Benefits of In-prison OROS-methylphenidate vs. Placebo Treatment in Detained People With Attention-deficit/Hyperactivity Disorder: A Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• age between 18 and 65
• good command of French
• stay in prison approx. 4 months at eligibility visit
• endorsing clinical diagnostic criteria for DSM-5 ADHD
• providing written informed consent
Locations
Other Locations
Switzerland
Geneva University Hospitals
RECRUITING
Geneva
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2027-10-30
Participants
Target number of participants: 150
Treatments
Experimental: Pharmaceutical intervention (OROS-MPH)
Participants will receive OROS-MPH (Concerta® available in Switzerland as first-line treatment for ADHD). Dosages will be defined according to the Swiss Compendium. The psychiatrist (blinded during detention) will start with the smallest dosage (18 mg, Concerta®). The treatment will be monitored weekly the first month, and then monthly. The pharmacy of the Geneva University Hospitals will be in charge of over-encapsulating medications.
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Collaborators: School of Health Sciences Fribourg, Netherlands Institute for the Study of Crime and Law Enforcement, University of Lausanne, University of Geneva, Switzerland
Leads: Stéphanie Baggio