Fluoxetine
Drug20mg/d, oral administration for 6 weeks, then 40mg/d for 4 months.
Other names: PROZAC®
NCT Number: NCT01146548
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.
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Notify Me30 year–80 year
All sexes
Interventional
Phase 2
Hospital, Nantes, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
20mg/d, oral administration for 6 weeks, then 40mg/d for 4 months.
Other names: PROZAC®
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).
Time frame: 6 weeks, 3 months or 6 months
University Hospital, Toulouse
Other
Assessment of Fluoxetine's Effect in Patients With Multiple System Atrophy : a Double Blind Placebo-controlled Randomized Trial
Acronym: MSA-Fluox
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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