Benefits of ADHD Treatment in Detained People
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Concerta, Placebo.
- Who it may be relevant to
- Registry conditions: ADHD. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Benefits of In-prison OROS-methylphenidate vs. Placebo Treatment in Detained People With Attention-deficit/Hyperactivity Disorder: A Randomized Controlled Trial
Overview
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.
Detailed 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 outpatient (in-prison or 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 rule-breaking behaviour. The outpatient part of the project will highlight long-lasting benefits of a treatment provided during three months 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. After three months, 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, rule-breaking-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.
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, - 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.
Primary outcome measures
- Severity of ADHD core symptoms [Time frame: 3 months]
Secondary outcome measures (6)
- Number of acute events [Time frame: 3 months]
- Score of risk of recidivism [Time frame: 3 months]
- Percentage of adherence to medication [Time frame: 3 months and 12 months in outpatient care]
- Percentage of retention to study [Time frame: 12 months in outpatient care]
- Costs [Time frame: 3 months (medical and prison-related costs) and 12 months in outpatient care (prison-related costs)]
- Number of rule-breaking events [Time frame: 12 months in outpatient care]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- presence of an acute uncontrolled comorbid psychiatric disorder
- medical contraindication to stimulant prescription
- potential adverse interaction with another medication
- already receive ADHD treatment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Switzerland · 1 center
- Geneva University Hospitals — Geneva
Publications
- 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/s13063-02 PMID 38178233
Identifiers
NCT: NCT05842330 · 32003B_212581