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Clinical Trials/NCT02524301
NCT02524301
Completed
Not Applicable

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

Centre Hospitalier Universitaire de Saint Etienne3 sites in 1 country53 target enrollmentSeptember 2009

Overview

Phase
Not Applicable
Intervention
Positron Emission Tomography using [11C]diprenorphine
Conditions
Body Dysmorphic Disorders
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
53
Locations
3
Primary Endpoint
[11C]diprenorphine binding potential
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
July 29, 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

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

Arms & Interventions

anorexia nervosa patients

Cerebral \[11C\]diprenorphine Binding Potential measured by Positron emission Tomography (PET)

Intervention: Positron Emission Tomography using [11C]diprenorphine

Recovered anorexia nervosa patients

Cerebral \[11C\]diprenorphine Binding Potential measured by Positron emission Tomography (PET)

Intervention: Positron Emission Tomography using [11C]diprenorphine

Healthy Volonteers

Cerebral \[11C\]diprenorphine Binding Potential measured by Positron emission Tomography (PET)

Intervention: Positron Emission Tomography using [11C]diprenorphine

Outcomes

Primary Outcomes

[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

Secondary Outcomes

  • Correlation [11C]diprenorphine binding potential(week 2)

Study Sites (3)

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