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

NCT ID: NCT00482313

Last Updated: 2010-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2010-04-30

Brief 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.

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.

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Methylphenidate

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.

Group Type: EXPERIMENTAL

PR OROS Methylphenidate

Intervention Type: DRUG

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.

Sugar pill

Placebo given orally once daily for 5 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Sugar pill

Interventions

PR OROS Methylphenidate

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.

Intervention Type: DRUG

Placebo

Sugar pill

Intervention Type: DRUG

Other Intervention Names

Concerta

Eligibility 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 don´t have to be excluded as long as liver enzymes are followed through the study.
• Subjects who are suicidal.
• Lactose intolerance.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health and Social Affairs, Sweden

OTHER_GOV

Sponsor Role: collaborator

Region Stockholm

OTHER_GOV

Sponsor Role: collaborator

Psychiatry Karolinska

OTHER

Sponsor Role: lead

Responsible Party

Karolinska Institutet, Psychiatry Southwest, Karolinska University Hospital at Huddinge, Stockholm, Sweden

Principal Investigators

Nils Lindefors, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet, Psychiatry Southwest, Karolinska University Hospital at Huddinge, Stockholm, e-mail: nils.lindefors@sll.se

Locations

Stockholm County Council, Psychiatry Southwest Karolinska

Huddinge, Stockholm County, Sweden

Countries

Sweden

References

Ginsberg Y, Langstrom N, Larsson H, Lindefors N. Long-Term Treatment Outcome in Adult Male Prisoners With Attention-Deficit/Hyperactivity Disorder: Three-Year Naturalistic Follow-Up of a 52-Week Methylphenidate Trial. J Clin Psychopharmacol. 2015 Oct;35(5):535-43. doi: 10.1097/JCP.0000000000000395.

Reference Type: DERIVED

PMID: 26284932 (View on PubMed)

Ginsberg Y, Lindefors N. Methylphenidate treatment of adult male prison inmates with attention-deficit hyperactivity disorder: randomised double-blind placebo-controlled trial with open-label extension. Br J Psychiatry. 2012 Jan;200(1):68-73. doi: 10.1192/bjp.bp.111.092940. Epub 2011 Nov 10.

Reference Type: DERIVED

PMID: 22075648 (View on PubMed)

Other Identifiers

EudraCT-nr 2006-002553-80

Identifier Type: -

Identifier Source: org_study_id