PARACHUTES: Pedophilia At Risk – Acute Treatment – E-therapy vs SSRI
EU CTIS ID: 2024-513388-16-00
What this study is testing
The primary objective of the trial is to examine whether add-on therapy with fluoxetine or iCBT is more effective than a standalone psychoeducational program for the reduction of problematic sexual behaviors in help-seeking men with sexual interest in children (SIC)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Signed informed consent form. 2. Aged 18-65 years. 3. Male. 4. Able to read and communicate in Swedish. 5. Have access to computing device and internet. 6. Meet criteria for pedophilic disorder (per DSM-5) or hebephilia. 7. Agree to participate in all trial visits including providing blood and urine samples.
You likely can't join if
- 1. Severe psychiatric disorder requiring immediate treatment such as current psychosis or severe depression. 2. Contact-driven, loss of control over such impulses, and access to children. 3. Self-reported use of recreational drugs in the past month or positive drug verification analysis. 4. Alcohol dependence or risk consumption (> 14 units of alcohola per week) in the past month. 5. Participation in other trials or studies outside ANOVA. 6. Signs of hepatitis, elevated liver enzymes (> 3 times reference values), or a history of liver failure. 7. eGFR < 60 ml/min, signs or history of acute kidney failure. 8. Fasting plasma glucose ≥ 7.0 mmol/l (126 mg/dl). 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). 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. 11. Treatment with tamoxifen. 12. Bipolar disorder or history of hypomania. 13. Known heart disease such as angina pectoris, previous heart failure, or heart attack. 14. Other serious physical illness including diabetes mellitus, epilepsy, or known ocular hypertension. 15. Ongoing treatment with, or previous hypersensitivity reaction to, SSRI. 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). 17. Ongoing pharmacological treatment with contraindicated substances (eg, MAOI, metoprolol). 18. Ongoing psychotherapeutic treatment. 19. Mental health condition that could negatively influence either the participant’s health or the scientific aspects of the trial (eg, intellectual disability).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.