Clinical Trial: Fluoxetine in Multiple System Atrophy Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: University Hospital, Toulouse

Current Primary Outcome: primary efficacy endpoint [ Time Frame: 3 months ]

The primary efficacy endpoint is the comparison of scores in Parts I and II of the UMSARS scale between the visit V0 and V2 (i.e. after 3 months of treatment at the dose of 40mg/day).


Original Primary Outcome: Same as current

Current Secondary Outcome: secondary efficacy endpoints [ Time Frame: 6 weeks, 3 months or 6 months ]

  • comparison of scores in Parts I and II of the UMSARS scale between the visit V0 and V3, i.e. after 6 months of treatment at the dose of 40mg/d
  • comparison of scores in Parts I and II of the UMSARS scale between the visit V0 and V1, i.e. after 6 weeks of treatment at the dose of 20mg/d
  • rate of mortality
  • score of SCOPA AUT scale - assessment of symptomes related to the dysautonomic affect
  • score of Part III of UMSARS scale - assessment of orthostatic hypotension
  • score of Beck scale - assessment of depression
  • score of Schrag scale - assessment of health-related quality of life


Original Secondary Outcome: Same as current

Information By: University Hospital, Toulouse

Dates:
Date Received: June 16, 2010
Date Started: May 2008
Date Completion:
Last Updated: March 25, 2015
Last Verified: February 2012