Efficacy Study of Methylphenidate and Psychosocial Interventions to Treat Swedish Imprisoned Men With Attention Deficit Hyperactivity Disorder (ADHD) - Full Text View

Sponsor:	Psychiatry Karolinska
Collaborators:	Ministry of Health and Social Affairs, Sweden Stockholm County Council, Sweden
Information provided by:	Psychiatry Karolinska
ClinicalTrials.gov Identifier:	NCT00482313

Purpose

The purpose of this study is to determine whether a combination of methylphenidate and psychosocial interventions are effective in the treatment of ADHD in a group of Swedish imprisoned men diagnosed with ADHD.

Condition	Intervention	Phase
Attention Deficit Hyperactivity Disorder	Drug: PR OROS Methylphenidate Other: Psychosocial intervention Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Single Centre, 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

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Methylphenidate Methylphenidate hydrochloride

U.S. FDA Resources

Further study details as provided by Psychiatry Karolinska:

Primary Outcome Measures:

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. [ Time Frame: After 5 weeks (end of double-blind phase) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Long-term efficacy of PR OROS methylphenidate on ADHD-symptoms, overall functioning, neuropsychological assessments, and quality of life. [ Time Frame: During one year ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	May 2007
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 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. Other: Psychosocial intervention psychosocial intervention
Sugar pill: Placebo Comparator Placebo given orally once daily for 5 weeks.	Drug: Placebo Sugar pill

Detailed Description:

The purpose of this 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482313

Locations

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

Sponsors and Collaborators

Psychiatry Karolinska

Ministry of Health and Social Affairs, Sweden

Stockholm County Council, Sweden

Investigators

Principal Investigator:

Nils Lindefors, MD, PhD

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

More Information

No publications provided

Responsible Party:	Karolinska Institutet, Psychiatry Southwest, Karolinska University Hospital at Huddinge, Stockholm, Sweden ( Nils Lindefors, MD, PhD )
Study ID Numbers:	EudraCT-nr 2006-002553-80
Study First Received:	June 4, 2007
Last Updated:	August 3, 2009
ClinicalTrials.gov Identifier:	NCT00482313 History of Changes
Health Authority:	Sweden: Medical Products Agency

Keywords provided by Psychiatry Karolinska:

Attention Deficit Hyperactivity Disorder
ADHD
Prison
Treatment
Randomized

Double-Blind
Placebo Control
Parallel Assignment
Efficacy Study

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Attention Deficit and Disruptive Behavior Disorders
Methylphenidate
Central Nervous System Stimulants
Dyskinesias

Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Therapeutic Uses
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 04, 2010