Degarelix may reduce risk for committing child sexual abuse among men with pedophilic disorder
Click Here to Manage Email Alerts
Degarelix appeared to reduce the risk score for committing child sexual abuse among men with pedophilic disorder, according to results of a randomized phase 2 trial published in JAMA Psychiatry.
“Studies have found that not all men with pedophilic disorder commit a sexual offense, but those who do generally report struggling with their sexual urges for 10 years before committing a sexual crime,” Valdemar Landgren, MD, of the Institute of Neuroscience and Physiology at Gothenburg University in Sweden, and colleagues wrote. “Consequently, an opportunity for prevention exists in treating high-risk individuals without prior convictions. Effective treatment could prevent child sexual abuse and reduce psychosocial stress for the individual with pedophilic disorder.”
Currently recommended interventions for pedophilic disorder — defined as recurrent sexual attraction to prepubescent children associated with distress or negative consequences — include antidepressants and psychotherapy, as well as testosterone-suppressing medications for high-risk individuals. Landgren and colleagues noted that gonadotropin-releasing hormone agonists may effectively reduce paraphilic symptoms because they lower testosterone through receptor desensitization; however, their use is limited to supervised correctional settings.
Because evidence-based treatments from randomized clinical trials for pedophilic disorder are lacking, the researchers sought to determine whether a gonadotropin-releasing antagonist reduced dynamic child sexual abuse risk factors. The academically initiated, double-blind, placebo-controlled trial, conducted at the ANOVA center in Stockholm from March 2016 to April 2019, recruited men who contacted the national telephone helpline for unwanted sexuality. They included men aged 18 to 66 years with a pedophilic disorder diagnosis who sought help and had no contraindications to the intervention.
Interventions included random assignment to either two subcutaneous injections of 120 mg of degarelix acetate, a gonadotropin-releasing hormone antagonist used in the treatment of prostate cancer, or equal volume of placebo. Mean change between baseline and 2 weeks in the composite risk score of five domains of child sexual abuse ranging from 0 to 15 points served as the primary endpoint, which the researchers assessed by intent-to-treat analysis. Efficacy at 2 weeks and 10 weeks as measured by the composite score, each risk domain, quality of life, self-reported effects and adverse events served as secondary endpoints.
The researchers randomly assigned 52 men (mean age, 36 years) to degarelix (n = 25, with one withdrawal) or placebo (n = 26). They reported the composite risk decreased from 7.4 to 4.4 for those in the degarelix group and 7.8 to 6.6 for the placebo group at 2 weeks for a mean between-group difference of –1.8 (95% CI, –3.2 to –0.5). At 10 weeks, they observed a decrease of 2.2 (95% CI, 3.6 to 0.7) in the composite score, as well as a decrease of 1.1 (95% CI, 1.8 to 0.4) in the domain of pedophilic disorder and a decrease of 0.8 (95% CI, 1.3 to 0.3) in the domain of sexual preoccupation in the degarelix group vs. the placebo group.
The researchers observed no difference in the domains of self-rated risk, low empathy and impaired self-regulation, or quality of life. They noted two hospitalizations occurred from increased suicidal ideation, and participants who received degarelix reported more injection site reactions and hepatobiliary enzyme level elevations. Of the 26 participants who received degarelix, 20 (77%) exhibited positive effects, such as improved attitude or behavior, on sexuality and 23 (89%) reported adverse effects on the body.
“This is an important step forward," study co-author Christoffer Rahm, MD, of Stockholm Health Care Services, told Healio Psychiatry. "The medicine turned out to be effective in reducing the risk, not least in the small subgroup of high-risk individuals, and was also well tolerated by most patients. As a clinician, it is very valuable to have access to treatment interventions you know you can trust, that you can honestly recommend to a patient, and for which you can feel quite certain what the outcome will be. Knowing that a doctor is basing his/her work on evidence-based grounds feels reassuring for the patient and everyone else involved, such as families and authorities, and makes more patients seek help.”
In a related editorial, Peer Briken, MD, of the Institute for Sex Research, Sexual Medicine and Forensic Psychiatry at University Medical Centre in Germany, highlighted the importance of this study for the field of pharmacotherapy of pedophilic disorders.
“It has been stated that it might not be possible to carry out [randomized clinical trials] for ethical reasons because it might be unethical to withhold therapy from high-risk participants and thus risk sexual assaults on children in a control group,” Briken wrote. “With the [current study], the situation has changed, which marks a milestone in clinical sexual science and the field of forensic psychiatry. Landgren [and colleagues] have solved the problem with an elegant design and at the same time introduced a new drug into the therapeutic field. The innovative potential of this study should therefore not be underestimated.” – by Joe Gramigna
Disclosures: The study authors and Briken report no relevant financial disclosures.