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NCT Number: NCT01136213

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

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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Key information

Conditions

Multiple System Atrophy Autonomic Nervous System Diseases Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Primary Dysautonomias Synucleinopathies

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux, Bordeaux, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PET (Positron Emission Tomography) Study

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)

Other

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

Fluoxétine / Placebo

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.

Primary outcomes

  1. 18F-MPPF binding potential - Biding potential (BP) under placebo in the raphe nucleus

    Time frame: Second visit (day 1)

    Amount of 5-HT1a autoreceptors (evaluated by measurement of 18F-MPPF binding potential) after intake of placebo in the raphe nucleus.

Secondary outcomes

  1. 18F-MPPF binding potential - Biding potential (BP) in other brain areas

    Time frame: Second visit (day 1)

    Amount of 5-HT1a autoreceptors (evaluated by measurement of 18F-MPPF binding potential) in other brain areas (brainstem, hippocampus, etc.)

  2. Clinical parameters (motor handicap, orthostatic hypotension, quality of life, sleep, pain, tiredness)

    Time frame: Second visit (day 1)

  3. 18F-MPPF binding potential - Biding potential (BP) under placebo in other brain areas

    Time frame: Third visit (day 30)

    Amount of 5-HT1a autoreceptors (evaluated by measurement of 18F-MPPF binding potential) after intake of placebo in other brain areas (brainstem, hippocampus, etc.).

  4. 18F-MPPF binding potential - BP under fluoxetine in all brain areas

    Time frame: Third visit (day 30)

    Amount of 5-HT1a autoreceptors (evaluated by measurement of 18F-MPPF binding potential - BP) after intake of fluoxetine in all brain areas.

  5. Clinical parameters (motor handicap, orthostatic hypotension, quality of life, sleep, pain, tiredness)

    Time frame: Third visit (day 30)

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Morphological and Functional Investigation of the Serotoninergic System in Multiple System Atrophy: a 18F-MPPF PET Study

Acronym: SEROTAMS

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Jun 3, 2010
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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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