Body Dysmorphic DisordersNCT02524301
Evaluation of Brain Opioid Receptor Activity in Anorexia Nervosa : a PET [11C]Diprenorphine Study
A study testing Positron Emission Tomography using [11C]diprenorphine in people with Body Dysmorphic Disorders and Anorexia, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.
Trial summary
The place of opioid system in anorexia nervosa (AN) physiopathology is still unclear. Conflicting results were published on cerebral spinal fluid or peripheral levels in anorexia nervosa. However, no data have been reported on opioid cerebral activity. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Dysmorphic Disorders, Anorexia
- What is being tested?
- Positron Emission Tomography using [11C]diprenorphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 3 sitesFrance
- Study dates
- Sep 2009to 29 Jul 2016
- Phase
- Interventional
- 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 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- AN patients DSM IV criteria including amenorrhea BMI < 17.5 kg/m² and abnormal nutritional markers Group 1 (N=15) : long period of / recurrent weight loss (> 2 yrs) Group 2 (N=15) : recent weight loss (6 to 12 months)
- Recovered AN patients History of AN Weight recovery and BMI > 18.5 kg/m², stable for at least 12 months Normal nutritional markers Group 1 (N=15) : menses recovery after bodyweight stabilization Group 2 (N=15) : long persistence of amenorrhea (> 12 months) despite weight recovery
- Healthy volunteers (N=15) BMI between 18.5 and 25 kg/m², normal nutritional markers, absence of psychiatric or organic pathology
- For all subjects Women 18-35 yrs Written and sign consent Affiliation to health insurance
Who cannot join
- History of heart failure
- Psychotropic treatment , antiepileptics
- Ongoing or suspected pregnancy, positive beta HCG test before brain imaging
- Intense physical activity
- Constrains for MRI (ferromagnetic implants or claustrophobia)
- Refusal to be informed in case of incidentaloma revealed by brain imaging
- Refusal for written consent
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU Clermont Ferrand
Clermont-Ferrand
CNRH
Clermont-Ferrand
CHU Saint-Etienne
Saint-Etienne, 42055
About this study
The place of opioid system in anorexia nervosa (AN) physiopathology is still unclear. Conflicting results were published on cerebral spinal fluid or peripheral levels in anorexia nervosa. However, no data have been reported on opioid cerebral activity. Diprenorphine is a ligand with non-selective binding to opiate receptors µ, κ and δ capable to assess the interaction between endogenous opioids and their receptors.
- Conditions
- Body Dysmorphic Disorders, Anorexia
- Being tested
- Positron Emission Tomography using [11C]diprenorphine
- Keywords
- anorexia nervosa, opioid receptors, Positron emission tomography (PET), diprenorphine
- Medical subject headings
- Body Dysmorphic Disorders, Anorexia, Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positron Emission Tomography using [11C]diprenorphineDrug
Also called PET
PET using [11C]diprenorphine
| Study group | Role | What they receive |
|---|---|---|
| anorexia nervosa patients | Experimental | Cerebral [11C]diprenorphine Binding Potential measured by Positron emission Tomography (PET) Receives: Drug: Positron Emission Tomography using [11C]diprenorphine |
| Recovered anorexia nervosa patients | Experimental | Cerebral [11C]diprenorphine Binding Potential measured by Positron emission Tomography (PET) Receives: Drug: Positron Emission Tomography using [11C]diprenorphine |
| Healthy Volonteers | Experimental | Cerebral [11C]diprenorphine Binding Potential measured by Positron emission Tomography (PET) Receives: Drug: Positron Emission Tomography using [11C]diprenorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
[11C]diprenorphine binding potential
Value of [11C]diprenorphine binding potential (BP) in predefined brains regions [11C] diprenorphine BP will be evaluated by brain positron emission tomography
Measured: week 2
Secondary outcomes (4)
Correlation [11C]diprenorphine binding potential
Correlation between [11C]diprenorphine binding potential and plasma endogenous opioid levels
Measured: week 2
Correlation [11C]diprenorphine binding potential
Correlation between [11C]diprenorphine binding potential and psychometric score evaluating addictive behavior, reward and positive reinforcement
Measured: week 2
Correlation [11C]diprenorphine binding potential
Correlation between [11C]diprenorphine binding potential and appetite regulating hormones
Measured: week 2
Correlation [11C]diprenorphine binding potential
Correlation between [11C]diprenorphine binding potential and LH response during GnRH test
Measured: week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startSep 2009
- Primary completion28 Jul 2016
- Study completion29 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body Dysmorphic DisordersStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Bruno Estour, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524301
- Sponsor's protocol ID
- 0908019
- Status last verified
- Oct 2018
- First submitted
- 12 Aug 2015
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Galusca B, Traverse B, Costes N, Massoubre C, Le Bars D, Estour B, Germain N, Redoute J. Decreased cerebral opioid receptors availability related to hormonal and psychometric profile in restrictive-type anorexia nervosa. Psychoneuroendocrinology. 2020 Aug;118:104711. doi: 10.1016/j.psyneuen.2020.104711. Epub 2020 May 19.
PubMed 32460196
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Brain Opioid Receptor Activity in Anorexia Nervosa : a PET [11C]Diprenorphine Study
- ClinicalTrials.gov ID
- NCT02524301
- Acronym / sponsor ID
- 0908019
- Conditions
- Body Dysmorphic Disorders, Anorexia
- Keywords
- anorexia nervosa, opioid receptors, Positron emission tomography (PET), diprenorphine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Sep 2009 (actual)
- Primary completion
- 28 Jul 2016 (actual)
- Study completion
- 29 Jul 2016 (actual)
- First posted
- 14 Aug 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.
The place of opioid system in anorexia nervosa (AN) physiopathology is still unclear. Conflicting results were published on cerebral spinal fluid or peripheral levels in anorexia nervosa. However, no data have been reported on opioid cerebral activity. Diprenorphine is a ligand with non-selective binding to opiate receptors µ, κ and δ capable to assess the interaction between endogenous opioids and their receptors.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| anorexia nervosa patients | Experimental | Drug: Positron Emission Tomography using [11C]diprenorphineCerebral [11C]diprenorphine Binding Potential measured by Positron emission Tomography (PET) |
| Recovered anorexia nervosa patients | Experimental | Drug: Positron Emission Tomography using [11C]diprenorphineCerebral [11C]diprenorphine Binding Potential measured by Positron emission Tomography (PET) |
| Healthy Volonteers | Experimental | Drug: Positron Emission Tomography using [11C]diprenorphineCerebral [11C]diprenorphine Binding Potential measured by Positron emission Tomography (PET) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- AN patients DSM IV criteria including amenorrhea BMI < 17.5 kg/m² and abnormal nutritional markers Group 1 (N=15) : long period of / recurrent weight loss (> 2 yrs) Group 2 (N=15) : recent weight loss (6 to 12 months)
- Recovered AN patients History of AN Weight recovery and BMI > 18.5 kg/m², stable for at least 12 months Normal nutritional markers Group 1 (N=15) : menses recovery after bodyweight stabilization Group 2 (N=15) : long persistence of amenorrhea (> 12 months) despite weight recovery
- Healthy volunteers (N=15) BMI between 18.5 and 25 kg/m², normal nutritional markers, absence of psychiatric or organic pathology
- For all subjects Women 18-35 yrs Written and sign consent Affiliation to health insurance
Key exclusion criteria (7 listed)
- History of heart failure
- Psychotropic treatment , antiepileptics
- Ongoing or suspected pregnancy, positive beta HCG test before brain imaging
- Intense physical activity
- Constrains for MRI (ferromagnetic implants or claustrophobia)
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 |
|---|---|---|
| Positron Emission Tomography using [11C]diprenorphineAlso: PETPET using [11C]diprenorphine | Drug | Healthy Volonteers, Recovered anorexia nervosa patients, anorexia nervosa patients |
Primary outcome
[11C]diprenorphine binding potential
Time frame: week 2
Value of [11C]diprenorphine binding potential (BP) in predefined brains regions [11C] diprenorphine BP will be evaluated by brain positron emission tomography
4 secondary outcomes
Correlation [11C]diprenorphine binding potential
Time frame: week 2
Correlation [11C]diprenorphine binding potential
Time frame: week 2
Correlation [11C]diprenorphine binding potential
Time frame: week 2
Correlation [11C]diprenorphine binding potential
Time frame: week 2
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 29 Oct 2018.
- Derived from this study: PubMed 32460196Galusca B, Traverse B, Costes N, Massoubre C, Le Bars D, Estour B, Germain N, Redoute J. Decreased cerebral opioid receptors availability related to hormonal and psychometric profile in restrictive-type anorexia nervosa. Psychoneuroendocrinology. 2020 Aug;118:104711. doi: 10.1016/j.psyneuen.2020.104711. Epub 2020 May 19.
- 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.
Bruno Estour, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positron Emission Tomography using [11C]diprenorphine in people with Body Dysmorphic Disorders and Anorexia, run by Centre Hospitalier Universitaire de Saint Etienne at 3 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 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
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?
[11C]diprenorphine binding potential (time frame: week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02524301, which also lists 1 linked publication.
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 29 Oct 2018.