Trial record 3 of 18 for:
"multiple system atrophy" | Open Studies
Investigation of the Serotoninergic System in Multiple System Atrophy: a Positron Emission Tomography (PET) Study (SEROTAMS)
This study is currently recruiting participants.
Verified January 2013 by University Hospital, Bordeaux
Sponsor:
University Hospital, Bordeaux
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01136213
First received: May 26, 2010
Last updated: January 17, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Multiple System Atrophy |
Radiation: PET (Positron Emission Tomography) Study Other: Brain MRI (magnetic resonance imaging) Drug: Fluoxétine / Placebo |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | Morphological and Functional Investigation of the Serotoninergic System in Multiple System Atrophy: a 18F-MPPF PET Study |
Resource links provided by NLM:
Further study details as provided by University Hospital, Bordeaux:
Primary Outcome Measures:
- 18F-MPPF binding potential - Biding potential (BP) under placebo in the raphe nucleus [ Time Frame: Second visit (day 1) ] [ Designated as safety issue: No ]Amount of 5-HT1a autoreceptors (evaluated by measurement of 18F-MPPF binding potential) after intake of placebo in the raphe nucleus.
Secondary Outcome Measures:
- 18F-MPPF binding potential - Biding potential (BP) in other brain areas [ Time Frame: Second visit (day 1) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]
- 18F-MPPF binding potential - Biding potential (BP) under placebo in other brain areas [ Time Frame: Third visit (day 30) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 54 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Multiple system atrophy |
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.
|
| Idiopathic Parkinson Disease |
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.
|
| Volunteers without neuropsychiatric disorder (Control) |
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.
|
Eligibility| Ages Eligible for Study: | 30 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients will be recruited by neurologists specialized in movement disorders
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01136213
Contacts
| Contact: Igor SIBON, Pr | 05 56 79 55 20 | igor.sibon@chu-bordeaux.fr |
| Contact: Sylvain LEDURE | 05 56 79 55 20 | sylvain.ledure@chu-bordeaux.fr |
Locations
| France | |
| CHU de Bordeaux | Recruiting |
| Bordeaux, France, 33076 | |
| Contact: Igor SIBON, Pr 05 56 79 55 20 igor.sibon@chu-bordeaux.fr | |
| Sub-Investigator: François TISON, Pr | |
| Sub-Investigator: Wassilios MEISSNER, Dr | |
| Sub-Investigator: Michèle ALLARD, Pr | |
| Sub-Investigator: Olivier FLABEAU, PH | |
| CHU Limoges | Not yet recruiting |
| Limoges, France | |
| Contact: Philippe COURATIER, PH PU | |
| Principal Investigator: Philippe COURATIER, Pr | |
| Sub-Investigator: Frédéric TORNY, Dr | |
| CHU de Toulouse | Recruiting |
| Toulouse, France, 31059 | |
| Contact: Olivier RASCOL, Pr rascol@cict.fr | |
| Principal Investigator: Olivier RASCOL, Pr | |
| Sub-Investigator: Anne PAVY-LE TRAON, Dr | |
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
| Principal Investigator: | Igor SIBON, Pr | University Hospital Bordeaux (France) |
| Study Chair: | Geneviève CHENE, Pr | University Hospital Bordeaux (France) |
More Information
No publications provided
| Responsible Party: | University Hospital, Bordeaux |
| ClinicalTrials.gov Identifier: | NCT01136213 History of Changes |
| Other Study ID Numbers: | CHUBX 2008/01 |
| Study First Received: | May 26, 2010 |
| Last Updated: | January 17, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Multiple System Atrophy Shy-Drager Syndrome Atrophy Primary Dysautonomias Autonomic Nervous System Diseases Nervous System Diseases Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Neurodegenerative Diseases Hypotension Vascular Diseases Cardiovascular Diseases |
Pathological Conditions, Anatomical Fluoxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013