NCT02524301

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2016

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2016

Completed
Last Updated

October 29, 2018

Status Verified

October 1, 2018

Enrollment Period

6.9 years

First QC Date

August 12, 2015

Last Update Submit

October 26, 2018

Conditions

Body Dysmorphic DisordersAnorexia

Keywords

anorexia nervosaopioid receptorsPositron emission tomography (PET)diprenorphine

Outcome Measures

Primary Outcomes (1)

  • [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 Outcomes (4)

  • Correlation [11C]diprenorphine binding potential

    week 2

  • Correlation [11C]diprenorphine binding potential

    week 2

  • Correlation [11C]diprenorphine binding potential

    week 2

  • Correlation [11C]diprenorphine binding potential

    week 2

Study Arms (3)

anorexia nervosa patients

EXPERIMENTAL

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

Drug: Positron Emission Tomography using [11C]diprenorphine

Recovered anorexia nervosa patients

EXPERIMENTAL

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

Drug: Positron Emission Tomography using [11C]diprenorphine

Healthy Volonteers

EXPERIMENTAL

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

Drug: Positron Emission Tomography using [11C]diprenorphine

Interventions

Positron Emission Tomography using [11C]diprenorphineDRUG

PET using \[11C\]diprenorphine

Also known as: PET
Healthy VolonteersRecovered anorexia nervosa patientsanorexia nervosa patients

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU Clermont Ferrand

Clermont-Ferrand, France

Location

CNRH

Clermont-Ferrand, France

Location

CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

Related Publications (1)

  • 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.

    PMID: 32460196DERIVED

MeSH Terms

Conditions

Body Dysmorphic DisordersAnorexiaAnorexia Nervosa

Condition Hierarchy (Ancestors)

Somatoform DisordersMental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding and Eating Disorders

Study Officials

  • Bruno Estour, PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2015

First Posted

August 14, 2015

Study Start

September 1, 2009

Primary Completion

July 28, 2016

Study Completion

July 29, 2016

Last Updated

October 29, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)