A medical treatment trial investigating whether degarelix decreases the risk of persons with pedophilic disorder from committing sexual child molestatio
- Conditions
- Pedophilia acccording to DSM-5 (F65.4)Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
- Registration Number
- EUCTR2014-000647-32-SE
- Lead Sponsor
- Karolinska University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 60
Male >= 18 -65 years
Diagnos pedophilia 302.2 according to DSM-5
Signed informed consent
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 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Diagnose of osteporosis
Extended QT/QTc ration on ECG (>450 ms)
Symptoms or riskfactors known to increase the risk for QT extension (e.g. a history or (family heridity) of cardiac events that indicate a prolongation of QT interval e.g. freqent attacs of syncopé, or propensity to ventricular tachyarrhythmias).
On current medical treatment with pharmaceutical substances that could increase QT interval.
Known liver disease/function
Known kidney disease/function
Severe asthma
Known allery to IMP and/or IMP excipients
Ongoing drugabuse, measured in AUDIT/DUDIT
Any indications that MRI measurement are contraindiciated (i.e. metal clips brain etc.)
Any other condition that could jepordize the trial scientificly or patients health, as judged by the investigator
Particiaption in another clincial trial
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: How safe is the substance to use?<br>Does riskfactors correlate with biomarkers (under given dose)?<br>;Timepoint(s) of evaluation of this end point: 2 weeks after dosing;Main Objective: Do degarelix reduce the risk of committing sexual child molestation for patients with pedophilic disorder?<br><br><br>;Primary end point(s): Primary endpoint consists of a composite measure of 0-15 points, based on estimates for different risk factors for sexual abuse. 0-5 = low risk. 6-10 = medium risk. 11-15 = high risk. Primary endpoint mirrors therefore risk the abuse of children, it is not the actual number of sexual abuse of children.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Adveres events<br>biomarkers<br>;Timepoint(s) of evaluation of this end point: 0-100 days after treatment