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Benefits of ADHD Treatment in Detained People

NCT05842330 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-03-17

No results posted yet for this study

Summary

Attention deficit hyperactivity disorder (ADHD) is characterized by difficulties paying attention, poor impulse control, and hyperactive behaviors. It is associated with several health and social detrimental outcomes and leads to increased risks of criminality and recidivism. However, to date, ADHD treatment has been neglected in prison. This project will test the efficacy of ADHD treatment using a randomized controlled trial.

Conditions

  • ADHD

Interventions

DRUG

Concerta

Dosages of Concerta® will be defined according to the Swiss Compendium (from 18 to 72 mg/d). The psychiatrist will start with the smallest dosage (18 mg) and will adapt it on a weekly basis or on need, depending on tolerance (side effects measured at each visit), clinical response (subjective improvement felt by the patient in terms of attention, impulsivity, and hyperactivity), and according to the observations made by the professionals or patient's entourage in term of attention, impulsivity, hyperactivity, and for this project, behavioral problems. In general, the dose can be increased in 18 mg at weekly intervals. The treatment will be monitored weekly the first month, and then monthly, except for side effects which will be monitored daily in prison and every two weeks after release.

DRUG

Placebo

The placebo will be strictly identical (same packaging, size no. 2 and color according to dosage, with no label). Procedure for adjustment of dosage will be the same as in the Concerta arm.

Sponsors & Collaborators

  • University of Lausanne

    collaborator OTHER

  • University of Geneva, Switzerland

    collaborator OTHER

  • Netherlands Institute for the Study of Crime

    collaborator UNKNOWN

  • School of Health Sciences Fribourg

    collaborator UNKNOWN

  • Stéphanie Baggio

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2026-10-30
Completion
2027-10-30

Countries

  • Switzerland

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05842330 on ClinicalTrials.gov