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RECRUITINGPhase 3INTERVENTIONAL

Benefits of ADHD Treatment in Detained People

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This 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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - presence of an acute uncontrolled comorbid psychiatric disorder - medical contraindication to stimulant prescription - potential adverse interaction with another medication - already receive ADHD treatment Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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.

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.

Locations (1)

Geneva University Hospitals
Geneva, Canton of Geneva, Switzerland