Efficacy Study of Prolonged Release (PR) OROS Methylphenidate and Psychosocial Interventions in Swedish Imprisoned Men With Attention Deficit Hyperactivity Disorder (ADHD)
Information source: Psychiatry Karolinska
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention Deficit Hyperactivity Disorder
Intervention: PR OROS Methylphenidate and psychosocial interventions (Drug)
Phase: Phase 4
Status: Recruiting
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@ki.se
Overall contact:
Ylva Ginsberg, MD, Phone: +46-8-578 358 50, Email: ylva.ginsberg@ki.se
Summary
The purpose of the study is to evaluate the efficacy of Prolonged Release (PR) OROS
methylphenidate and psychosocial interventions in a sub-group of Swedish imprisoned adult men
with Attention Deficit Hyperactivity Disorder. An initial randomised, double-blind,
placebo-controlled parallel group phase for 5 weeks is followed by an open-label extension
phase for maximum 47 weeks. A follow-up is made 12 and 36 months post-study.
Clinical Details
Official title: A Singelcentre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Efficacy of PR OROS Methylphenidate and Psychosocial Interventions, With Open-Label Extension, in Swedish Imprisoned Adult Men With ADHD.
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Evaluate the efficacy of PR OROS methylphenidate and psychosocial interventions on ADHD-symptoms compared with placebo in imprisoned adult men with ADHD, measured by changes in investigator-rated CAARS.
Secondary outcome: Long-term efficacy of PR OROS methylphenidate on ADHD-symptoms, overall functioning, neuropsychological assessments, and quality of life.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Male, 18-65 years, imprisoned at Norrtälje Prison
- WURS-score of 36 or more and fulfilling at least 4 out of 6 criteria on ASRS Screener
in an initial screening preceeding 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.
Locations and Contacts
Ylva Ginsberg, MD, Phone: +46-8-578 358 50, Email: ylva.ginsberg@ki.se
Stockholm County Council, Psychiatry Southwest Karolinska Huddinge, Stockholm 141 86, Sweden; Recruiting
Ylva Ginsberg, MD, Sub-Investigator
Nils Lindefors, MD, PhD, Principal Investigator
Additional Information
Starting date: May 2007
Ending date: May 2010
Last updated: May 21, 2008
|
