Benefits of ADHD Treatment in Detained People

ConditionADHD

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-65

SponsorStéphanie Baggio

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

presence of an acute uncontrolled comorbid psychiatric disorder

medical contraindication to stimulant prescription

potential adverse interaction with another medication

already receive ADHD treatment

Trial design

Design model

Parallel

Treatments tested in this trial

Concerta
Drug
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
Drug
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.

Treatment groups

150 Participants

are divided into 2 treatment groups

Group A: Pharmaceutical intervention (OROS-MPH)Experimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Severity of ADHD core symptoms

Conners Adult ADHD Rating Scale, range 0-78, higher score indicates worse outcome

Time frame

3 months

Secondary outcomes

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

Time frame

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

Time frame

3 months

Percentage of adherence to medication

Binary variable (yes=adherence to medication, no=absence of adherence to medication)

Time frame

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)

Time frame

12 months in outpatient care

Other outcomes

Number of side effects

Side effects according to the Swiss compendium (number of side effects)

Time frame

3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stéphanie Baggio

Lead sponsor

University Hospital, Geneva

Sponsor institution

University of Lausanne

Collaborator

University of Geneva, Switzerland

Collaborator

Netherlands Institute for the Study of Crime and Law Enforcement

Collaborator

School of Health Sciences Fribourg

Collaborator

Source ClinicalTrials.gov

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