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Pharmacological treatment of compulsive sexual behaviour disorder
EU CTIS ID: 2024-514490-22-01
What this study is testing
Comparison of the effects of treatment with escitalopram, 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,
- Fulfilling the criteria for the diagnosis of CSBD according to the ICD-11 diagnostic guidelines (WHO, 2022): 1) A persistent pattern of inability to control intense, repetitive sexual impulses or arousals resulting in repetitive sexual behavior manifested by one or more of the following: (a) repeated sexual activities become the focal point of the person's life to the point of neglecting health and personal needs or other interests, activities and responsibilities (b) the person has made repeated unsuccessful attempts to control or significantly reduce repetitive sexual behavior (c) the person continues to engage in repeated sexual behavior despite its negative consequences (e.g., relationship conflict caused by the sexual behavior, financial or legal consequences, negative health effects) or derives little or no satisfaction from it (d) the person continues to engage in repeated sexual behavior even despite deriving little or no satisfaction from it. 2) The pattern of inability to control intense sexual impulses or arousals and the resulting repetitive sexual behavior manifests itself over an extended period of time (6 months or longer) 3) The pattern of inability to control intense sexual impulses or arousals and the resulting repetitive sexual behavior is not caused by another mental disorder (e.g., an episode of mania) or other medical condition, or the effects of a substance or drug. 4) The pattern of inability to control intense sexual impulses or urges and the resulting repetitive sexual behavior causes clinically significant suffering or significant impairment of personal, family, social, educational, occupational or other important spheres of functioning. Suffering that is related to moral judgments and disapproval of sexual impulses, motives or behavior is not sufficient to meet this condition
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-10 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
- Clinically significant neurological disorders reported in the medical history
- Current psychoactive substance dependence, compulsive gambling
- Positive drug test result
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,
- Fulfilling the criteria for the diagnosis of CSBD according to the ICD-11 diagnostic guidelines (WHO, 2022): 1) A persistent pattern of inability to control intense, repetitive sexual impulses or arousals resulting in repetitive sexual behavior manifested by one or more of the following: (a) repeated sexual activities become the focal point of the person's life to the point of neglecting health and personal needs or other interests, activities and responsibilities (b) the person has made repeated unsuccessful attempts to control or significantly reduce repetitive sexual behavior (c) the person continues to engage in repeated sexual behavior despite its negative consequences (e.g., relationship conflict caused by the sexual behavior, financial or legal consequences, negative health effects) or derives little or no satisfaction from it (d) the person continues to engage in repeated sexual behavior even despite deriving little or no satisfaction from it. 2) The pattern of inability to control intense sexual impulses or arousals and the resulting repetitive sexual behavior manifests itself over an extended period of time (6 months or longer) 3) The pattern of inability to control intense sexual impulses or arousals and the resulting repetitive sexual behavior is not caused by another mental disorder (e.g., an episode of mania) or other medical condition, or the effects of a substance or drug. 4) The pattern of inability to control intense sexual impulses or urges and the resulting repetitive sexual behavior causes clinically significant suffering or significant impairment of personal, family, social, educational, occupational or other important spheres of functioning. Suffering that is related to moral judgments and disapproval of sexual impulses, motives or behavior is not sufficient to meet this condition
- Achieving a score of 50 points or higher on the CSBD-19 questionnaire
- Declared adherence to rules related to the use of contraception and exposure of a partner who could potentially become pregnant to the drug (means the use of a male condom and a second acceptable method of contraception of high effectiveness during the period of taking the test substance and for a period of 100 days after the end of taking the test substance if engaging in sexual relations with a partner who could potentially become pregnant and 7 days if the partner is pregnant)
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-10 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
- 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 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.