FLUOXETINE for Pedophilic disorder | Hebephilia

Inclusion criteria

• {"criterion_text":"- 1. Signed informed consent form.\n- 2. Aged 18-65 years.\n- 3. Male.\n- 4. Able to read and communicate in Swedish.\n- 5. Have access to computing device and internet.\n- 6. Meet criteria for pedophilic disorder (per DSM-5) or hebephilia.\n- 7. Agree to participate in all trial visits including providing blood and urine samples."}

Exclusion criteria

• {"criterion_text":"- 1. Severe psychiatric disorder requiring immediate treatment such as current psychosis or severe depression.\n- 2. Contact-driven, loss of control over such impulses, and access to children.\n- 3. Self-reported use of recreational drugs in the past month or positive drug verification analysis.\n- 4. Alcohol dependence or risk consumption (> 14 units of alcohola per week) in the past month.\n- 5. Participation in other trials or studies outside ANOVA.\n- 6. Signs of hepatitis, elevated liver enzymes (> 3 times reference values), or a history of liver failure.\n- 7. eGFR < 60 ml/min, signs or history of acute kidney failure.\n- 8. Fasting plasma glucose ≥ 7.0 mmol/l (126 mg/dl).\n- 9. Ongoing treatment in the past month with opioids or benzodiazepines. A restricted level of intermittent treatment is tolerated if it does not interfere with the trial treatment (as judged by trial psychiatrist).\n- 10. Ongoing treatment in the past month with oral anticoagulants such as warfarin. Intermittent treatment (max. 15 doses per week) with NSAID (eg, ibuprofen) is tolerated.\n- 11. Treatment with tamoxifen.\n- 12. Bipolar disorder or history of hypomania.\n- 13. Known heart disease such as angina pectoris, previous heart failure, or heart attack.\n- 14. Other serious physical illness including diabetes mellitus, epilepsy, or known ocular hypertension.\n- 15. Ongoing treatment with, or previous hypersensitivity reaction to, SSRI.\n- 16. Change of concurrent medication or dosage in the past three months regarding antidepressants, ADHD medication, mood stabilizers, antipsychotics, cortisone, testosterone, or dopamine precursors. Smaller adjustments may in some cases be acceptable (assessed by trial psychiatrist).\n- 17. Ongoing pharmacological treatment with contraindicated substances (eg, MAOI, metoprolol).\n- 18. Ongoing psychotherapeutic treatment.\n- 19. Mental health condition that could negatively influence either the participant’s health or the scientific aspects of the trial (eg, intellectual disability)."}

Primary endpoints

• {"endpoint_text":"- 14 weeks from randomization","definition_or_measurement_approach":""}

Sweden

Earliest CTIS Part Ii Submission Date

05-04-2024

Latest Decision Or Authorization Date

17-06-2024

Processing Time Days

73

Number Of Sites

1

Number Of Participants

111

Primary sponsor

Full Name

Karolinska University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden