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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01136213 |
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Date of registration:
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26/05/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Investigation of the Serotoninergic System in Multiple System Atrophy: a Positron Emission Tomography (PET) Study
SEROTAMS |
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Scientific title:
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Morphological and Functional Investigation of the Serotoninergic System in Multiple System Atrophy: a 18F-MPPF PET Study |
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Date of first enrolment:
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April 2010 |
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Target sample size:
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53 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01136213 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Igor SIBON, Pr |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Bordeaux (France) |
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Name:
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Geneviève CHENE, Pr |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Bordeaux (France) |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with Multiple system atrophy (MSA)
- MSA possible or probable
- Male and female
- Age : 30 to 80
- No cognitive impairment
- Unmodified treatment for 2 months
- Able to give informed consent
- Affiliated to social insurance
- Patients with idiopathic Parkinson's disease (IPD):
- Positive clinical criteria for IPD
- Male and female
- Age : 30 to 80
- No cognitive impairment
- Unmodified treatment for 2 months
- Able to give informed consent
- Affiliated to social insurance
- Healthy controls:
- Absence of neuropsychiatric disorder
- Male and female
- Age : 30 to 80
- Able to give informed consent
- Affiliated to social insurance
Exclusion Criteria:
- Patients with Multiple system atrophy (MSA)
- Other Parkinsonian syndrome
- Dementia
- Recent intake (< 4 weeks or 8 weeks for fluoxetine) of medication acting on
5-HT1a receptors
- History of major depression
- Contraindication to brain MRI
- Contraindication to PET
- Patients with idiopathic Parkinson's disease
- Other Parkinsonian syndrome
- Dementia
- Recent intake (< 4 weeks or 8 weeks for fluoxetine) of medication acting on
5-HT1a receptors
- History of major depression
- Contraindication to brain MRI
- Contraindication to PET
- Healthy controls:
- Patient having a neuropsychiatric disease
- Recent intake (< 4 weeks or 8 weeks for fluoxetine) of medication acting on
5-HT1a receptors
- History of major depression
- Contraindication to brain MRI
- Contraindication to PET
Age minimum:
30 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple System Atrophy
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Intervention(s)
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Drug: Fluoxétine / Placebo
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Other: Brain MRI (magnetic resonance imaging)
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Radiation: PET (Positron Emission Tomography) Study
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Primary Outcome(s)
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18F-MPPF binding potential - Biding potential (BP) under placebo in the raphe nucleus
[Time Frame: Second visit (day 1)]
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Secondary Outcome(s)
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18F-MPPF binding potential - BP under fluoxetine in all brain areas
[Time Frame: Third visit (day 30)]
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18F-MPPF binding potential - Biding potential (BP) under placebo in other brain areas
[Time Frame: Third visit (day 30)]
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18F-MPPF binding potential - Biding potential (BP) in other brain areas
[Time Frame: Second visit (day 1)]
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Clinical parameters (motor handicap, orthostatic hypotension, quality of life, sleep, pain, tiredness)
[Time Frame: Third visit (day 30)]
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Clinical parameters (motor handicap, orthostatic hypotension, quality of life, sleep, pain, tiredness)
[Time Frame: Second visit (day 1)]
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Secondary ID(s)
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CHUBX 2008/01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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