Clinical trial NCT02524301: Evaluation of Brain Opioid Receptor Activity in Anorexia Nervosa : a PET [11C]Diprenorphine Study
Official title: Evaluation of Brain Opioid Receptor Activity in Anorexia Nervosa : a PET [11C]Diprenorphine Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Dysmorphic Disorders
Anorexia
Keywords: anorexia nervosa
opioid receptors
Positron emission tomography (PET)
diprenorphine
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2015-08-14
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: [11C]diprenorphine binding potential
timeFrame: week 2
Secondary outcomes:
measure: Correlation [11C]diprenorphine binding potential
timeFrame: week 2
measure: Correlation [11C]diprenorphine binding potential
timeFrame: week 2
measure: Correlation [11C]diprenorphine binding potential
timeFrame: week 2
measure: Correlation [11C]diprenorphine binding potential
timeFrame: week 2
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont Ferrand
city: Clermont-Ferrand
country: France
facility: CNRH
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Bruno Estour, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.