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

Primary Purpose

Body Dysmorphic Disorders, Anorexia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Positron Emission Tomography using [11C]diprenorphine
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Body Dysmorphic Disorders focused on measuring anorexia nervosa, opioid receptors, Positron emission tomography (PET), diprenorphine

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • CHU Clermont Ferrand
  • CNRH
  • CHU Saint-Etienne

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

anorexia nervosa patients

Recovered anorexia nervosa patients

Healthy Volonteers

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

[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

Secondary Outcome Measures

Correlation [11C]diprenorphine binding potential
Correlation between [11C]diprenorphine binding potential and plasma endogenous opioid levels
Correlation [11C]diprenorphine binding potential
Correlation between [11C]diprenorphine binding potential and psychometric score evaluating addictive behavior, reward and positive reinforcement
Correlation [11C]diprenorphine binding potential
Correlation between [11C]diprenorphine binding potential and appetite regulating hormones
Correlation [11C]diprenorphine binding potential
Correlation between [11C]diprenorphine binding potential and LH response during GnRH test

Full Information

First Posted
August 12, 2015
Last Updated
October 26, 2018
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT02524301
Brief Title
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

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2009 (Actual)
Primary Completion Date
July 28, 2016 (Actual)
Study Completion Date
July 29, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Ministry of Health, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Dysmorphic Disorders, Anorexia
Keywords
anorexia nervosa, opioid receptors, Positron emission tomography (PET), diprenorphine

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
anorexia nervosa patients
Arm Type
Experimental
Arm Description
Cerebral [11C]diprenorphine Binding Potential measured by Positron emission Tomography (PET)
Arm Title
Recovered anorexia nervosa patients
Arm Type
Experimental
Arm Description
Cerebral [11C]diprenorphine Binding Potential measured by Positron emission Tomography (PET)
Arm Title
Healthy Volonteers
Arm Type
Experimental
Arm Description
Cerebral [11C]diprenorphine Binding Potential measured by Positron emission Tomography (PET)
Intervention Type
Drug
Intervention Name(s)
Positron Emission Tomography using [11C]diprenorphine
Other Intervention Name(s)
PET
Intervention Description
PET using [11C]diprenorphine
Primary Outcome Measure Information:
Title
[11C]diprenorphine binding potential
Description
Value of [11C]diprenorphine binding potential (BP) in predefined brains regions [11C] diprenorphine BP will be evaluated by brain positron emission tomography
Time Frame
week 2
Secondary Outcome Measure Information:
Title
Correlation [11C]diprenorphine binding potential
Description
Correlation between [11C]diprenorphine binding potential and plasma endogenous opioid levels
Time Frame
week 2
Title
Correlation [11C]diprenorphine binding potential
Description
Correlation between [11C]diprenorphine binding potential and psychometric score evaluating addictive behavior, reward and positive reinforcement
Time Frame
week 2
Title
Correlation [11C]diprenorphine binding potential
Description
Correlation between [11C]diprenorphine binding potential and appetite regulating hormones
Time Frame
week 2
Title
Correlation [11C]diprenorphine binding potential
Description
Correlation between [11C]diprenorphine binding potential and LH response during GnRH test
Time Frame
week 2

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Estour, PhD
Organizational Affiliation
CHU Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont Ferrand
City
Clermont-Ferrand
Country
France
Facility Name
CNRH
City
Clermont-Ferrand
Country
France
Facility Name
CHU Saint-Etienne
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32460196
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.
Results Reference
derived

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

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