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

Anorexia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02524301
• Other study ID #: 0908019
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: July 29, 2016

Study information

• Verified date: October 2018
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: July 29, 2016
• Est. primary completion date: July 28, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Body Dysmorphic Disorders

Intervention

Drug:
• Positron Emission Tomography using [11C]diprenorphine
PET using [11C]diprenorphine

Locations

Country	Name	City	State
France	CHU Clermont Ferrand	Clermont-Ferrand
France	CNRH	Clermont-Ferrand
France	CHU Saint-Etienne	Saint-Etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	[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	Correlation [11C]diprenorphine binding potential	Correlation between [11C]diprenorphine binding potential and plasma endogenous opioid levels	week 2
Secondary	Correlation [11C]diprenorphine binding potential	Correlation between [11C]diprenorphine binding potential and psychometric score evaluating addictive behavior, reward and positive reinforcement	week 2
Secondary	Correlation [11C]diprenorphine binding potential	Correlation between [11C]diprenorphine binding potential and appetite regulating hormones	week 2
Secondary	Correlation [11C]diprenorphine binding potential	Correlation between [11C]diprenorphine binding potential and LH response during GnRH test	week 2