Evaluation of Escitalopram, Naltrexone, and Their Combination Versus Placebo in Reducing Symptoms of Compulsive Sexual Behavior Disorder
- Trial ID
- 2024-514490-22-01
- Protocol
- CSBD-TR
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to compare the effects of treatment with **escitalopram**, **naltrexone**, and a combined treatment of escitalopram plus naltrexone or placebo on reducing the severity of symptoms in patients with **Compulsive Sexual Behaviour Disorder** (CSBD). This is clinically relevant as it aims to identify the most effective pharmacological intervention for alleviating the symptoms associated with CSBD, which can significantly impact patients' quality of life.
Secondary objectives include:
- Comparison of the effects of treatment with escitalopram, naltrexone, and combined treatment on characteristics of patients' daily functioning, such as the severity of perceived anxiety, depressiveness, impulsivity, emotion regulation skills, and the level of sexual dysfunction.
- Verification of the durability of treatment effects with escitalopram, naltrexone, and combination treatment with escitalopram with naltrexone or placebo in a group of patients with compulsive sexual behavior.
- Comparison of the efficacy of different dosage approaches of escitalopram, naltrexone, and combination treatment of escitalopram with naltrexone or placebo in the treatment of patients with compulsive sexual behaviors.
- Comparison of the effects of treatment with escitalopram, naltrexone, and combination treatment with escitalopram and naltrexone on reactivity to erotic stimuli as measured by behavioral (reaction times) and neuronal (EEG evoked potentials) indicators.
Participants
The clinical trial focuses on **Compulsive Sexual Behaviour Disorder** and involves a study population exclusively composed of male participants aged 18 to 60 years. The sponsor has not provided the total number of participants. The trial population was selected based on specific criteria, including a subjective sense of loss of control over sexual behavior and a diagnosis of CSBD according to ICD-11 guidelines. Participants are required to have a score of 50 points or higher on the CSBD-19 questionnaire. The study does not include a vulnerable population, and participants must adhere to contraception rules if engaging in sexual relations with a partner who could potentially become pregnant. The trial aims to compare the effects of treatment with escitalopram, naltrexone, and a combination of both, against a placebo, in reducing the severity of CSBD symptoms.
Plans and Procedures
The clinical trial is designed to evaluate the efficacy of **escitalopram oxalate**, **naltrexone hydrochloride**, and their combination in treating **Compulsive Sexual Behaviour Disorder** (CSBD). This is a Phase III, randomized, double-blind, placebo-controlled study. The trial aims to compare the effects of these treatments on reducing the severity of CSBD symptoms. The study is expected to commence on February 1, 2025, and conclude by February 28, 2029, with an estimated participant involvement of up to 24 weeks, depending on the treatment group assignment.
Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on criteria such as age, gender, and CSBD diagnosis according to ICD-11 guidelines. Following successful screening, participants will be randomized into one of four groups: escitalopram, naltrexone, combined treatment, or placebo. The trial will include regular follow-up visits to monitor treatment efficacy and safety, with assessments including the CSBD-19 scale, BPS scale, and patient diaries to track compulsive sexual behavior frequency. The end-of-study visit will evaluate the primary and secondary endpoints, including changes in CSBD symptom severity and responsiveness to erotic stimuli.
Participants are expected to adhere to the study protocol, including the use of contraception to prevent drug exposure to partners who could become pregnant. Conditions that may lead to early termination from the study include non-compliance with the protocol, adverse events, or withdrawal of consent. The trial's primary endpoints focus on the reduction of CSBD symptoms, while secondary endpoints include various psychological and behavioral assessments. The study's design ensures rigorous evaluation of the treatments' effectiveness and safety in managing CSBD.
Treatment
The clinical trial involves the administration of **Naltex**, a pharmaceutical product containing **naltrexone hydrochloride** as the active substance. Naltex is provided in the form of film-coated tablets, each containing 50 mg of the active ingredient. The medication is administered orally, with a maximum daily dose of 50 mg and a total maximum dose of 7300 mg over a treatment period of up to 24 weeks. The tablets are placed in another capsule, and the primary packaging is altered for the trial. The product is manufactured by Accord Healthcare Polska Sp. z o.o. and is classified under the ATC code N07BB04.
Another treatment used in the trial is **Aciprex**, which contains **escitalopram oxalate** as the active substance. Aciprex is also provided in the form of film-coated tablets, with each tablet containing 10 mg of the active ingredient. The administration route is oral, with a maximum daily dose of 20 mg and a total maximum dose of 2520 mg over a treatment period of up to 24 weeks. Similar to Naltex, the tablets are placed in another capsule, and the primary packaging is modified for the study. This product is manufactured by Biofarm Sp. z o.o. and is classified under the ATC code N06AB10.
The trial also includes a placebo group, where participants receive capsules containing tablets with microcrystalline cellulose 102 mg and magnesium stearate 5 mg. These capsules are administered orally, with a maximum daily dose of 500 mg and a total maximum dose of 250 mg over a treatment period of up to 6 weeks. The placebo is used to compare the effects of the active treatments on reducing the severity of symptoms in compulsive sexual behavior disorder (CSBD).
Efficacy
Efficacy in the clinical trial for the pharmacological treatment of **compulsive sexual behavior disorder (CSBD)** will be assessed using a combination of primary and secondary endpoints. The primary endpoints include scores obtained on the CSBD-19 scale, the BPS scale, the frequency of compulsive sexual behavior as measured by patient diary data, and the severity of the perceived "desire" for compulsive sexual behavior. These measures will provide a comprehensive evaluation of symptom severity and behavioral patterns associated with CSBD.
Secondary endpoints will further assess efficacy through additional scales and tasks. These include scores on the CSBD-DI, HADS, DERS-SF, IIEF-15, and BIS scales. Behavioral performance in response to erotic stimulus cues will be measured using the Incentive Delay Task, focusing on reaction time and correctness of performance. Neuronal indices, such as the amplitude of evoked potentials in EEG, will also be evaluated in response to erotic stimuli during the Incentive Delay Task. The secondary endpoints will provide a broader understanding of the treatment's impact on emotional regulation, anxiety, depression, and sexual function.
The trial will involve a comparison of treatment effects using escitalopram, naltrexone, a combination of both, and a placebo. The efficacy parameters will be collected and analyzed at specified timepoints throughout the trial duration, ensuring a robust assessment of the treatment's impact on CSBD symptoms and related behaviors.
Inclusion and Exclusion Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Poland | Recruiting | 01 Feb 2025 | 410 |
Sites & Investigators
Research sites
Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Capsules containing tablets with microcrystalline cellulose 102 245 mg and magnesium stearate 5 mg. | Placebo | N/A | ORAL | 500 | 6 | N/A |
NALTREXONE HYDROCHLORIDE | Test | — | ORAL | 50 | 24 | SUB14629MIG |
ESCITALOPRAM OXALATE | Test | — | ORAL | 20 | 24 | SUB16426MIG |