Evaluation of Brain Opioid Receptor Activity in Anorexia Nervosa : a PET [11C]Diprenorphine Study

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Brain Opioid Receptor Activity in Anorexia Nervosa : a PET [11C]Diprenorphine Study

Conditions
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Body Dysmorphic Disorders, Anorexia

Intervention / Treatment
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* Drug: Positron Emission Tomography using [11C]diprenorphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: anorexia nervosa patients<br>Cerebral [11C]diprenorphine Binding Potential measured by Positron emission Tomography (PET) | Drug: Positron Emission Tomography using [11C]diprenorphine<br>* PET using [11C]diprenorphine<br>* Other names: PET;|
| Experimental: Recovered anorexia nervosa patients<br>Cerebral [11C]diprenorphine Binding Potential measured by Positron emission Tomography (PET) | Drug: Positron Emission Tomography using [11C]diprenorphine<br>* PET using [11C]diprenorphine<br>* Other names: PET;|
| Experimental: Healthy Volonteers<br>Cerebral [11C]diprenorphine Binding Potential measured by Positron emission Tomography (PET) | Drug: Positron Emission Tomography using [11C]diprenorphine<br>* PET using [11C]diprenorphine<br>* Other names: PET;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| [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 | week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation [11C]diprenorphine binding potential | Correlation between [11C]diprenorphine binding potential and plasma endogenous opioid levels | week 2 | 
| Correlation [11C]diprenorphine binding potential | Correlation between [11C]diprenorphine binding potential and psychometric score evaluating addictive behavior, reward and positive reinforcement | week 2 | 
| Correlation [11C]diprenorphine binding potential | Correlation between [11C]diprenorphine binding potential and appetite regulating hormones | week 2 | 
| Correlation [11C]diprenorphine binding potential | Correlation between [11C]diprenorphine binding potential and LH response during GnRH test | week 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anorexia nervosa, opioid receptors, Positron emission tomography (PET), diprenorphine