Paedophilia Trials in Disease

Study on Fluoxetine and E-therapy for Men Seeking Help with Pedophilic Disorder

This clinical trial is focused on finding effective treatments for men who are actively seeking help for problematic sexual behaviors related to pedophilic disorder. The study takes place over 14 weeks and compares three different approaches: a medication called fluoxetine, an internet-based therapy program, and a standalone educational program.

Main focus and goals: The trial aims to determine which treatment method is most effective in reducing problematic sexual behaviors. Participants are randomly assigned to receive either fluoxetine (a medication commonly used for depression and anxiety), internet-based Cognitive Behavioral Therapy (iCBT), or a psychoeducational program. Researchers will monitor participants throughout the study to evaluate which approach provides the most benefit.

Who can participate: The trial is open to men between 18 and 65 years of age who meet the diagnostic criteria for pedophilic disorder or hebephilia according to professional standards. Participants must be able to read and communicate in Swedish, have access to a computer and internet, and be willing to attend all trial visits, including providing blood and urine samples for monitoring purposes. All participants must sign an informed consent form, demonstrating they understand what the study involves.

Who cannot participate: Individuals who do not identify as male are excluded from the study. Additionally, those who are not actively seeking help for their sexual interest in children cannot participate. People who are considered part of a vulnerable population requiring special protection are also excluded.

Investigational treatments: The trial examines two main interventions alongside a standard psychoeducational program. Fluoxetine is a medication that belongs to a class of drugs called selective serotonin reuptake inhibitors (SSRIs). It is typically administered orally in capsule form and works by increasing serotonin levels in the brain, which can help improve mood and reduce anxiety. In this study, researchers are investigating whether it can also help reduce problematic sexual behaviors. Internet-based Cognitive Behavioral Therapy (iCBT) is an online therapeutic approach that helps individuals change problematic thinking patterns and behaviors through structured online sessions.

What happens during the trial: After an initial assessment to confirm eligibility, participants are randomly assigned to one of the three treatment groups. Those receiving fluoxetine take the medication orally according to the study protocol. Those in the iCBT group participate in structured online therapy sessions. The third group receives a standalone psychoeducational program designed to reduce problematic behaviors through education. Throughout the 14-week period, participants attend regular monitoring visits to track their progress and ensure their safety. At the end of the trial, final assessments are conducted to evaluate the outcomes of each treatment approach.