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

U

University Hospital of Bordeaux

Status

Completed

Conditions

Multiple System Atrophy

Treatments

Radiation: PET (Positron Emission Tomography) Study
Other: Brain MRI (magnetic resonance imaging)
Drug: Fluoxétine / Placebo

Study type

Observational

Funder types

Other

Identifiers

NCT01136213
CHUBX 2008/01

Details and patient eligibility

About

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.

Enrollment

53 patients

Sex

All

Ages

30 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

53 participants in 3 patient groups

Multiple system atrophy
Treatment:
Drug: Fluoxétine / Placebo
Other: Brain MRI (magnetic resonance imaging)
Radiation: PET (Positron Emission Tomography) Study
Idiopathic Parkinson Disease
Treatment:
Drug: Fluoxétine / Placebo
Other: Brain MRI (magnetic resonance imaging)
Radiation: PET (Positron Emission Tomography) Study
Volunteers without neuropsychiatric disorder (Control)
Treatment:
Drug: Fluoxétine / Placebo
Other: Brain MRI (magnetic resonance imaging)
Radiation: PET (Positron Emission Tomography) Study

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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