Bulimia NervosaPhase 4NCT02359513
Evaluation of the Efficacy of Serotoninergic Antidepressants in Bulimia Nervosa, According to Brain Serotonin Profile Determined by Positron Emission Tomography With [18F] MPPF.
A Phase 4 study testing Antidepressants and Positron Emission Tomography (PET) in people with Bulimia Nervosa, run by Centre Hospitalier Universitaire de Saint Etienne at 4 sites in France.
Trial summary
Bulimia nervosa (BN) is a serious mental illness characterized by massive food crises followed by anxiety and compensatory behaviours (vomiting more often). Recent data show an increasing prevalence and a serious prognosis, due to excess mortality by suicide but also somatic complications. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bulimia Nervosa
- What is being tested?
- Antidepressants and Positron Emission Tomography (PET)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 4 sitesFrance
- Study dates
- 9 Nov 2015to 11 Mar 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient affiliated or entitled to a social security scheme
- Bulimic patients according to DSM-IV TR: minimum 2 bulimic crises (compulsive eating followed by compensatory behavior) / week for 3 weeks
- Patients who signed informed consent to the study
- BMI greater than or equal to 18.5 kg / m²
Who cannot join
- Against-indication to the SSRI or fluoxetine
- SSRI consumption in the previous three months
- Other addiction (except tobacco, for reasons of feasibility)
- Diagnosis of binge eating disorder or EDNOS (DSM-IV-TR)
- Patients with heart failure
- Against-indication for PET and / or MRI: pacemaker, intracerebral clips, prosthesis made of ferromagnetic material or claustrophobia
- Subjects with suspected pregnancy or in the second half of their menstrual cycle in the absence of oral contraceptives; positive Β-HCG test before the exam
Trial locations and contacts
4 sites in 1 country.
France4 sites
Groupement Hospitalier Est - HCL
Bron, 69678
CHU de Clermont-Ferrand
Clermont-Ferrand
CHU Grenoble
Grenoble, 38043
Chu Saint-Etienne
Saint-Etienne, 42055
About this study
Official title: Evaluation of the Efficacy of Serotoninergic Antidepressants in Bulimia Nervosa, According to Brain Serotonin Profile Determined by Positron Emission Tomography With [18F] MPPF - a Multicenter Study
Bulimia nervosa (BN) is a serious mental illness characterized by massive food crises followed by anxiety and compensatory behaviours (vomiting more often). Recent data show an increasing prevalence and a serious prognosis, due to excess mortality by suicide but also somatic complications.
Two types of treatments are validated : serotoninergic antidepressants (SSRI) and psychotherapy. Many clinical trials confirm the effectiveness of the SSRI. But many studies also emphasize the important proportion of non-responders to SSRI, few of them analyze the reasons for this non-answer.
Read more
To better understand the mode of action of SSRI, we should analyse the serotonergic activity in the central nervous system in bulimia. Recently, specific brain 5HT1A serotonin receptor ligands ([18F] MPPF or [11 C] WAY-100635), were used in positron emission tomography (PET) to characterize the serotonergic abnormalities of bulimic patients. The ligand [18F] MPPF has the feature to be sensitive to the level of endogenous serotonin.
A first pilot study using PET with [18F] MPPF realized between the University Hospital of Saint Etienne and Lyon CERMEP showed a diffuse increase of the binding potential of [18F] MPPF in bulimic patients, suggesting a decrease in serotonin activity.
The brain regions affected were angular gyrus, medial frontal cortex, left insula, cingulate gyrus and orbitofrontal gyrus. These areas are involved in major bulimic symptoms (impulse, taste, instinct, anxiety and satiety). However, we noticed an interindividual heterogeneity of cortical binding of [18F] MPPF.
In front of the heterogeneity in terms of efficacity of SSRI and brain serotoninergic activity, it seems necessary to continues investigations, to determine if there is a link between brain serotonin profile and responding to SSRI in bulimia nervosa.
- Conditions
- Bulimia Nervosa
- Being tested
- Antidepressants, Positron Emission Tomography (PET)
- Keywords
- bulimia, serotoninergic brain activity, fluoxetine, serotoninergic antidepressant, brain serotonin profile, positon emission tomography
- Medical subject headings
- Bulimia Nervosa, Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntidepressantsDrug
Also called Fluoxetine
bulimic patients are treated during 3 months
Positron Emission Tomography (PET)Drug
Also called PET scan
PET scan using [18F]MPPF is performed before and after (3 months)antidepressant treatment
| Study group | Role | What they receive |
|---|---|---|
| boulimic | Experimental | Analyse of serotoninergic brain activity (determined by positron emission tomography using [18F]MPPF) from bulimic patients treated with serotoninergic antidepressants during 3 months. The serotoninergic brain activity is measured before adnd after the serotoninergic antidepressant treatment. Receives: Drug: Antidepressants; Drug: Positron Emission Tomography (PET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between [18F]MPPF Binding Potential (BP) and efficacy of antidepressant treatment
Correlation between efficacy of antidepressant treatment quantified by change from the baseline in number of bulimic crises and the change from the baseline in [18F]MPPF BP at 3 months
Measured: 3 months
Secondary outcomes (3)
Correlation between [18F]MPPF Binding Potential (BP) and psychometric scores
Correlation between change from the baseline in [18F]MPPF BP and change from the baseline in psychometric scores at 3 months
Measured: 3 months
Correlation between [18F]MPPF Binding Potential (BP) and initial severity
Correlation between [18F]MPPF Binding Potential (BP) at 3 months and initial (month 0) disease severity quantified by numbers bulimic crises over last 2 weeks before the initial evaluation and psychometric scores at initial evaluation (day 0)
Measured: 3 months
Change from baseline in [18F]MPPF Binding Potential (BP)
Comparison between [18F]MPPF Binding Potential (BP) before antidepressant treatment (day 0) and after antidepressant treatment (month 3)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study start9 Nov 2015
- Primary completion12 Nov 2021
- Study completion11 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bulimia NervosaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Bogdan GALUSCA, MD, Principal investigator, CHU SAINT-ETIENNNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359513
- Sponsor's protocol ID
- 1408170
- Other IDs
- 2015-000365-31, 2015
- Status last verified
- Mar 2022
- First submitted
- 2 Feb 2015
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Serotoninergic Antidepressants in Bulimia Nervosa, According to Brain Serotonin Profile Determined by Positron Emission Tomography With [18F] MPPF - a Multicenter Study
- ClinicalTrials.gov ID
- NCT02359513
- Acronym / sponsor ID
- 1408170
- Conditions
- Bulimia Nervosa
- Keywords
- bulimia, serotoninergic brain activity, fluoxetine, serotoninergic antidepressant, brain serotonin profile, positon emission tomography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 9 Nov 2015 (actual)
- Primary completion
- 12 Nov 2021 (actual)
- Study completion
- 11 Mar 2022 (actual)
- First posted
- 10 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bulimia nervosa (BN) is a serious mental illness characterized by massive food crises followed by anxiety and compensatory behaviours (vomiting more often). Recent data show an increasing prevalence and a serious prognosis, due to excess mortality by suicide but also somatic complications.
Two types of treatments are validated : serotoninergic antidepressants (SSRI) and psychotherapy. Many clinical trials confirm the effectiveness of the SSRI. But many studies also emphasize the important proportion of non-responders to SSRI, few of them analyze the reasons for this non-answer.
To better understand the mode of action of SSRI, we should analyse the serotonergic activity in the central nervous system in bulimia. Recently, specific brain 5HT1A serotonin receptor ligands ([18F] MPPF or [11 C] WAY-100635), were used in positron emission tomography (PET) to characterize the serotonergic abnormalities of bulimic patients. The ligand [18F] MPPF has the feature to be sensitive to the level of endogenous serotonin.
A first pilot study using PET with [18F] MPPF realized between the University Hospital of Saint Etienne and Lyon CERMEP showed a diffuse increase of the binding potential of [18F] MPPF in bulimic patients, suggesting a decrease in serotonin activity.
The brain regions affected were angular gyrus, medial frontal cortex, left insula, cingulate gyrus and orbitofrontal gyrus. These areas are involved in major bulimic symptoms (impulse, taste, instinct, anxiety and satiety). However, we noticed an interindividual heterogeneity of cortical binding of [18F] MPPF.
In front of the heterogeneity in terms of efficacity of SSRI and brain serotoninergic activity, it seems necessary to continues investigations, to determine if there is a link between brain serotonin profile and responding to SSRI in bulimia nervosa.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| boulimic | Experimental | Drug: Antidepressants, Drug: Positron Emission Tomography (PET)Analyse of serotoninergic brain activity (determined by positron emission tomography using [18F]MPPF) from bulimic patients treated with serotoninergic antidepressants during 3 months. The serotoninergic brain activity is measured before adnd after the serotoninergic antidepressant treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient affiliated or entitled to a social security scheme
- Bulimic patients according to DSM-IV TR: minimum 2 bulimic crises (compulsive eating followed by compensatory behavior) / week for 3 weeks
- Patients who signed informed consent to the study
- BMI greater than or equal to 18.5 kg / m²
Key exclusion criteria (7 listed)
- Against-indication to the SSRI or fluoxetine
- SSRI consumption in the previous three months
- Other addiction (except tobacco, for reasons of feasibility)
- Diagnosis of binge eating disorder or EDNOS (DSM-IV-TR)
- Patients with heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntidepressantsAlso: Fluoxetinebulimic patients are treated during 3 months | Drug | boulimic |
| Positron Emission Tomography (PET)Also: PET scanPET scan using [18F]MPPF is performed before and after (3 months)antidepressant treatment | Drug | boulimic |
Primary outcome
Correlation between [18F]MPPF Binding Potential (BP) and efficacy of antidepressant treatment
Time frame: 3 months
Correlation between efficacy of antidepressant treatment quantified by change from the baseline in number of bulimic crises and the change from the baseline in [18F]MPPF BP at 3 months
3 secondary outcomes
Correlation between [18F]MPPF Binding Potential (BP) and psychometric scores
Time frame: 3 months
Correlation between [18F]MPPF Binding Potential (BP) and initial severity
Time frame: 3 months
Change from baseline in [18F]MPPF Binding Potential (BP)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bogdan GALUSCA, MD principal investigator
CHU SAINT-ETIENNNE
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antidepressants and Positron Emission Tomography (PET) in people with Bulimia Nervosa, run by Centre Hospitalier Universitaire de Saint Etienne at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between [18F]MPPF Binding Potential (BP) and efficacy of antidepressant treatment (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.