Cesar - an open, randomized controlled phase II study, comparing Naltrexon and Fluoxetin treating Compulsive Sexual Behavior Disorder.

Karolinska Universitetssjukhuset0 个研究点目标入组 80 人开始时间: 2020年6月1日最近更新: 2020年10月19日

适应症

试验速览

暂无简介。

•- Age 18 - 65 years
•- Signed Informed Consent
•- Able to understand Swedish language, written and spoken. Be able to use internet.
•- Willingness to attend all visits including blood sampling and urine analysis
•- Fulfill the criterias of Compulsive Sexual Behaviour Disorder
•- Women of childbearing potential must practice a highly effective method of birth control throughout the study
•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 80
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- AST and ALT greater than 3 x ULN
•- Ongoing treatment with opioids or benzodiazepines
•- Self reported use of illegal drugs during the last month, or presence of abuse in urine at inclusion
•- Hazardous consumption of alcohol during the last month, or alcohol abuse. AUDIT >8.
•- Severe psychiatric desease e.g. psychosis or major depression with immediate need of helath care
•- History of hepatic- or renal impairment.
•- Severe somatic condition including unstable heart disease or uncontrolled seizures.
•- Current treatment with SSRI or Naltrexone, or history of allergy to these treatments
•- Changes in treatment regimen or doses the last three month of following therapies: anti depressive, ADHD (minor changes weekdays but not weekends may be accepted, as judged by the investigator) antimanic agents, anti psychotic, cortisone, testosterone, L-Dopa
•- Current use of medications which have serious interactions with fluoxetine e.g. MAO-inhibitors, cocillana-etylmorfin and metoprolol.
•- Pregnancy, lactating or inadequate birth control within women of childbearing potential.
•- Current psychotherapy. Family counselling may be accepted, as judged by the study psychologist.
•- Any psychological condition that may interfere the patients health or the scientific parts of the study, e.g. intelectual disability
•- Already enrolled into a clinical trial

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