PMC:3598541 / 12703-16032 JSONTXT

{"target":"https://pubannotation.org/docs/sourcedb/PMC/sourceid/3598541","sourcedb":"PMC","sourceid":"3598541","source_url":"http://www.ncbi.nlm.nih.gov/pmc/3598541","text":"Study population\nThe study population will comprise 88 adults of either sex with the diagnosis of a manic episode according to ICD-10, 44 in each arm of the study. To be included in the study, patients must fulfil all inclusion criteria and not meet an exclusion criterion.\nInclusion criteria are: 1. inpatients; 2. written informed consent by patients who are competent to consent to study participation; 3. diagnosis of a manic episode according to ICD-10 classification (F30.0, F30.1, F31.0 or F31.1); 4. male or female ≥ 18 years of age; 5. YMRS total score ≥ 20 and ≤ 45 points; 6. body mass index (BMI) \u003e 17 and 7. patients must be able to swallow tablets (study drug).\nExclusion criteria are: 1. any other current major psychiatric ICD-10 disorder except for attention deficit hyperactivity disorder (ADHD) or other hyperkinetic disorders (F90), harmful use of tobacco (F17.1), dependence syndrome of tobacco (F17.2), neurotic, stress-related and somatoform disorders (F40-48), behavioural syndromes associated with physiological disturbances and physical factors (F50-F59) or disorders of adult personality and behaviour (F60-F69); 2. contraindications for treatment with methylphenidate except as noted otherwise including hypersensitivity to methylphenidate or components of the drug, patients with extreme anxiety and agitation, women with child bearing potency without effective contraception (i. e. implants, injectables, combined oral contraceptives, some IUDs or vasectomised partner) during the conduct of the trial. Patients using hormonal methods of contraception must be informed about possible influences of the study drug on contraception; 3. serious non-psychiatric disease (e.g. infectious, autoimmune or metabolic), that may interfere with the objectives of the study or with the safety or compliance of the subject, as judged by the investigator; 4. oral administration of MAO-inhibitors within two weeks, fluoxetine within 6 weeks and of any other antidepressant or primarily psychotropic substance except for those specified below within one week before study entry; 5. stable treatment with mood stabilisers including lithium, anticonvulsants (e.g. valproate, carbamazepine) or antipsychotics (e.g. risperidone, olanzapine) or benzodiazepines is NOT an exclusion criterion and will be continued; however, patients receiving more than 2 of these substances are NOT eligible for inclusion; 6. medical history of other disorders of CNS including tics or dyskinesia; 7. medical history of cardiovascular diseases, severe hypertension, glaucoma, hyperfunction of the thyroid; 8. patients with congenital or acquired long QT syndrome, or with a familiy history of QT prolongation, sudden cardiac death or other significant inherited cardiac disorders (e.g. family history of hypertrophic cardiomyopathy); 9. history of Electroconvulsive therapy within the last 3 month; 10. known alcohol and drug addiction or abuse, except for patients with abstinence \u003e 3 month. Patients with sporadic abuse of cannabis (products) will not be excluded from the study. That is even true with a positive THC screen in urine; 11. pregnant or nursing women; 12. concomitant participation in other clinical trials or participation during the 30 days prior to screening; 13. prior participation in this study or 14. 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