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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Szpital Bielanski Im.Ks.Jerzego Popieluszki samodzielny publiczny zakład opieki zdrowotnej	Warsaw	Poland

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Poland	Not yet recruiting	01.10.2024

Trial locations

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.

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 ID:

2024-514490-22-00

Protocol code:

CSBD-TR

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?