Clinical trial NCT00482313: Efficacy and Effectiveness of Methylphenidate in Swedish Male Prison Inmates With Attention-deficit Hyperactivity Disorder (ADHD)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention Deficit Hyperactivity Disorder
ADHD
Prison
Treatment
Randomized
Double-Blind
Placebo Control
Parallel Assignment
Efficacy Study
Lead sponsor: Psychiatry Karolinska
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Social Affairs, Sweden
name: Region Stockholm
First posted: 2007-06-05
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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.
timeFrame: Changes from baseline until endpoint at week 5
Secondary outcomes:
measure: 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.
timeFrame: From baseline until endpoint at week 52
measure: 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
timeFrame: From baseline until endpoint at week 5
measure: Safety parameters, as measured by changes in pulse, blood pressure, weight and blood chemistry, from baseline until endpoint.
timeFrame: From baseline until endpoint at week 52
measure: Safety parameters as collection of reported adverse events from baseline until endpoint
timeFrame: From baseline until endpoint at week 52
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Stockholm County Council, Psychiatry Southwest Karolinska
state: Stockholm
Study officials:
affiliation: Karolinska Institutet, Psychiatry Southwest, Karolinska University Hospital at Huddinge, Stockholm, e-mail: nils.lindefors@sll.se
name: Nils Lindefors, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.