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Methylphenidate for the Treatment of Acute Mania

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ClinicalTrials.gov Identifier: NCT01541605
Recruitment Status : Completed
First Posted : March 1, 2012
Last Update Posted : June 10, 2016
Sponsor:
Collaborator:
Spanish Clinical Research Network - CAIBER
Information provided by (Responsible Party):
Michael Kluge, University of Leipzig

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.

Condition or disease Intervention/treatment Phase
Mania Drug: methylphenidate Drug: Placebo Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: International Randomised Double-blind Placebo-controlled Study on the Initial Treatment of Acute Mania With Methylphenidate
Study Start Date : March 2012
Primary Completion Date : May 2016
Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: methylphenidate Drug: methylphenidate
tablets for oral use
Placebo Comparator: placebo Drug: Placebo
tablets for oral use



Primary Outcome Measures :
  1. manic symptoms as assessed by the Young Mania Rating Scale (YMRS) [ Time Frame: after 2.5 days of treatment ]

Secondary Outcome Measures :
  1. EEG-vigilance as assessed by the Vigilanz Algorhithm Leipzig (VIGALL) [ Time Frame: after 2.5 days of treatment ]
  2. movements as assessed by actimetry [ Time Frame: after 2.5 days of treatment ]
  3. cognitive performance as assesd with the Screen for Cognitive Impairment in Psychiatry (SCIP) [ Time Frame: after 2.5 days of treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Inpatients
  2. Written informed consent by patients who are competent to consent to study participation.
  3. Diagnosis: manic episode according to the International Classification of Diseases 10th Revision (ICD-10): F30.0, F30.1, F31.0 or F31.1
  4. Male or female of at least 18 years of age
  5. YMRS total score ≥ 20 and ≤ 45 points
  6. Body mass index (BMI) > 17
  7. Patients must be able to swallow tablets (study drug).

Exclusion Criteria:

  1. 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
  2. Contraindications for treatment with methylphenidate except as noted otherwise
  3. 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
  4. 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.
  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 > 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.
  11. Pregnant or nursing woman
  12. Concomitant participation in other clinical trials or participation during the 30 days prior to screening
  13. Prior participation in this study
  14. Suicidality

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01541605


Locations
Belgium
Katholieke Universiteit Leuven, campus Kortenberg
Kortenberg, Belgium, 3070
Germany
Universität Bochum
Bochum, Germany, 44791
Universität Dresden
Dresden, Germany, 01307
Universität Halle
Halle, Germany
Universität Leipzig
Leipzig, Germany
Hungary
Semmelweis University
Budapest, Hungary, 1083
Spain
Hospital Sant Pau
Barcelona, Spain, 8025
Hospital Clinic
Barcelona, Spain, 8036
Hospital Universitario la Princesa
Madrid, Spain, 28006
Hospital Santiago Apóstol
Vitoria, Spain, 01004
Sponsors and Collaborators
Michael Kluge
Spanish Clinical Research Network - CAIBER
Investigators
Principal Investigator: Ulrich Hegerl, Prof. Dr. University of Leipzig

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Kluge, Senior Psychiatrist, University of Leipzig
ClinicalTrials.gov Identifier: NCT01541605     History of Changes
Other Study ID Numbers: MEMAP1
First Posted: March 1, 2012    Key Record Dates
Last Update Posted: June 10, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents