Novel Testosterone-Suppressing Drug Promising For Pedophilic Disorder

The gonadotropin-releasing hormone (GnRH) antagonist degarelix reduced the risk of pedophilic men committing child abuse in a phase 2 study.

"I hope this will be perceived as a candle in the dark—that there's hope," Dr. Christoffer Rahm of the Karolinska Institute in Stockholm told Reuters Health by email. "The men overall appreciated the effects of the medicine subjectively, not least the effects on sexuality. It's a win/win, and an important step towards evidence-based treatment for pedophilic disorder."

"The need for new initiatives to counteract the sexual exploitation of children online has increased even more in the past few months as a result of the the corona pandemic and the lockdowns and quarantine," he added. "We noticed a marked increase in activity in dark web chat forums, dedicated to the spread of child sexual abuse material (CSAM, previously called child pornography). They are much more crowded and the people in the chats more hostile."

Dr. Rahm and colleagues randomized 52 men (mean age, 36) to two subcutaneous injections of 120 mg degarelix or placebo. The primary end point was the mean change between baseline and 2 weeks in the composite risk score of five domains of child sexual abuse; each domain could be rated from 0 to 3 points. Secondary endpoints included quality of life, self-reported effects and adverse events.

As reported in JAMA Psychiatry, at 2 weeks, the composite risk score decreased from 7.4 to 4.4 in the degarelix group and from 7.8 to 6.6 for placebo group.

Statistically significant differences also were observed in composite risk scores for degarelix vs placebo at 10 weeks (−2.2), and in the domains of pedophilic disorder (2 weeks: −0.7; 10 weeks: −1.1) and sexual preoccupation (2 weeks: −0.7; 10 weeks: −0.8).

By contrast, no difference was seen for self-rated risk (2 weeks: −0.4; 10 weeks: −0.5); low empathy (2 weeks: 0.2; 10 weeks: 0.2); impaired self-regulation (2 weeks: −0.0; 10 weeks: 0.1; or quality of life (EuroQol 5 Dimensions questionnaire index score at 2 weeks: 0.06; 10 weeks: 0.04; EuroQol visual analog scale, 2 weeks: 0.6, and 10 weeks: 4.2).

In the degarelix group, two hospitalizations occurred from increased suicidal ideation. There were also more injection site reactions (88% vs. 4%) and liver enzyme elevations (44% vs. 8%).

Overall, 77% of degarelix participants experienced positive effects on sexuality (e.g., improved attitude or behavior) and 89% reported adverse effects on the body.

The authors note, "The rapid onset of degarelix appears to have a crucial advantage compared with earlier medications for paraphilic disorders, which had a 1 to 3 months' lag in exerting their effects on sexuality."

Dr. Rahm said his team currently is conducting a trial of dark web forum participants to evaluate the effectiveness of a new internet-based cognitive behavioral therapy, aimed at stopping or reducing their use of CSAM.

"For methodological reasons, we need to evaluate one treatment at a time, to see who is helped by what and why," he noted. "But in clinical practice, I recommend a combination of medicine and psychosocial support, depending on the individual's needs and risk profile. Some individuals also need psychotherapy."

"More female offenders need to be included in studies," he acknowledged, and women are included in his dark web trial. "A trend in recent years is that there are more and more female perpetrators in the CSAM online, but we know very little about them as a group."

Dr. Peer Briken of University Medical Centre in Hamburg, author of a related editorial, commented in an email to Reuters Health, "The Swedish group showed that a randomized controlled trial in outpatients with pedophilic disorder is feasible. This is a very important step forward in legal and ethical discussions in the field."

"No study group managed to do that before," he noted. "It should inspire other groups also to test other interventions like psychotherapy... in the future."

Future studies will have to investigate long term-effects (of degarelix), side effects such as depression and suicidality, as well as the option to switch to other medications, he concluded.

—Marilynn Larkin

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