Efficacy and Effectiveness of Methylphenidate in Swedish Male Prison Inmates With Attention-deficit Hyperactivity Disorder (ADHD)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and effectiveness of methylphenidate in treatment of ADHD in Swedish adult male prison inmates diagnosed with ADHD.

Detailed Description
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The purpose of this study is to evaluate the efficacy of Prolonged Release (PR) OROS methylphenidate in fixed dosage as compared to placebo, and the effectiveness of flexible dosage Prolonged Release (PR) OROS methylphenidate in Swedish adult male prison inmates with attention-deficit hyperactivity disorder (ADHD). An initial randomised, double-blind, placebo-controlled parallel group trial for 5 weeks is followed by an open-label extension for maximum 47 weeks, comprising altogether 52 weeks of treatment. A follow-up is carried out 12 and 36 months post-study, respectively.

Official Title
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A Single Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Efficacy of PR OROS Methylphenidate Followed by Open-Label Extension, in Swedish Male Prison Inmates With ADHD

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Drug: PR OROS Methylphenidate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male, 18-65 years, imprisoned at Norrtalje Prison WURS-score of 36 or more and fulfilling at least 4 out of 6 criteria on ASRS Screener in an initial screening preceding the trial Can read and understand Swedish well enough to participate in the evaluation preceding the trial Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition, (DSM-IV) and confirmed by the neuropsychiatric assessment including structured diagnostic interviews and neuropsychological measurements. At least 14 months left to conditional release. Informed Consent Form to participate in the study signed by the subject. Subject agrees to take only the supplied study drug as treatment for ADHD during the study Subject is able to comply with the study visit schedule and willing and able to complete the protocol-specified assessments. Healthy on the basis of a physical examination and the results of blood biochemistry tests. If the results of the biochemistry tests are not within the normal reference ranges, the subject may be included if the investigator considers the deviations are not clinically relevant. Exclusion Criteria: Known to be a non-responder to methylphenidate. Known allergy or hypersensitivity to methylphenidate. Any clinically unstable psychiatric condition including, but not limited to, acute mood disorder, bipolar disorder, acute OCD. A diagnosis of substance use disorder (abuse/dependence) according to DSM-IV criteria within 3 months prior to screening evaluation for the study. Known mental retardation. Subjects with history of epileptic seizures, glaucoma, uncontrolled hypertension, angina pectoris, cardiac arrhythmias or structural heart abnormalities. Use of monoamine oxidase inhibitors, fluoxetine, venlafaxine, reboxetine, duloxetine. Use of alpha-2-receptor agonists, neuroleptics, theophylline, coumarin anticoagulants or anticonvulsants. Liver or renal insufficiency. Subjects with hepatitis C without liver insufficiency don´t have to be excluded as long as liver enzymes are followed through the study. Subjects who are suicidal. Lactose intolerance.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methylphenidate<br>PR OROS Methylphenidate given orally once daily for 5 weeks. The dosage was as follows: 36 mg per day from day 1-3, 54 mg per day from day 4-7 and 72 mg per day from day 8 until end of 5th week. | Drug: PR OROS Methylphenidate<br>* PR OROS Methylphenidate given orally once daily for 5 weeks. The dosage was as follows: 36 mg per day from day 1-3, 54 mg per day from day 4-7 and 72 mg per day from day 8 until end of 5th week.<br>* Other names: Concerta;|
| Placebo Comparator: Sugar pill<br>Placebo given orally once daily for 5 weeks. | Drug: Placebo<br>* Sugar pill<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of PR OROS methylphenidate on ADHD-symptoms in adult male prison inmates with ADHD, as measured by changes from baseline until endpoint in the observer-rated CAARS. | ADHD-symptoms as measured by changes in the observer-rated CAARS from baseline until endpoint at week 5. | Changes from baseline until endpoint at week 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term effectiveness of PR OROS methylphenidate as measured by changes from baseline until endpoint in ADHD-symptoms, global functioning, neuropsychological functioning, and quality of life in adult male prison inmates with ADHD. | ADHD-symptoms as measured by changes in the observer-rated CAARS, and by the self-reported ASRS until endpoint at week 52. Global functioning as measured by changes in CGI-S and GAF until endpoint at week 52. Neuropsychological functioning, as measured by changes in the Conners CPT II, the QbTestPlus, Digit Span and Span Board from baseline until endpoint at week 52. Quality of Life as measured by changes in the Quality of Life Inventory from baseline until endpoint at week 52. | From baseline until endpoint at week 52 | 
| Efficacy of PR OROS methylphenidate on ADHD-symptoms and global functioning in adult male prison inmates with ADHD, as measured by changes from baseline until endpoint in self-reported ASRS, CGI-S and GAF |  | From baseline until endpoint at week 5 | 
| Safety parameters, as measured by changes in pulse, blood pressure, weight and blood chemistry, from baseline until endpoint. | Blood chemistry included counting of red blood cells, white blood cells, blood platelets, and liver enzymes (ALAT, ASAT). | From baseline until endpoint at week 52 | 
| Safety parameters as collection of reported adverse events from baseline until endpoint |  | From baseline until endpoint at week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Attention Deficit Hyperactivity Disorder, ADHD, Prison, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study