search
Back to results

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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
PR OROS Methylphenidate
Placebo
Sponsored by
Psychiatry Karolinska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Attention Deficit Hyperactivity Disorder, ADHD, Prison, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Stockholm County Council, Psychiatry Southwest Karolinska

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Methylphenidate

Sugar pill

Arm Description

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.

Placebo given orally once daily for 5 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
ADHD-symptoms as measured by changes in the observer-rated CAARS, and by the self-reported ASRS until endpoint at week 52. Global functioning as measured by changes in CGI-S and GAF until endpoint at week 52. Neuropsychological functioning, as measured by changes in the Conners CPT II, the QbTestPlus, Digit Span and Span Board from baseline until endpoint at week 52. Quality of Life as measured by changes in the Quality of Life Inventory 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
Safety parameters, as measured by changes in pulse, blood pressure, weight and blood chemistry, from baseline until endpoint.
Blood chemistry included counting of red blood cells, white blood cells, blood platelets, and liver enzymes (ALAT, ASAT).
Safety parameters as collection of reported adverse events from baseline until endpoint

Full Information

First Posted
June 4, 2007
Last Updated
May 7, 2010
Sponsor
Psychiatry Karolinska
Collaborators
Ministry of Health and Social Affairs, Sweden, Region Stockholm
search

1. Study Identification

Unique Protocol Identification Number
NCT00482313
Brief Title
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

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Psychiatry Karolinska
Collaborators
Ministry of Health and Social Affairs, Sweden, Region Stockholm

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Attention Deficit Hyperactivity Disorder, ADHD, Prison, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methylphenidate
Arm Type
Experimental
Arm Description
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.
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
Placebo given orally once daily for 5 weeks.
Intervention Type
Drug
Intervention Name(s)
PR OROS Methylphenidate
Other Intervention Name(s)
Concerta
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Sugar pill
Primary Outcome Measure Information:
Title
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.
Description
ADHD-symptoms as measured by changes in the observer-rated CAARS from baseline until endpoint at week 5.
Time Frame
Changes from baseline until endpoint at week 5
Secondary Outcome Measure Information:
Title
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.
Description
ADHD-symptoms as measured by changes in the observer-rated CAARS, and by the self-reported ASRS until endpoint at week 52. Global functioning as measured by changes in CGI-S and GAF until endpoint at week 52. Neuropsychological functioning, as measured by changes in the Conners CPT II, the QbTestPlus, Digit Span and Span Board from baseline until endpoint at week 52. Quality of Life as measured by changes in the Quality of Life Inventory from baseline until endpoint at week 52.
Time Frame
From baseline until endpoint at week 52
Title
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
Time Frame
From baseline until endpoint at week 5
Title
Safety parameters, as measured by changes in pulse, blood pressure, weight and blood chemistry, from baseline until endpoint.
Description
Blood chemistry included counting of red blood cells, white blood cells, blood platelets, and liver enzymes (ALAT, ASAT).
Time Frame
From baseline until endpoint at week 52
Title
Safety parameters as collection of reported adverse events from baseline until endpoint
Time Frame
From baseline until endpoint at week 52

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nils Lindefors, MD, PhD
Organizational Affiliation
Karolinska Institutet, Psychiatry Southwest, Karolinska University Hospital at Huddinge, Stockholm, e-mail: nils.lindefors@sll.se
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stockholm County Council, Psychiatry Southwest Karolinska
City
Huddinge
State/Province
Stockholm
ZIP/Postal Code
141 86
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
26284932
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.
Results Reference
derived
PubMed Identifier
22075648
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs