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

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ClinicalTrials.gov Identifier: NCT01136213
Recruitment Status : Completed
First Posted : June 3, 2010
Last Update Posted : August 4, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Tracking Information
First Submitted Date May 26, 2010
First Posted Date June 3, 2010
Last Update Posted Date August 4, 2017
Actual Study Start Date April 2010
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 21, 2010)
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.
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01136213 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 17, 2013)
  • 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.)
  • Clinical parameters (motor handicap, orthostatic hypotension, quality of life, sleep, pain, tiredness) [ Time Frame: Second visit (day 1) ]
  • 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.).
  • 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.
  • Clinical parameters (motor handicap, orthostatic hypotension, quality of life, sleep, pain, tiredness) [ Time Frame: Third visit (day 30) ]
Original Secondary Outcome Measures
 (submitted: June 2, 2010)
  • 18F-MPPF binding potential - BP under placebo in other brain areas [ Time Frame: Second (day 1) or third visit (day 30) ]
    Amount of 5-HT1a autoreceptors (evaluated by measurement of 18F-MPPF binding potential - BP) after intake of placebo in other brain areas (brainstem, hyppocampus, etc.).
  • 18F-MPPF binding potential - BP under fluoxetine in all brain areas [ Time Frame: Second (day 1) or 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.
  • Clinical parameters (motor handicap, orthostatic hypotension, quality of life, sleep, pain, tiredness) [ Time Frame: Second (day 1) and third visit (day 30) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Investigation of the Serotoninergic System in Multiple System Atrophy: a Positron Emission Tomography (PET) Study
Official Title Morphological and Functional Investigation of the Serotoninergic System in Multiple System Atrophy: a 18F-MPPF PET Study
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients will be recruited by neurologists specialized in movement disorders
Condition Multiple System Atrophy
Intervention
  • Radiation: 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.
  • Other: Brain MRI (magnetic resonance imaging)
    A brain MRI (magnetic resonance imaging)will be performed the day of the first PET study.
  • Drug: 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.
Study Groups/Cohorts
  • Multiple system atrophy
    Interventions:
    • Radiation: PET (Positron Emission Tomography) Study
    • Other: Brain MRI (magnetic resonance imaging)
    • Drug: Fluoxétine / Placebo
  • Idiopathic Parkinson Disease
    Interventions:
    • Radiation: PET (Positron Emission Tomography) Study
    • Other: Brain MRI (magnetic resonance imaging)
    • Drug: Fluoxétine / Placebo
  • Volunteers without neuropsychiatric disorder (Control)
    Interventions:
    • Radiation: PET (Positron Emission Tomography) Study
    • Other: Brain MRI (magnetic resonance imaging)
    • Drug: Fluoxétine / Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 3, 2017)
53
Original Estimated Enrollment
 (submitted: June 2, 2010)
54
Actual Study Completion Date March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01136213
Other Study ID Numbers CHUBX 2008/01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Bordeaux
Study Sponsor University Hospital, Bordeaux
Collaborators Not Provided
Investigators
Principal Investigator: Igor SIBON, Pr University Hospital Bordeaux (France)
Study Chair: Geneviève CHENE, Pr University Hospital Bordeaux (France)
PRS Account University Hospital, Bordeaux
Verification Date August 2017