RecruitingPhase 3NCT05842330

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


Sponsor

Stéphanie Baggio

Enrollment

150 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

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. However, to date, ADHD treatment has been neglected in prison. This project will test the efficacy of ADHD treatment using a randomized controlled trial.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

  • 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 Criteria4

  • presence of an acute uncontrolled comorbid psychiatric disorder
  • medical contraindication to stimulant prescription
  • potential adverse interaction with another medication
  • already receive ADHD treatment

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Interventions

DRUGConcerta

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.

DRUGPlacebo

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

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NCT05842330


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