Benefits of ADHD Treatment in Detained People

NCT05842330 | Recruiting Phase 3 DMC

• 1 other identifier: 32003B_212581
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Prison; Health care; Adherence to treatment; Recidivism

Outcome Measures

Primary Outcomes (1)

• Severity of ADHD core symptoms

  Conners Adult ADHD Rating Scale, range 0-78, higher score indicates worse outcome

  3 months

Secondary Outcomes (6)

• Number of acute events

  3 months

• Score of risk of recidivism

  3 months

• Percentage of adherence to medication

  3 months and 12 months in outpatient care

• Percentage of retention to study

  12 months in outpatient care

• Costs

  3 months (medical and prison-related costs) and 12 months in outpatient care (prison-related costs)

Other Outcomes (1)

• Number of side effects

  3 months

Study Arms (2)

Pharmaceutical intervention (OROS-MPH)

EXPERIMENTAL

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.

Drug: Concerta

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Concerta DRUG

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.

Pharmaceutical intervention (OROS-MPH)

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• presence of an acute uncontrolled comorbid psychiatric disorder
• medical contraindication to stimulant prescription
• potential adverse interaction with another medication
• already receive ADHD treatment

Sponsors & Collaborators

• University of Geneva, Switzerland: collaborator
• Netherlands Institute for the Study of Crime: collaborator
• School of Health Sciences Fribourg: collaborator
• Stéphanie Baggio: lead
• University of Lausanne: collaborator

Study Sites (1)

Geneva University Hospitals

Geneva, Canton of Geneva, 1211, Switzerland

RECRUITING

Related Publications (1)

• Baggio S, Billieux J, Dirkzwager A, Iglesias K, Moschetti K, Perroud N, Schneider M, Vernaz N, Wolff H, Heller P. Protocol of a monocentric, double-blind, randomized, superiority, controlled trial evaluating the effect of in-prison OROS-methylphenidate vs. placebo treatment in detained people with attention-deficit hyperactivity disorder (BATIR). Trials. 2024 Jan 4;25(1):23. doi: 10.1186/s13063-023-07827-7.

  PMID: 38178233 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Treatment Adherence and Compliance; Recidivism

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Health Behavior; Behavior; Criminal Behavior

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to the 3-month (12 weeks with a one-week window) in-prison treatment. The research team and statistician will be blinded to the participants' group. The psychiatrist will be unblinded when participants are released. At that time of the study, all participants will be offered to have the treatment (OROS-MPH) without being unblinded regarding their initial group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Model Details: This is a phase 3 parallel randomized controlled trial (1:1 ratio) of OROS-MPH vs. a placebo on a clinical outcome. Participants will undertake three months (12 weeks with a one-week window) of treatment while they are incarcerated. After three months, all participants will be offered treatment in outpatient care, either in prison or in the community. They will have daily monitoring of medical adherence in prison or in electronic monitors after release (without being unblinded on the treatment they received during detention). They will be followed-up for twelve months as outpatient care (total study duration: 15 months).

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: May 6, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)