PARACHUTES: Pedophilia At Risk – Acute Treatment – E-therapy vs SSRI

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Karolinska University Hospital

Participant type

Patients

Age range

18-64 years

Gender

Male

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Trial duration

17 Jun 2024 → ongoing

Decision date (initial)

2024-06-17

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-513388-16-00

EudraCT number

2021-001249-11

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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)

Secondary objectives 1

1. To investigate clinical and sociodemographic parameters associated with SIC. To investigate biological markers associated with SIC. Evaluation of treatment interventions. To evaluate whether add-on therapy with Fluoxetine or iCBT is more effective than a standalone psychoeducational intervention to: (a) Reduce symptoms of psychiatric comorbidity. (b) Reduce perceived loneliness and improve quality of life. (c) Reduce cognitive distortions and emotional congruence with children. To assess for any differences in drop-out rate and adherence between the treatment groups. To assess adverse effects (fluoxetine) and negative effects (iCBT/iPP); to investigate any links between drop-out rates, reported adverse effects, and/or efficacy. To compare any difference in treatment satisfaction between the treatment groups. Evaluation of treatment (general) To investigate whether there are any indications that clinical, psychosocial, or biological factors can predict treatment response, drop-out rate, and adherence to treatment.

Conditions and MedDRA coding

Pedophilic disorder

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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.

Exclusion criteria 1

1. 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).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 14 weeks from randomization

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Karolinska University Hospital

Sponsor organisation

Karolinska University Hospital

Address

Eugeniavagen 3

City

Solna

Postcode

171 64

Country

Sweden

Scientific contact point

Organisation

Karolinska University Hospital

Contact name

josephine savard

Public contact point

Organisation

Karolinska University Hospital

Contact name

josephine savard

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

Application history

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