Benefits of ADHD Treatment in Detained People

ADHD Clinical Trial

Official title:

Benefits of In-prison OROS-methylphenidate vs. Placebo Treatment in Detained People With Attention-deficit/Hyperactivity Disorder: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05842330
• Other study ID #: 32003B_212581
• Status: Recruiting
• Phase: Phase 3
• Start date: March 1, 2024
• Est. completion date: October 30, 2026

Study information

• Verified date: April 2024
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This project aims to compare the efficacy of a three-month in-prison OROS-methylphenidate vs. placebo treatment on the severity of ADHD core symptoms. Secondary outcomes address additional important in-prison and post-prison aspects: 1) reduction in acute events in prison (e.g., disciplinary sanctions, violence, misuse of ADHD treatment), 2) evaluation of the risk of recidivism upon release, 3) three-month side effects of treatment, 4) in- and post-prison adherence to medication, 5) in- and post-prison study retention, 6) in- and post-prison costs-benefits of treatment, and 8) one-year recidivism. The post-prison part of the project will highlight long-lasting benefits of a treatment provided while people are detained.

These research questions will be answered using a randomized controlled trial. After randomization, the participants will undertake three months of treatment with OROS-MPH or placebo (1:1 ratio) while they are incarcerated. Upon release, all participants will be offered the possibility to have the treatment, but they will remain blinded regarding their initial study group. All of them will benefit of a cognitive-behavioral psycho-education program during detention and a cognitive-behavioral therapy after release.

The RCT will provide empirical-based evidence of the benefits of in-prison ADHD treatment using different perspectives: Clinical, behavioral, recidivism-related, and economical. The investigators expect that early detection and treatment of ADHD in prison will be an important public health opportunity and a cost-effective approach, likely to decrease the vulnerability of people living in detention and to promote pathways out criminal involvement.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 30, 2026
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• age between 18 and 65

• good command of French

• going to be released in approx. 4 months at eligibility visit

• endorsing clinical diagnostic criteria for DSM-5 ADHD

• providing written informed consent

Exclusion Criteria:

• presence of an acute uncontrolled comorbid psychiatric disorder

• going in a closed centre after release from prison

• medical contraindication to stimulant prescription

• potential adverse interaction with another medication

• already receive ADHD treatment

• do not plan to stay in Switzerland for at least one year.

Related Conditions & MeSH terms

• ADHD

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	Geneva University Hospitals	Geneva

Sponsors (5)

Lead Sponsor	Collaborator
Stéphanie Baggio	Netherlands Institute for the Study of Crime, School of Health Sciences Fribourg, University of Geneva, Switzerland, University of Lausanne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of side effects	Side effects according to the Swiss compendium (number of side effects)	3 months
Primary	Severity of ADHD core symptoms	Conners Adult ADHD Rating Scale, range 0-78, higher score indicates worse outcome	3 months
Secondary	Number of acute events	Refusal to see doctors, nurses or lawyers, hunger strikes, self-harm events requiring a visit to the medical unit, fights requiring a visit to the medical unit, and disciplinary sanctions	3 months
Secondary	Score of risk of recidivism	Dynamic risk assessment tool will be used to evaluate the risk of recidivism, score 0-30, higher score indicates better outcome	3 months
Secondary	Percentage of adherence to medication	Binary variable (yes=adherence to medication, no=absence of adherence to medication)	3 months and 12 months after release
Secondary	Percentage of retention to study	Binary variable (yes=remain in the study, no=dropout from the study)	12 months after release
Secondary	Costs	Medical costs (costs of medical services used by patients (outpatient, emergency, and inpatient resources) and prison-related costs (disciplinary sanctions, use of resources in the prison and in prison staff and recidivism-related costs, average cost for one day in prison), two quantitative variables in Swiss francs.	3 months (medical and prison-related costs) and 12 months after release (prison-related costs)
Secondary	Number of recividism events	Data from the official Swiss criminal records (Federal Office of Statistics, Criminal Conviction Statistics), binary variable (yes=recidivism, no=no recidivism)	12 months after release