ADHDPhase 3BATIRNCT05842330
Benefits of ADHD Treatment in Detained People
A Phase 3 study testing Concerta in people with ADHD, run by Stéphanie Baggio at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- ADHD
- What is being tested?
- Concerta
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2024to 30 Oct 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- presence of an acute uncontrolled comorbid psychiatric disorder
- medical contraindication to stimulant prescription
- potential adverse interaction with another medication
- already receive ADHD treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Geneva University Hospitals
Geneva, Canton of Geneva, 1211
Patrick Heller, MD, +41223055218, patrick.heller@hug.ch
About this study
Official title: Benefits of In-prison OROS-methylphenidate vs. Placebo Treatment in Detained People With Attention-deficit/Hyperactivity Disorder: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- ADHD
- Being tested
- Concerta, Placebo
- Keywords
- Prison, Health care, Adherence to treatment, Recidivism
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Treatment Adherence and Compliance, Recidivism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConcertaDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Concerta |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of ADHD core symptoms
Conners Adult ADHD Rating Scale, range 0-78, higher score indicates worse outcome
Measured: 3 months
Secondary outcomes (6)
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
Measured: 3 months
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
Measured: 3 months
Percentage of adherence to medication
Binary variable (yes=adherence to medication, no=absence of adherence to medication)
Measured: 3 months and 12 months in outpatient care
Percentage of retention to study
Binary variable (yes=remain in the study, no=dropout from the study)
Measured: 12 months in outpatient care
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.
Measured: 3 months (medical and prison-related costs) and 12 months in outpatient care (prison-related costs)
Number of rule-breaking events
Composite outcome with sanctions recorded in prison and recidivism from the official Swiss criminal records (Federal Office of Statistics, Criminal Conviction Statistics) after release, binary variable (yes=rule-breaking behaviour, no=no rule-breaking behaviour)
Measured: 12 months in outpatient care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Jan 2024
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stéphanie Baggio
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne, University of Geneva, Switzerland, Netherlands Institute for the Study of Crime and Law Enforcement, School of Health Sciences Fribourg
- Responsible party
- Sponsor-investigator, Stéphanie Baggio, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842330
- Sponsor's protocol ID
- 32003B_212581
- Acronym
- BATIR
- Status last verified
- Sep 2026
- First submitted
- 5 Apr 2023
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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/s13063-023-07827-7.
PubMed 38178233