[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100503981":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":52,"studyPopulation":44,"armGroups":53,"interventions":65,"overallOfficials":44,"centralContacts":44,"locations":74,"responsibleParty":95,"collaborators":99,"id":109,"slug":110,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":111,"sex":117,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":44,"studyType":123,"phases":124,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":77,"whyStopped":44,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"University Hospital, Geneva","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":35},[9],{"measure":10,"description":11,"timeFrame":12},"Severity of ADHD core symptoms","Conners Adult ADHD Rating Scale, range 0-78, higher score indicates worse outcome","3 months",[14,17,20,24,28,32],{"measure":15,"description":16,"timeFrame":12},"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",{"measure":18,"description":19,"timeFrame":12},"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",{"measure":21,"description":22,"timeFrame":23},"Percentage of adherence to medication","Binary variable (yes=adherence to medication, no=absence of adherence to medication)","3 months and 12 months in outpatient care",{"measure":25,"description":26,"timeFrame":27},"Percentage of retention to study","Binary variable (yes=remain in the study, no=dropout from the study)","12 months in outpatient care",{"measure":29,"description":30,"timeFrame":31},"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 in outpatient care (prison-related costs)",{"measure":33,"description":34,"timeFrame":27},"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)",[36],{"measure":37,"description":38,"timeFrame":12},"Number of side effects","Side effects according to the Swiss compendium (number of side effects)",{"allocation":40,"interventionModel":41,"interventionModelDescription":42,"primaryPurpose":43,"observationalModel":44,"timePerspective":44,"maskingInfo":45},"RANDOMIZED","PARALLEL","This is a phase 3 parallel randomized controlled trial (1:1 ratio) of OROS-MPH vs. a placebo on a clinical outcome.\n\nParticipants 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).","TREATMENT",null,{"masking":46,"maskingDescription":47,"whoMasked":48},"TRIPLE","Participants will be blinded to the 3-month (12 weeks with a one-week window) in-prison treatment.\n\nThe 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.",[49,50,51],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","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.\n\nThese 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.\n\nThe 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.",[54,60],{"label":55,"type":56,"description":57,"interventionNames":58},"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.",[59],"Drug: Concerta",{"label":61,"type":62,"description":44,"interventionNames":63},"Placebo","PLACEBO_COMPARATOR",[64],"Drug: Placebo",[66,71],{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":44},"DRUG","Concerta","Dosages of Concerta® will be defined according to the Swiss Compendium (from 18 to 72 mg\u002Fd).\n\nThe 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.\n\nThe 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.",[55],{"type":67,"name":61,"description":72,"armGroupLabels":73,"otherNames":44},"The placebo will be strictly identical (same packaging, size no. 2 and color according to dosage, with no label).\n\nProcedure for adjustment of dosage will be the same as in the Concerta arm.",[61],[75],{"facility":76,"status":77,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Geneva University Hospitals","RECRUITING","Geneva","Canton of Geneva","1211","Switzerland","CH",{"type":84,"coordinates":85},"Point",[86,87],6.14569,46.20222,{"lat":87,"lon":86},[90],{"name":91,"role":92,"phone":93,"phoneExt":44,"email":94},"Patrick Heller, MD","CONTACT","+41223055218","patrick.heller@hug.ch",{"type":96,"investigatorFullName":97,"investigatorTitle":98,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"SPONSOR_INVESTIGATOR","Stéphanie Baggio","Prof.",[100,102,104,106],{"name":101,"class":6},"University of Lausanne",{"name":103,"class":6},"University of Geneva, Switzerland",{"name":105,"class":6},"Netherlands Institute for the Study of Crime and Law Enforcement",{"name":107,"class":108},"School of Health Sciences Fribourg","UNKNOWN","100503981","phase-3-benefits-of-adhd-treatment-in-detained-people-100503981",false,"NCT05842330","Benefits of ADHD Treatment in Detained People","Benefits of In-prison OROS-methylphenidate vs. Placebo Treatment in Detained People With Attention-deficit\u002FHyperactivity Disorder: A Randomized Controlled Trial","BATIR","Inclusion Criteria:\n\n* age between 18 and 65\n* good command of French\n* stay in prison approx. 4 months at eligibility visit\n* endorsing clinical diagnostic criteria for DSM-5 ADHD\n* providing written informed consent\n\nExclusion Criteria:\n\n* presence of an acute uncontrolled comorbid psychiatric disorder\n* medical contraindication to stimulant prescription\n* potential adverse interaction with another medication\n* already receive ADHD treatment","ALL","18 Years","65 Years",{"count":121,"type":122},150,"ESTIMATED","INTERVENTIONAL",[125],"PHASE3","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.",[128],"ADHD",[130,131,132,133],"Prison","Health care","Adherence to treatment","Recidivism","2026-09-16",{"date":136,"type":137},"2026-09-21","ACTUAL",{"date":139,"type":137},"2024-01-01",{"date":141,"type":122},"2027-10-30",{"name":97,"class":6},1]