Efficacy of Fluoxetine and Internet-Based Cognitive Behavioral Therapy in Reducing Problematic Sexual Behaviors in Men with Pedophilic Disorder

The primary objective of the study is to evaluate the efficacy of **fluoxetine** or internet-based cognitive behavioral therapy (**iCBT**) as add-on therapies compared to a standalone psychoeducational program in reducing problematic sexual behaviors in help-seeking men with **pedophilic disorder**. This is clinically relevant as it aims to identify more effective treatment strategies for managing such behaviors, potentially improving patient outcomes and reducing the risk of harm.

Secondary objectives include:

• Investigating clinical and sociodemographic parameters associated with sexual interest in children (SIC).
• Exploring biological markers linked to SIC.
• Evaluating treatment interventions and comparing the effectiveness of fluoxetine or iCBT in reducing psychiatric comorbidity symptoms, perceived loneliness, and cognitive distortions.
• Assessing differences in drop-out rates, adherence, and adverse effects between treatment groups.
• Comparing treatment satisfaction and investigating predictors of treatment response, drop-out rates, and adherence.

The clinical trial involves a study population of **male** participants aged 18 to 65 years, all of whom have been diagnosed with **pedophilic disorder** or hebephilia according to DSM-5 criteria. The total number of participants has not been disclosed by the sponsor. Participants were selected based on their ability to read and communicate in Swedish, access to a computing device and the internet, and their willingness to participate in all trial visits, including providing blood and urine samples. The trial does not include female subjects and does not focus on a vulnerable population. Participants are required to have signed an informed consent form and are expected to engage in a lifestyle that allows for the completion of the trial's requirements. The study aims to assess the effectiveness of add-on therapy with fluoxetine or iCBT compared to a standalone psychoeducational program in reducing problematic sexual behaviors in help-seeking men with sexual interest in children.

The clinical trial is designed to evaluate the efficacy of **fluoxetine** as an add-on therapy compared to a standalone psychoeducational program in reducing problematic sexual behaviors in men with **pedophilic disorder**. This trial is a randomized, double-blind, controlled study, ensuring that neither the participants nor the researchers know which treatment the participants are receiving, thus minimizing bias. The trial is categorized as a low-intervention study due to the well-known and well-tested nature of the medication involved, with a low risk to participants. The trial is set to run from March 2022 to March 2028, with a primary endpoint at 14 weeks post-randomization.

Participants will undergo a series of study visits, beginning with an inclusion visit where eligibility is confirmed through criteria such as age, gender, language proficiency, and diagnosis according to DSM-5 criteria. This visit will also involve obtaining informed consent and baseline assessments. Follow-up visits will occur at regular intervals to monitor the participants' progress, adherence to the treatment regimen, and any adverse effects. The end-of-study visit will involve final assessments to evaluate the primary and any secondary endpoints. The expected length of participant involvement is approximately 14 weeks, with conditions for early termination including withdrawal of consent, non-compliance with study procedures, or adverse events that warrant discontinuation.

Participants are required to agree to all trial visits, including providing blood and urine samples, and must have access to a computing device and the internet. The trial's primary objective is to determine whether **fluoxetine** or internet-based cognitive behavioral therapy (iCBT) is more effective than a standalone psychoeducational program. The study will adhere to rigorous scientific standards to ensure the reliability and validity of the results, contributing valuable insights into the treatment of **pedophilic disorder**.

The clinical trial involves the administration of **FLUOXETINE**, an experimental medication, to evaluate its efficacy in reducing problematic sexual behaviors in men with sexual interest in children. **FLUOXETINE** is provided in the form of **capsules** and is administered **orally**. The maximum daily dose is **40 mg**, with a total maximum dose of **3360 mg** over a treatment period of **14 days**. The active substance, **fluoxetine**, is of chemical origin. Participants are required to adhere to the dosing schedule, and compliance will be monitored throughout the trial.

In addition to the experimental treatment, the study includes a comparator treatment involving a standalone psychoeducational program. This program serves as the control condition against which the efficacy of **FLUOXETINE** and an internet-based cognitive behavioral therapy (iCBT) will be assessed. The trial aims to determine whether the add-on therapy with **FLUOXETINE** or iCBT is more effective than the psychoeducational program alone. Participants' adherence to the psychoeducational program will also be monitored to ensure compliance and accurate assessment of treatment outcomes.

The efficacy of the clinical trial titled "PARACHUTES: Pedophilia At Risk – Acute Treatment – E-therapy vs SSRI" will be assessed by evaluating the reduction of problematic sexual behaviors in help-seeking men with sexual interest in children. The primary objective is to determine whether add-on therapy with **fluoxetine** or internet-based cognitive behavioral therapy (iCBT) is more effective than a standalone psychoeducational program. The primary endpoint for assessing efficacy is set at 14 weeks from randomization. The trial will involve the administration of **fluoxetine** in capsule form, with a maximum daily dose of 40 mg and a total maximum dose of 3360 mg over a 14-week period. Efficacy assessments will be conducted using validated scales and patient-reported outcomes to measure changes in sexual behavior. The trial is categorized as a low-intervention study, given the well-known and well-tested nature of the medication, posing low risk to participants. The trial is in Phase 4, indicating it is focused on post-marketing surveillance to gather additional information on the drug's effectiveness and safety in a larger population. The study is designed to ensure participants meet specific inclusion criteria, including being male, aged 18-65, and meeting the criteria for pedophilic disorder or hebephilia as per DSM-5.