first introduced in dose of 20 mg/day and after six weeks the dose is increased to 40 mg/day. If patients have side effects at the dose of 40 mg/day, the dose may be reduced at 20 mg/day. Assessment visits will be conducted at 6 weeks, 3 months, and 6 months of treatment. After 6 months, trial's treatment with fluoxetine is discontinued gradually. A new assessment will be conducted one month after the end of treatment. The expected results are the demonstration of improved scores of the scale UMSARS after 3 and 6 months in the fluoxetine group compared to the placebo group.

Conditions

• Multiple System Atrophy

Interventions

Type	Name	Description
DRUG	FLUOXETINE	20mg/d, oral administration for 6 weeks, then 40mg/d for 4 months.

Timeline

• Start date: 2008-05-01
• Primary completion: 2011-06-01
• Completion: 2011-09-01
• First posted: 2010-06-17
• Last updated: 2015-03-26

Locations

14 sites across 1 country: France