Pharmacological treatment of compulsive sexual behaviour disorder

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centrum Medycznego Ksztalcenia Podyplomowego

Participant type

Patients

Age range

18-64 years

Gender

Male

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03], Psychiatry and Psychology [F] - Psychological Phenomena [F02], Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01]

Trial duration

12 Jun 2025 → ongoing

Decision date (initial)

2025-02-24

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Agencja Badań Medycznych (ABM)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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.

Secondary objectives 4

1. Comparison of the effects of treatment with escitalopram, naltrexone, and combined treatment (escitalopram plus naltrexone) on characteristics of patients' daily functioning (i.e. the severity of perceived anxiety, depressiveness, impulsivity, emotion regulation skills and the level of sexual dysfunction).
2. 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.
3. 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
4. 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.

Conditions and MedDRA coding

Compulsive Sexual Behaviour Disorder

Regulatory references

Plan to share IPD

No

IPD plan description

N/A

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Male gender and age 18-60 years
2. Signed informed consent form for participation in the study and consent to the processing of personal data
3. Declared willingness to participate in the procedures included in the study protocol
4. Subjective sense of loss of control over one's sexual behavior (e.g., viewing pornography, masturbation, or use of paid sexual services, etc.),
5. Seeking specialized help/therapy including pharmacotherapy for perceived symptoms or consequences of the symptoms,
6. 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
7. Achieving a score of 50 points or higher on the CSBD-19 questionnaire
8. 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 9

1. 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)
2. 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.
3. Current use of antidepressant, anti-anxiety, antipsychotic or mood-stabilizing medications
4. Clinically significant neurological disorders reported in the medical history
5. Current psychoactive substance dependence, compulsive gambling
6. Positive drug test result
7. Any medical contraindication to the use of escitalopram or naltrexone hydrochloride (according to summary of product characteristics)
8. Use of other drugs that have clinically significant or pharmacokinetic interactions with the investigational medicinal products
9. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Scores obtained on the CSBD-19 scale
2. Scores obtained on the BPS scale
3. Frequency of compulsive sexual behavior measured by patient diary data.
4. The severity of the perceived “desire” for compulsive sexual behavior

Secondary endpoints 11

1. Scores obtained on the CSBD-DI scale.
2. Scores obtained on the HADS scale.
3. Scores obtained on the DERS-SF scale.
4. Scores obtained on the IIEF-15 scale.
5. Scores obtained on the BIS scale.
6. Responsiveness to erotic stimulus cues measured by behavioral performance (reaction time and correctness of performance) in the Incentive Delay Task
7. Reactivity to cues of erotic stimuli measured by neuronal indices (amplitude of evoked potentials in EEG) in the Incentive Delay Task
8. Scores obtained on the CSBD-19 scale
9. Scores obtained on the BPS scale
10. Frequency of compulsive sexual behavior measured by patient diary data.
11. The severity of the perceived “desire” for compulsive sexual behavior.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centrum Medycznego Ksztalcenia Podyplomowego

Sponsor organisation

Centrum Medycznego Ksztalcenia Podyplomowego

Address

Ul. Ulica Marymoncka 99/103

City

Warsaw

Postcode

01-813

Country

Poland

Scientific contact point

Organisation

Centrum Medycznego Ksztalcenia Podyplomowego

Contact name

Krzysztof J. Filipiak

Public contact point

Organisation

Centrum Medycznego Ksztalcenia Podyplomowego

Contact name

Krzysztof J. Filipiak

Third parties 4

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 22 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

9 submissions — initial application plus substantial / non-substantial modifications