Escitalopram oxalate 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":"- 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"}
• {"criterion_text":"- Achieving a score of 50 points or higher on the CSBD-19 questionnaire"}
• {"criterion_text":"- 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)"}

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-10 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 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":"Measured using the CSBD-19 symptom questionnaire; endpoint is the score obtained on the CSBD-19 scale."}
• {"endpoint_text":"- Scores obtained on the BPS scale","definition_or_measurement_approach":"Measured using the BPS questionnaire; endpoint is the score obtained on the BPS scale."}
• {"endpoint_text":"- Frequency of compulsive sexual behavior measured by patient diary data.","definition_or_measurement_approach":"Measured by patient-completed diary entries recording episodes/frequency of compulsive sexual behavior."}
• {"endpoint_text":"- The severity of the perceived “desire” for compulsive sexual behavior","definition_or_measurement_approach":"Severity of perceived desire measured by study instruments/questionnaires as specified in protocol (no further measurement detail provided in JSON)."}

Secondary endpoints

• {"endpoint_text":"- Scores obtained on the CSBD-DI scale.","definition_or_measurement_approach":"Measured using the CSBD-DI questionnaire; endpoint is the score obtained on the CSBD-DI scale."}
• {"endpoint_text":"- Scores obtained on the HADS scale.","definition_or_measurement_approach":"Measured using the HADS questionnaire; endpoint is the score obtained on the HADS scale."}
• {"endpoint_text":"- Scores obtained on the DERS-SF scale.","definition_or_measurement_approach":"Measured using the DERS-SF questionnaire; endpoint is the score obtained on the DERS-SF scale."}
• {"endpoint_text":"- Scores obtained on the IIEF-15 scale.","definition_or_measurement_approach":"Measured using the IIEF-15 questionnaire; endpoint is the score obtained on the IIEF-15 scale."}
• {"endpoint_text":"- Scores obtained on the BIS scale.","definition_or_measurement_approach":"Measured using the BIS questionnaire; endpoint is the score 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":"Behavioral performance in the Incentive Delay Task: reaction time and correctness of performance measured during the 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":"Neuronal indices measured by EEG: amplitude of evoked potentials in the Incentive Delay Task."}
• {"endpoint_text":"- Scores obtained on the CSBD-19 scale","definition_or_measurement_approach":"Measured using the CSBD-19 questionnaire; endpoint is the CSBD-19 score (listed also as a secondary endpoint in protocol)."}
• {"endpoint_text":"- Scores obtained on the BPS scale","definition_or_measurement_approach":"Measured using the BPS questionnaire; endpoint is the BPS score (listed also as a secondary endpoint in protocol)."}
• {"endpoint_text":"- Frequency of compulsive sexual behavior measured by patient diary data.","definition_or_measurement_approach":"Measured by patient diary entries recording frequency (listed also as a secondary endpoint)."}
• {"endpoint_text":"- The severity of the perceived “desire” for compulsive sexual behavior.","definition_or_measurement_approach":"Measured by study instruments/questionnaires assessing severity of perceived desire (listed also as a secondary endpoint)."}

Methods

• Invitation (document: K2_Recruitment material Invitation) — direct invitation material listed among recruitment documents.
• Information leaflet (document: K2_Recruitment material information leaflet) — participant information leaflet for prospective participants.
• Press and internet materials (document: K2_Recruitment material information for the press and the internet) — recruitment via press and internet channels.

Poland

Earliest CTIS Part Ii Submission Date

26-01-2025

Latest Decision Or Authorization Date

19-01-2026

Processing Time Days

358

Number Of Sites

1

Number Of Participants

410

Primary sponsor

Full Name

Centrum Medycznego Ksztalcenia Podyplomowego

Organisation Type

Educational Institution

Country Of Registered Address

Poland

Third parties

• {"country":"Poland","full_name":"Cleandatalabs Sp. z o.o.","duties_or_roles":"Sponsor duties codes: 10, 6, 7 (as listed in CTIS thirdParty entry)","organisation_type":"Pharmaceutical company"}
• {"country":"Poland","full_name":"Cefea Sp. z o.o. S.K.","duties_or_roles":"Roles include code 14 and code 15; code 15 specified as 'Blinding of IMPs'","organisation_type":"Pharmaceutical company"}
• {"country":"Poland","full_name":"Grand Medical Poland Sp. z o.o.","duties_or_roles":"Placebo manufacturing (code 15)","organisation_type":"Pharmaceutical company"}
• {"country":"Poland","full_name":"Verum.De Polska Sp. z o.o.","duties_or_roles":"CTIS Management (code 15) and code 1","organisation_type":"Hospital/Clinic/Other health care facility"}