Investigation of the Serotoninergic System in Multiple System Atrophy: a Positron Emission Tomography (PET) Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2016-03-31

Brief Summary

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Multiple system atrophy (MSA) is a sporadic neurodegenerative disorder of the adult associated to a poor prognosis. MSA is clinically characterized by the association of extra-pyramidal, dysautonomic, cerebellar and pyramidal symptoms. Histological and biological studies have raised the hypothesis that, beside the well known dopamine deficiency, some of the symptoms could be related to a dysfunction in serotoninergic neurotransmission. Serotonin is involved in the modulation of several functions impaired in MSA, such as mood, motricity or sleep. The recent description of an association between loss of brainstem serotonin neurons and sudden death in patients with MSA reinforced the hypothesis of a critical role played by this neurotransmitter in the pathophysiology of this disease. Autoreceptors called 5-HT1a are strongly involved in the regulation of serotonin neurotransmission. During the last years several radio-ligands allowing in vivo PET quantification of 5-HT1a receptors, such as 18F-MPPF (4-(2'-methoxyphenyl)-1-\[2'-(N-2''-piridinyl)-p-fluorobenzamide\]methylpiperazine), were developed. Moreover, the investigators recently demonstrated the ability of this brain functional imaging method to investigate, in healthy volunteers, the functional properties of 5-HT1a autoreceptors through an evaluation of their desensitization after a single oral dose of fluoxetine.

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Detailed Description

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Conditions

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Multiple System Atrophy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Multiple system atrophy

PET (Positron Emission Tomography) Study

Intervention Type RADIATION

5-HT1a auto-receptors will be visualized in vivo using 18F-MPPF PET study. Two PET studies will be performed, one after the intake of a single oral dose of fluoxetine and the other after placebo. The order of fluoxetine and placebo intake will be randomly assigned.

Brain MRI (magnetic resonance imaging)

Intervention Type OTHER

A brain MRI (magnetic resonance imaging)will be performed the day of the first PET study.

Fluoxétine / Placebo

Intervention Type DRUG

The two PET studies will be performed, one after the intake of a single oral dose of fluoxetine and the other after placebo. The order of fluoxetine and placebo intake will be randomly assigned.

Idiopathic Parkinson Disease

PET (Positron Emission Tomography) Study

Intervention Type RADIATION

5-HT1a auto-receptors will be visualized in vivo using 18F-MPPF PET study. Two PET studies will be performed, one after the intake of a single oral dose of fluoxetine and the other after placebo. The order of fluoxetine and placebo intake will be randomly assigned.

Brain MRI (magnetic resonance imaging)

Intervention Type OTHER

A brain MRI (magnetic resonance imaging)will be performed the day of the first PET study.

Fluoxétine / Placebo

Intervention Type DRUG

The two PET studies will be performed, one after the intake of a single oral dose of fluoxetine and the other after placebo. The order of fluoxetine and placebo intake will be randomly assigned.

Volunteers without neuropsychiatric disorder (Control)

PET (Positron Emission Tomography) Study

Intervention Type RADIATION

5-HT1a auto-receptors will be visualized in vivo using 18F-MPPF PET study. Two PET studies will be performed, one after the intake of a single oral dose of fluoxetine and the other after placebo. The order of fluoxetine and placebo intake will be randomly assigned.

Brain MRI (magnetic resonance imaging)

Intervention Type OTHER

A brain MRI (magnetic resonance imaging)will be performed the day of the first PET study.

Fluoxétine / Placebo

Intervention Type DRUG

The two PET studies will be performed, one after the intake of a single oral dose of fluoxetine and the other after placebo. The order of fluoxetine and placebo intake will be randomly assigned.

Interventions

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PET (Positron Emission Tomography) Study

5-HT1a auto-receptors will be visualized in vivo using 18F-MPPF PET study. Two PET studies will be performed, one after the intake of a single oral dose of fluoxetine and the other after placebo. The order of fluoxetine and placebo intake will be randomly assigned.

Intervention Type RADIATION

Brain MRI (magnetic resonance imaging)

A brain MRI (magnetic resonance imaging)will be performed the day of the first PET study.

Intervention Type OTHER

Fluoxétine / Placebo

The two PET studies will be performed, one after the intake of a single oral dose of fluoxetine and the other after placebo. The order of fluoxetine and placebo intake will be randomly assigned.

Intervention Type DRUG

Eligibility 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

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes