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

Michael Kluge10 sites in 4 countries42 target enrollmentMarch 2012

ConditionsMania

Interventionsmethylphenidate Placebo

Drugsmethylphenidate Placebo

Overview

Phase: Phase 3
Intervention: methylphenidate
Conditions: Mania
Sponsor: Michael Kluge
Enrollment: 42
Locations: 10
Primary Endpoint: manic symptoms as assessed by the Young Mania Rating Scale (YMRS)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

March 2012

End Date

May 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Michael Kluge

Responsible Party

Sponsor Investigator

Principal Investigator

Michael Kluge

Senior Psychiatrist

University of Leipzig

Eligibility Criteria

Inclusion Criteria

•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.

Arms & Interventions

methylphenidate

Intervention: methylphenidate

placebo

Intervention: Placebo

Outcomes

Primary Outcomes

manic symptoms as assessed by the Young Mania Rating Scale (YMRS)

Time Frame: after 2.5 days of treatment

Secondary Outcomes

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)