Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
150 participants
INTERVENTIONAL
2024-01-01
2026-10-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
Participants will undertake three months (12 weeks) 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).
TREATMENT
TRIPLE
Study Groups
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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.
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* medical contraindication to stimulant prescription
* potential adverse interaction with another medication
* already receive ADHD treatment
18 Years
65 Years
ALL
No
Sponsors
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University of Lausanne
OTHER
University of Geneva, Switzerland
OTHER
Netherlands Institute for the Study of Crime
UNKNOWN
School of Health Sciences Fribourg
UNKNOWN
Stéphanie Baggio
OTHER
Responsible Party
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Stéphanie Baggio
Prof.
Locations
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Geneva University Hospitals
Geneva, Canton of Geneva, Switzerland
Countries
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Facility Contacts
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References
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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.
Other Identifiers
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32003B_212581
Identifier Type: -
Identifier Source: org_study_id
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