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

Information source: Psychiatry Karolinska
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Attention Deficit Hyperactivity Disorder

Intervention: PR OROS Methylphenidate (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Psychiatry Karolinska

Official(s) and/or principal investigator(s):
Nils Lindefors, MD, PhD, Principal Investigator, Affiliation: Karolinska Institutet, Psychiatry Southwest, Karolinska University Hospital at Huddinge, Stockholm, e-mail: nils.lindefors@sll.se

Summary

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: 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.

Secondary outcome:

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.

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

Safety parameters, as measured by changes in pulse, blood pressure, weight and blood chemistry, from baseline until endpoint.

Safety parameters as collection of reported adverse events from baseline until endpoint

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Male.

Criteria:

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

donĀ“t have to be excluded as long as liver enzymes are followed through the study.

- Subjects who are suicidal.

- Lactose intolerance.

Locations and Contacts

Stockholm County Council, Psychiatry Southwest Karolinska, Huddinge, Stockholm 141 86, Sweden
Additional Information

Starting date: May 2007
Last updated: May 7, 2010

Page last updated: August 23, 2015

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