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

Not Applicable

Completed

• Conditions: Anorexia; Body Dysmorphic Disorders
• Interventions: Drug: Positron Emission Tomography using [11C]diprenorphine

• Registration Number: NCT02524301
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2015-08-12
• Study First Submitted QC: 2015-08-13
• Study First Posted: 2015-08-14
• Primary Completion: 2016-07-28
• Study Completion: 2016-07-29
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-26
• Last Update Posted: 2018-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Volonteers	Positron Emission Tomography using [11C]diprenorphine	Cerebral \[11C\]diprenorphine Binding Potential measured by Positron emission Tomography (PET)
anorexia nervosa patients	Positron Emission Tomography using [11C]diprenorphine	Cerebral \[11C\]diprenorphine Binding Potential measured by Positron emission Tomography (PET)
Recovered anorexia nervosa patients	Positron Emission Tomography using [11C]diprenorphine	Cerebral \[11C\]diprenorphine Binding Potential measured by Positron emission Tomography (PET)

Primary Outcome Measures

Name	Time	Method
[11C]diprenorphine binding potential	week 2	Value of \[11C\]diprenorphine binding potential (BP) in predefined brains regions \[11C\] diprenorphine BP will be evaluated by brain positron emission tomography

Secondary Outcome Measures

Name	Time	Method
Correlation [11C]diprenorphine binding potential	week 2	Correlation between \[11C\]diprenorphine binding potential and LH response during GnRH test

Trial Locations

Locations (3)

CHU Clermont Ferrand; 🇫🇷 Clermont-Ferrand, France

CNRH; 🇫🇷 Clermont-Ferrand, France

CHU Saint-Etienne; 🇫🇷 Saint-Etienne, France