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

NCT00482313 | Completed Phase 3 DMC

• 1 other identifier: EudraCT-nr 2006-002553-80
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity Disorder; ADHD; Prison; Treatment; Randomized; Double-Blind; Placebo Control; Parallel Assignment; Efficacy Study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

  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.

  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

Study Arms (2)

Methylphenidate

EXPERIMENTAL

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

Sugar pill

PLACEBO COMPARATOR

Placebo given orally once daily for 5 weeks.

Drug: Placebo

Interventions

PR OROS Methylphenidate 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.

Also known as: Concerta

Methylphenidate

Placebo DRUG

Sugar pill

Sugar pill

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Psychiatry Karolinska: lead
• Ministry of Health and Social Affairs, Sweden: collaborator
• Region Stockholm: collaborator

Study Sites (1)

Stockholm County Council, Psychiatry Southwest Karolinska

Huddinge, Stockholm County, 141 86, Sweden

Location

Related Publications (2)

• 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.

  PMID: 26284932 DERIVED

• 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.

  PMID: 22075648 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Nils Lindefors, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 4, 2007
• First Posted: June 5, 2007
• Study Start: May 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: May 10, 2010

Record last verified: 2009-08

Locations

SE (1)