NALTREXONE HYDROCHLORIDE for Compulsive sexual behaviour disorder

Inclusion criteria

• {"criterion_text":"- Male gender and age 18-60 years"}
• {"criterion_text":"- Signed informed consent form for participation in the study and consent to the processing of personal data"}
• {"criterion_text":"- Declared willingness to participate in the procedures included in the study protocol"}
• {"criterion_text":"- Subjective sense of loss of control over one's sexual behavior (e.g., viewing pornography, masturbation, or use of paid sexual services, etc.),"}
• {"criterion_text":"- Seeking specialized help/therapy including pharmacotherapy for perceived symptoms or consequences of the symptoms,"}
• {"criterion_text":"- Documented diagnosis of CSBD according to ICD-11 diagnostic guidelines (WHO, 2022)"}

Exclusion criteria

• {"criterion_text":"- 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)"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Current use of antidepressant, anti-anxiety, antipsychotic or mood-stabilizing medications"}
• {"criterion_text":"- Current use of psychotherapy or other psychological support"}
• {"criterion_text":"- Clinically significant neurological disorders reported in the medical history"}
• {"criterion_text":"- Current psychoactive substance dependence, compulsive gambling"}
• {"criterion_text":"- Positive drug test result"}
• {"criterion_text":"- Any medical contraindication to the use of escitalopram, paroxetine or naltrexone hydrochloride (according to summary of product characteristics)"}
• {"criterion_text":"- Use of other drugs that have clinically significant or pharmacokinetic interactions with the investigational medicinal products"}
• {"criterion_text":"- 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"}

Primary endpoints

• {"endpoint_text":"- Scores obtained on the CSBD-19 scale","definition_or_measurement_approach":"Scores obtained on the CSBD-19 scale"}
• {"endpoint_text":"- Scores obtained on the BPS scale","definition_or_measurement_approach":"Scores obtained on the BPS scale"}
• {"endpoint_text":"- Frequency of compulsive sexual behavior measured by patient diary data.","definition_or_measurement_approach":"Measured by patient diary data"}
• {"endpoint_text":"- The severity of the perceived “desire” for compulsive sexual behavior","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Scores obtained on the CSBD-DI scale.","definition_or_measurement_approach":"Scores obtained on the CSBD-DI scale"}
• {"endpoint_text":"- Scores obtained on the HADS scale.","definition_or_measurement_approach":"Scores obtained on the HADS scale"}
• {"endpoint_text":"- Scores obtained on the DERS-SF scale.","definition_or_measurement_approach":"Scores obtained on the DERS-SF scale"}
• {"endpoint_text":"- Scores obtained on the IIEF-15 scale.","definition_or_measurement_approach":"Scores obtained on the IIEF-15 scale"}
• {"endpoint_text":"- Scores obtained on the BIS scale.","definition_or_measurement_approach":"Scores obtained on the BIS scale"}
• {"endpoint_text":"- Responsiveness to erotic stimulus cues measured by behavioral performance (reaction time and correctness of performance) in the Incentive Delay Task","definition_or_measurement_approach":"Measured by behavioral performance: reaction time and correctness in the Incentive Delay Task"}
• {"endpoint_text":"- Reactivity to cues of erotic stimuli measured by neuronal indices (amplitude of evoked potentials in EEG) in the Incentive Delay Task","definition_or_measurement_approach":"Measured by neuronal indices: amplitude of evoked potentials in EEG during the Incentive Delay Task"}
• {"endpoint_text":"- Scores obtained on the CSBD-19 scale","definition_or_measurement_approach":"Scores obtained on the CSBD-19 scale"}
• {"endpoint_text":"- Scores obtained on the BPS scale","definition_or_measurement_approach":"Scores obtained on the BPS scale"}
• {"endpoint_text":"- Frequency of compulsive sexual behavior measured by patient diary data.","definition_or_measurement_approach":"Measured by patient diary data"}
• {"endpoint_text":"- The severity of the perceived “desire” for compulsive sexual behavior.","definition_or_measurement_approach":""}

Poland

Earliest CTIS Part Ii Submission Date

02-09-2024

Latest Decision Or Authorization Date

30-09-2024

Processing Time Days

28

Number Of Sites

1

Number Of Participants

410

Primary sponsor

Full Name

Centrum Medyczne Ksztalcenia Podyplomowego

Organisation Type

Educational Institution

Country Of Registered Address

Poland

Third parties

• {"country":"","full_name":"Agencja Badań Medycznych (ABM)","duties_or_roles":"Monetary support","organisation_type":""}