Methylphenidate for the Treatment of Acute Mania

Study Overview
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Brief Summary
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This study aims at evaluating the efficacy and safety of methylphenidate in the initial treatment of acute mania in patients with bipolar affective disorders.

Detailed Description
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Mania can be regarded as an autoregulatory mechanism to enhance unstable vigilance. There is increasing evidence that psychostimulants that increase vigilance may be effective in treating mania. However, controlled studies are lacking. This is a two-arm, randomised, placebo-controlled, double-blind, parallel, multi-centre phase IIIb exploratory study to evaluate the efficacy and safety of methylphenidate in the initial treatment of acute mania in patients with bipolar affective disorders.

Official Title
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International Randomised Double-blind Placebo-controlled Study on the Initial Treatment of Acute Mania With Methylphenidate

Conditions
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Mania

Intervention / Treatment
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* Drug: methylphenidate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inpatients Written informed consent by patients who are competent to consent to study participation. Diagnosis: manic episode according to the International Classification of Diseases 10th Revision (ICD-10): F30.0, F30.1, F31.0 or F31.1 Male or female of at least 18 years of age YMRS total score ≥ 20 and ≤ 45 points Body mass index (BMI) > 17 Patients must be able to swallow tablets (study drug). Exclusion Criteria: Any other current major psychiatric ICD-10 disorder is an exclusion criterion except for the following F90, F17.1, F17.2, F40-F59, F60-F69 Contraindications for treatment with methylphenidate except as noted otherwise Serious non-psychiatric disease, that may interfere with the objectives of the study or with the safety or compliance of the subject, as judged by the investigator Oral administration of monoaminooxidase (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. 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 Medical history of other disorders of CNS including tics or dyskinesia Medical history of cardiovascular diseases, severe hypertension, glaucoma, hyperfunction of the thyroid 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). History of Electroconvulsive therapy within the last 3 month Known alcohol and drug addiction or abuse, except for patients with abstinence > 3 month. Patients with sporadic abuse of cannabis (products) will not be excluded from the study. That is even true with a positive Tetrahydrocannabinol (THC) screen in urine. Pregnant or nursing woman Concomitant participation in other clinical trials or participation during the 30 days prior to screening Prior participation in this study Suicidality

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: methylphenidate<br> | Drug: methylphenidate<br>* tablets for oral use<br>|
| Placebo Comparator: placebo<br> | Drug: Placebo<br>* tablets for oral use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| manic symptoms as assessed by the Young Mania Rating Scale (YMRS) |  | after 2.5 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG-vigilance as assessed by the Vigilanz Algorhithm Leipzig (VIGALL) |  | after 2.5 days of treatment | 
| movements as assessed by actimetry |  | after 2.5 days of treatment | 
| cognitive performance as assesd with the Screen for Cognitive Impairment in Psychiatry (SCIP) |  | after 2.5 days of treatment |