Towards the understanding of neuronal mechanisms of compulsive sexual behaviors - pharmacotherapy

Phase 1

• Conditions: compulsive sexual behavior (hypersexual disorder); Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]

• Registration Number: EUCTR2016-002161-56-PL
• Lead Sponsor: Mateusz Gola

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-23
• Last Update Posted: 8 May 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1.Heterosexual male = 18 years old
2.Signed informed consent
3.Perceived loss of control over one’s sexual behavior (pornography use, masturbation, partnered sexual activity, use of commercial sexual services) causing
4.Help/treatment seeking (psychological/psychiatric/sexological/self-help groups/spiritual counseling)
5.Meeting criteria of Hypersexual Disorder by Kafka (2010) – at least 4 out of 5 (A1-A5):
A1. Time consumed by sexual fantasies, urges or behaviors repetitively interferes with other important (non-sexual) goals, activities and obligations.
A2. Repetitively engaging in sexual fantasies, urges or behaviors in response to dysphoric mood states (e.g., anxiety, depression, boredom, irritability).
A3. Repetitively engaging in sexual fantasies, urges or behaviors in response to stressful life events.
A4. Repetitive but unsuccessful efforts to control or significantly reduce these sexual fantasies, urges or behaviors.
A5. Repetitively engaging in sexual behaviors while disregarding the risk for physical or emotional harm to self or others.
with
B.Significant personal distress or impairment in social, occupational or other important areas of functioning associated with the frequency and intensity of these sexual fantasies, urges or behaviors
C.These sexual fantasies, urges or behaviors are not due to the direct physiological effect of an exogenous substance (e.g., a drug of abuse or a medication)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Concomittant mania, bipolar disorder, psychotic disorders, obsessive-compulsive disorder or cognitive impairment according to ICD-10 diagnostic criteria
2.Current use of any antidepressant, anxiolytic, antipsychotic or mood stabilizing medication
3.Current psychotherapy
4.History of any neurological disease
5.Substance abuse or pathological gambling
6.Medical contraindications for the use of paroxetine or naltrexone hydrochloride (according to medicinal product characteristics)
and (because of planned fMRI examination):
7.Implanted metal, electric or electronic devices (heart pacemaker, insulin pump, metal clips etc.)
8.Claustrophobia
9.Tattoos covering face area

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To check if medication applied in accordance with current knowledge on the neuronal mechanisms of compulsive sexual behavior leads to a significant reduction of symptoms of this disorder;Secondary Objective: Evaluation of the influence of the medication on particular aspects related to compulsive sexual behavior (e.g. behavioral control, impulsivity, frequency of compulsive sexual behavior, mood regulation, brain response to erotic cues);Primary end point(s): Scores (change) in questionnaires: Sex Addiction Screening Test (SAST), Sexual Arousability Inventory (SAI), Multidimensional Sexuality Questionnaire (MSQ), Impulsivity Questionnaire (IVE);Timepoint(s) of evaluation of this end point: Baseline, after 8 and 20 weeks of treatment, 20 weeks after completion of the medication

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Changes within amygdala and ventral striatum activity in response to visual stimulation using standardized visual sexual cues;Timepoint(s) of evaluation of this end point: Baseline, after 20 weeks of medication, 20 weeks after completion of the medication