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| Name | Class |
|---|---|
| Ministry of Health and Social Affairs, Sweden | OTHER_GOV |
| Region Stockholm | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Sugar pill | Placebo Comparator | Placebo given orally once daily for 5 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nils Lindefors, MD, PhD | Karolinska Institutet, Psychiatry Southwest, Karolinska University Hospital at Huddinge, Stockholm, e-mail: nils.lindefors@sll.se | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stockholm County Council, Psychiatry Southwest Karolinska | Huddinge | Stockholm County | 141 86 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26284932 | Derived | 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. | |
| 22075648 | Derived |
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|
| Placebo | Drug | Sugar pill |
|
| 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. | Blood chemistry included counting of red blood cells, white blood cells, blood platelets, and liver enzymes (ALAT, ASAT). | 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 |
| 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. |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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