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Study on the Effects of Escitalopram, Paroxetine, and Naltrexone for Patients with Compulsive Sexual Behavior Disorder

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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 the effects of different treatments for Compulsive Sexual Behavior Disorder (CSBD). The treatments being tested include medications such as escitalopram, paroxetine, naltrexone, and a combination of escitalopram and naltrexone. There is also a group receiving a placebo. The purpose of the study is to compare how these treatments affect the symptoms of CSBD.

Participants in the study will take one of the medications or a placebo for a period of time. The study will monitor changes in the severity of their symptoms, which include behaviors like viewing pornography, masturbation, or using paid sexual services. The study aims to see if these treatments can help reduce the frequency and intensity of these behaviors.

The trial will involve regular check-ins where participants will report on their symptoms and any changes they experience. This information will help researchers understand which treatment is most effective in managing CSBD. The study is expected to continue for several years to gather comprehensive data on the effectiveness of these treatments.

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 verifying age, gender, and a documented diagnosis of compulsive sexual behaviour disorder (CSBD) according to ICD-11 guidelines.

    Participants must provide informed consent and agree to the processing of personal data.

  2. Step 2

    Baseline evaluation

    A baseline evaluation is performed to measure the severity of CSBD symptoms. This involves completing scales such as the CSBD-19 and BPS.

    Participants are required to maintain a diary to record the frequency of compulsive sexual behavior.

  3. Step 3

    Medication administration

    Participants are randomly assigned to receive one of the following treatments: escitalopram (10 mg), paroxetine (20 mg), naltrexone (50 mg), a combination of escitalopram and naltrexone, or a placebo.

    All medications are administered orally in the form of film-coated tablets.

  4. Step 4

    Treatment phase

    The treatment phase involves regular administration of the assigned medication. Participants are monitored for changes in CSBD symptoms and any side effects.

    Regular follow-up assessments are conducted to evaluate the effectiveness of the treatment using scales such as the CSBD-19, BPS, and others.

  5. Step 5

    Final evaluation

    At the end of the treatment phase, a final evaluation is conducted to assess the overall impact of the medication on CSBD symptoms.

    Participants complete the same scales used in the baseline evaluation to measure changes in symptom severity.

Who can join the trial?

6 criteria

  • Must be a male between the ages of 18-60 years.
  • Must have signed an informed consent form, which means agreeing to participate in the study and allowing the use of personal data.
  • Must be willing to take part in all the procedures that are part of the study.
  • Must feel a loss of control over sexual behavior, such as watching pornography, masturbation, or using paid sexual services.
  • Must be seeking specialized help or therapy, including medication, for the symptoms or their consequences.
  • Must have a documented diagnosis of Compulsive Sexual Behaviour Disorder (CSBD) according to the guidelines from the World Health Organization (WHO).

Who cannot join the trial?

3 criteria

  • Individuals who are not male cannot participate in the study.
  • Individuals who are under 18 years old or over 65 years old cannot participate in the study.
  • Individuals who are part of a vulnerable population, which means they might need special protection or care, cannot participate in the study.
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Investigated drugs

  • Escitalopram

    is a medication commonly used to treat depression and anxiety. In this trial, it is being tested to see if it can help reduce the symptoms of compulsive sexual behavior disorder (CSBD).

  • Paroxetine

    is another medication often used to treat depression, anxiety disorders, and obsessive-compulsive disorder. The trial is investigating its effectiveness in reducing the symptoms of CSBD.

  • Naltrexone

    is a medication typically used to treat alcohol and opioid dependence. In this study, it is being evaluated for its potential to help manage symptoms of CSBD.

  • Escitalopram plus Naltrexone

    is a combination treatment being tested in the trial. The study aims to determine if using both medications together is more effective in reducing CSBD symptoms than using them separately.

What is already known about the treatment

  • Escitalopram

    This medication is typically administered orally in tablet form. It is currently well-established in medical literature as a treatment for various mental health conditions. Escitalopram is primarily used to treat depression and anxiety disorders. It works by increasing the levels of serotonin, a neurotransmitter, in the brain, which helps improve mood and reduce anxiety. It belongs to the pharmacological class of selective serotonin reuptake inhibitors (SSRIs).

  • Paroxetine

    Paroxetine is usually taken orally as a tablet. It is widely recognized in the medical community for its effectiveness in treating mental health issues. The main therapeutic uses of paroxetine include treating depression, anxiety disorders, and obsessive-compulsive disorder. It functions by enhancing serotonin activity in the brain, which helps elevate mood and reduce anxiety. Paroxetine is classified as a selective serotonin reuptake inhibitor (SSRI).

  • Naltrexone

    Naltrexone is administered orally in tablet form or as an injectable. It is well-documented in medical literature for its role in treating addiction. The primary use of naltrexone is to help manage alcohol and opioid dependence. It works by blocking opioid receptors in the brain, which reduces the pleasurable effects of alcohol and opioids. Naltrexone is classified as an opioid antagonist.

Investigated diseases

Compulsive Sexual Behavior Disorder – This disorder is characterized by an overwhelming urge to engage in sexual activities, often leading to distress or impairment in daily functioning. Individuals with this condition may find it difficult to control their sexual thoughts, urges, or behaviors, which can become a central focus of their lives. The disorder often involves repetitive sexual activities that are carried out despite negative consequences, such as relationship issues or legal problems. People with this disorder may experience a cycle of intense sexual urges followed by temporary relief after acting on these urges, only to feel guilt or shame afterward. The behavior is typically persistent and can interfere with personal, social, or occupational responsibilities.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514490-22-00Protocol codeCSBD-TREstimated enrolment410 patientsSponsorCentrum Medycznego Ksztalcenia Podyplomowego

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