Evaluation of Escitalopram, Paroxetine, Naltrexone, and Combination Therapy in Compulsive Sexual Behavior Disorder: A Randomized Controlled Trial
- Trial ID
- 2024-514490-22-00
- Protocol
- CSBD-TR
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to compare the effects of treatment with **escitalopram**, **paroxetine**, **naltrexone**, and a combination 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, thereby improving patient outcomes and quality of life.
Secondary objectives include:
- Comparison of the effects of these treatments on patients' daily functioning, specifically assessing the severity of perceived anxiety, depressiveness, impulsivity, emotion regulation skills, and the level of sexual dysfunction.
- Verification of the durability of treatment effects in patients with compulsive sexual behavior.
- Comparison of the efficacy of different dosage approaches of the treatments in managing compulsive sexual behaviors.
- Comparison of the effects of these treatments on reactivity to erotic stimuli, 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 documented diagnosis of CSBD according to ICD-11 diagnostic guidelines, a subjective sense of loss of control over sexual behavior, and a willingness to participate in the study procedures. Participants are required to have sought specialized help or therapy, including pharmacotherapy, for their symptoms. The study does not include a vulnerable population, and lifestyle considerations such as diet and physical activity are not specified. The trial aims to compare the effects of treatment with escitalopram, paroxetine, naltrexone, and combined treatment (escitalopram plus naltrexone) or placebo on reducing the severity of CSBD symptoms.
Plans and Procedures
The clinical trial is designed to evaluate the efficacy of pharmacological treatments for **Compulsive Sexual Behaviour Disorder** (CSBD). The study employs a randomized, double-blind, controlled design to compare the effects of **escitalopram**, **paroxetine**, **naltrexone**, and a combination of escitalopram plus naltrexone against a placebo. The primary objective is to assess the reduction in the severity of CSBD symptoms. The trial is expected to commence on October 1, 2024, and conclude by February 28, 2029, with an estimated participant involvement of up to 24 weeks, depending on the treatment group.
Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as male gender, age between 18-60 years, and a documented diagnosis of CSBD according to ICD-11 guidelines. Following successful screening, participants will be randomized into one of the treatment arms. Regular follow-up visits will be scheduled to monitor treatment efficacy and safety, with assessments including scores on the CSBD-19 scale, BPS scale, and patient diary data on compulsive sexual behavior frequency. The end-of-study visit will evaluate the overall treatment outcomes and any adverse events.
Participants may be withdrawn from the study early if they experience significant adverse effects, fail to comply with study procedures, or withdraw consent. The trial's primary endpoints focus on the reduction of CSBD symptoms, while secondary endpoints include various psychological and behavioral assessments. The study aims to provide comprehensive data on the effectiveness of these pharmacological interventions in managing CSBD.
Treatment
The clinical trial involves the administration of several **experimental medications** to evaluate their effects on compulsive sexual behavior disorder. The first medication, **Naltex**, contains **naltrexone hydrochloride** as the active substance. It is provided in the form of a **film-coated tablet** with a dosage strength of 50 mg. 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 24 weeks. The tablets are placed in another capsule, and the primary packaging is altered for the trial.
Another experimental medication used in the trial is **Aciprex**, which contains **escitalopram oxalate**. This medication is also in the form of a **film-coated tablet** with a dosage strength of 10 mg. It is administered orally, with a maximum daily dose of 20 mg and a total maximum dose of 2520 mg over a 24-week treatment period. Similar to Naltex, the tablets are encapsulated, and the primary packaging is modified for the study.
The trial also includes the use of **Parogen**, which contains **paroxetine** as the active ingredient. This medication is provided as a **film-coated tablet** with a dosage strength of 20 mg. It is administered orally, with a maximum daily dose of 40 mg and a total maximum dose of 5040 mg over a 24-week treatment period. The tablets are placed in another capsule, and the primary packaging is changed for the trial.
A **placebo** is also utilized in the study, consisting of capsules containing tablets with microcrystalline cellulose 102 mg and magnesium stearate 5 mg. The placebo is administered orally, with a maximum daily dose of 500 mg and a total maximum dose of 250 mg over a 6-week treatment period. The placebo serves as a comparator to evaluate the efficacy of the experimental medications.
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. Secondary endpoints will further evaluate efficacy through scores on the CSBD-DI, HADS, DERS-SF, IIEF-15, and BIS scales. Additionally, responsiveness to erotic stimulus cues will be measured by behavioral performance in the Incentive Delay Task, and reactivity to cues of erotic stimuli will be assessed by neuronal indices, specifically the amplitude of evoked potentials in EEG, also in the Incentive Delay Task.
The trial will compare the effects of treatment with escitalopram, paroxetine, naltrexone, and a combined treatment of escitalopram plus naltrexone, against a placebo. The efficacy parameters will be collected and analyzed at specified timepoints throughout the trial duration, which is estimated to conclude by February 28, 2029. The trial is categorized as a Phase III clinical trial, indicating a focus on evaluating the effectiveness of the treatments in a larger patient population. The study will employ validated scales and patient-reported outcomes to ensure the reliability and accuracy of the efficacy assessments.
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,
- Documented diagnosis of CSBD according to ICD-11 diagnostic guidelines (WHO, 2022)
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-11 diagnostic guidelines (WHO, 2022)
- 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
- 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.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Poland | Not Yet Recruiting | 01 Oct 2024 | 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 |
|---|---|---|---|---|---|---|
Naltex, 50 mg, tabletki powlekane | Test | TABLETKI POWLEKANE | ORAL | 50 | 24 | PRD416180 |
Aciprex, 10 mg, tabletki powlekane | Test | TABLETKI POWLEKANE | ORAL | 20 | 24 | PRD405264 |
Capsules containing tablets with microcrystalline cellulose 102 245 mg and magnesium stearate 5 mg. | Placebo | N/A | ORAL | 500 | 6 | N/A |
Parogen, 20 mg, tabletki powlekane | Test | TABLETKI POWLEKANE | ORAL | 40 | 24 | PRD11270223 |