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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as pedophilic disorder. The trial aims to explore the effectiveness of different treatments for individuals who seek help for problematic sexual behaviors. The study will compare the use of a medication called fluoxetine, which is commonly used to treat mood disorders, with an internet-based therapy known as iCBT (internet-based Cognitive Behavioral Therapy). Both treatments will be evaluated against a standalone psychoeducational program to see which is more effective in reducing these behaviors.

Participants in the study will be randomly assigned to one of the treatment groups. The study will last for a period of 14 weeks, during which participants will receive either the medication, the internet-based therapy, or the psychoeducational program. The medication, fluoxetine, will be administered in capsule form and taken orally. The internet-based therapy will involve online sessions designed to help manage and change problematic thoughts and behaviors.

The purpose of this study is to determine which treatment approach is most beneficial for individuals with pedophilic disorder who are actively seeking help. By comparing these different methods, the study aims to provide valuable insights into effective treatment options for reducing problematic sexual behaviors in this population. Participants will be monitored throughout the study to assess the impact of the treatments on their behaviors and overall well-being.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing the signed informed consent form and verifying that the participant meets the inclusion criteria, such as age, gender, language proficiency, and access to necessary technology.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of the treatment groups. The groups include a standalone psychoeducational program, an add-on therapy with fluoxetine, or an internet-based cognitive behavioral therapy (iCBT).

  3. Step 3

    Treatment phase

    Participants in the fluoxetine group receive the medication orally. The dosage and frequency are determined by the study protocol and are monitored throughout the trial.

    Participants in the iCBT group engage in structured online therapy sessions. These sessions are designed to address problematic behaviors and are conducted over the internet.

    The standalone psychoeducational program involves educational sessions aimed at reducing problematic sexual behaviors.

  4. Step 4

    Monitoring and follow-up

    Throughout the 14-week trial period, participants attend regular visits for monitoring. These visits include providing blood and urine samples to ensure safety and track progress.

    Participants' progress is evaluated to determine the effectiveness of the assigned treatment in reducing problematic behaviors.

  5. Step 5

    Completion of trial

    At the end of the 14-week period, participants complete the trial. Final assessments are conducted to evaluate the outcomes of the treatment.

Who can join the trial?

7 criteria

  • Must have signed an informed consent form, which means you agree to participate in the study after understanding what it involves.
  • Must be between the ages of 18 and 65 years old.
  • Must be male.
  • Must be able to read and communicate in Swedish.
  • Must have access to a computer or similar device and the internet.
  • Must meet the criteria for **pedophilic disorder** or **hebephilia** according to the DSM-5, which is a manual used by healthcare professionals to diagnose mental disorders.
  • Must agree to participate in all trial visits, which includes providing blood and urine samples.

Who cannot join the trial?

3 criteria

  • Individuals who do not identify as male cannot participate in the study.
  • Individuals who are not seeking help for their sexual interest in children cannot participate in the study.
  • Individuals who are part of a vulnerable population, meaning they might need special protection or care, cannot participate in the study.
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Investigated drugs

  • Fluoxetine

    is a medication commonly used to treat depression, anxiety, and certain other mood disorders. In this trial, it is being used to see if it can help reduce problematic sexual behaviors in men who are seeking help for their sexual interest in children. It is being tested as an add-on therapy to see if it is more effective than just a psychoeducational program alone.

  • iCBT (Internet-based Cognitive Behavioral Therapy)

    is a form of therapy that uses online tools to help individuals change their thinking patterns and behaviors. In this trial, iCBT is being evaluated to determine if it can effectively reduce problematic sexual behaviors in men with sexual interest in children when used alongside a psychoeducational program.

What is already known about the treatment

Fluoxetine – Fluoxetine is typically administered orally in the form of capsules or tablets. It is a well-established medication in the field of psychiatry and is widely documented in medical literature. The main therapeutic indication for fluoxetine is the treatment of depression, anxiety disorders, and certain other mental health conditions. At the molecular level, fluoxetine works by inhibiting the reuptake of serotonin in the brain, which helps to improve mood and reduce anxiety. It is classified as a selective serotonin reuptake inhibitor (SSRI).

Investigated diseases

Pedophilic Disorder – Pedophilic disorder is characterized by recurrent, intense sexually arousing fantasies, urges, or behaviors involving sexual activity with a prepubescent child or children. Individuals with this disorder may experience distress or interpersonal difficulty due to these urges or behaviors. The disorder is typically identified in adulthood, although the onset of these feelings may occur during adolescence. It is important to note that having these urges does not necessarily mean an individual will act on them. The disorder can lead to significant personal and social challenges, affecting relationships and daily functioning. Understanding and managing these urges is crucial for those affected by the disorder.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513388-16-00Estimated enrolment111 patientsSponsorKarolinska University Hospital

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