Cannabinoid CB1 receptor agonist treatmentin severe chronic anorexia nervosa

Phase 1

• Conditions: severe chronic Anorexia Nervosa; MedDRA version: 9.1Level: PTClassification code 10002649Term: Anorexia nervosa

• Registration Number: EUCTR2007-005631-29-DK
• Lead Sponsor: Center for Spiseforstyrrelse, Endokrinologisk Afdeling M, Odense Universitetshospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-12
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1Patients under treatment for AN.
2Patients attending ambulatory treatment, which are not expected to be admitted at the hospital with AN-related pathology or discharged during the study period.
3Patients admitted to Department of Endocrinology M or Psychiatric department P which are not expected to be discharged during the study period.
4Age over 18.
5Duration of the disease over 5 years.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1Patients under compulsory treatment or suffering of mania, schizophrenia or primary depression.
2Patients with any medical or psychiatric event related or not related to the underlying eating disorder which requires prolonged admission to the hospital during the study.
3Patients with unstable heart disease (relevant changes in medication prior or during the study) and limitation of activity (not comfortable with more than moderate exertion / at rest).
4Patients not attending to the weekly controls.
5If other severe adverse events (SAE) / drug reactions (SADR) are suspected.
6Patients actually having or having a history of alcohol, cannabis, opioids or central stimulating drugs abuse.
7Patients with known allergy to dronabinol or sesam oil.
8Fertile, menstruating women not using safe contraception*.
9Pregnancy.

* - Patients with chronic AN have per definition amenorrhea and seldom vita sexualis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified