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Pharmacological treatment of compulsive sexual behaviour disorder
EU CTIS ID: 2024-514490-22-00
What this study is testing
Comparison of the effects of treatment with escitalopram, paroxetine, naltrexone, and combined treatment (escitalopram plus naltrexone) or placebo on reducing the severity of symptoms of CSBD.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male gender and age 18-60 years
- Signed informed consent form for participation in the study and consent to the processing of personal data
- Declared willingness to participate in the procedures included in the study protocol
- Subjective sense of loss of control over one's sexual behavior (e.g., viewing pornography, masturbation, or use of paid sexual services, etc.),
- Seeking specialized help/therapy including pharmacotherapy for perceived symptoms or consequences of the symptoms,
- Documented diagnosis of CSBD according to ICD-11 diagnostic guidelines (WHO, 2022)
You likely can't join if
- Co-occurrence of mania or bipolar affective disorder, moderate or severe depression episode, psychotic disorders, obsessive-compulsive disorder or cognitive impairment (dementia, mental retardation) according ro ICD-11 diagnostic guidelines (WHO, 2022)
- Any laboratory result deviating from normal values (laboratory norm) will be analyzed on an individualized basis in conjunction with the participant's clinical condition and medical history. Laboratory deviations that are the basis for the decision not to start or withhold pharmacotherapy, and thus discontinue the patient's participation in the study. 1)aspartate aminotrasferase (AST), alanine aminotransferase (ALT) - activity exceeding 3 times the upper limit of normal 2)hemoglobin < 10 g/dL, 3)leukocytes <3000/µL, 4)platelets <100,000/µL, 3)fasting glucose > 120 mg%. 4)creatinine - increase in concentration exceeding 1.5 times the upper limit of normal 5)eGFR ≤ 50 ml/min/1.73m2 6)sodium - hyponatremia < 126 mmol/L or hypernatremia > 150 mmol/L, 7)potassium - hypokalemia ≤ 3 mmol/L, hyperkalemia ≥ 5.9 mmol/L.
- Current use of antidepressant, anti-anxiety, antipsychotic or mood-stabilizing medications
- Current use of psychotherapy or other psychological support
- Clinically significant neurological disorders reported in the medical history
- Current psychoactive substance dependence, compulsive gambling
See the full eligibility criteria
Who can join
- Male gender and age 18-60 years
- Signed informed consent form for participation in the study and consent to the processing of personal data
- Declared willingness to participate in the procedures included in the study protocol
- Subjective sense of loss of control over one's sexual behavior (e.g., viewing pornography, masturbation, or use of paid sexual services, etc.),
- Seeking specialized help/therapy including pharmacotherapy for perceived symptoms or consequences of the symptoms,
- Documented diagnosis of CSBD according to ICD-11 diagnostic guidelines (WHO, 2022)
What rules you out
- Co-occurrence of mania or bipolar affective disorder, moderate or severe depression episode, psychotic disorders, obsessive-compulsive disorder or cognitive impairment (dementia, mental retardation) according ro ICD-11 diagnostic guidelines (WHO, 2022)
- Any laboratory result deviating from normal values (laboratory norm) will be analyzed on an individualized basis in conjunction with the participant's clinical condition and medical history. Laboratory deviations that are the basis for the decision not to start or withhold pharmacotherapy, and thus discontinue the patient's participation in the study. 1)aspartate aminotrasferase (AST), alanine aminotransferase (ALT) - activity exceeding 3 times the upper limit of normal 2)hemoglobin < 10 g/dL, 3)leukocytes <3000/µL, 4)platelets <100,000/µL, 3)fasting glucose > 120 mg%. 4)creatinine - increase in concentration exceeding 1.5 times the upper limit of normal 5)eGFR ≤ 50 ml/min/1.73m2 6)sodium - hyponatremia < 126 mmol/L or hypernatremia > 150 mmol/L, 7)potassium - hypokalemia ≤ 3 mmol/L, hyperkalemia ≥ 5.9 mmol/L.
- Current use of antidepressant, anti-anxiety, antipsychotic or mood-stabilizing medications
- Current use of psychotherapy or other psychological support
- Clinically significant neurological disorders reported in the medical history
- Current psychoactive substance dependence, compulsive gambling
- Positive drug test result
- Any medical contraindication to the use of escitalopram, paroxetine or naltrexone hydrochloride (according to summary of product characteristics)
- Use of other drugs that have clinically significant or pharmacokinetic interactions with the investigational medicinal products
- Other conditions that, in the opinion of the investigator, constitute significant contraindications to participation in the clinical trial, e.g. inability to participate in all study procedures including cognitive impairment to the extent that it is impossible to understand the study procedures and participate in the procedures
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.