Methylphenidate for the Treatment of Acute Mania

This study has been completed.
Sponsor:
Collaborator:
Spanish Clinical Research Network - CAIBER
Information provided by (Responsible Party):
Michael Kluge, University of Leipzig
ClinicalTrials.gov Identifier:
NCT01541605
First received: February 16, 2012
Last updated: June 9, 2016
Last verified: June 2016
  Purpose
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 Intervention Phase
Mania
Drug: methylphenidate
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: International Randomised Double-blind Placebo-controlled Study on the Initial Treatment of Acute Mania With Methylphenidate

Resource links provided by NLM:


Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • manic symptoms as assessed by the Young Mania Rating Scale (YMRS) [ Time Frame: after 2.5 days of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • EEG-vigilance as assessed by the Vigilanz Algorhithm Leipzig (VIGALL) [ Time Frame: after 2.5 days of treatment ] [ Designated as safety issue: No ]
  • movements as assessed by actimetry [ Time Frame: after 2.5 days of treatment ] [ Designated as safety issue: No ]
  • cognitive performance as assesd with the Screen for Cognitive Impairment in Psychiatry (SCIP) [ Time Frame: after 2.5 days of treatment ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: March 2012
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: methylphenidate Drug: methylphenidate
tablets for oral use
Placebo Comparator: placebo Drug: Placebo
tablets for oral use

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Michael Kluge, Senior Psychiatrist, University of Leipzig
ClinicalTrials.gov Identifier: NCT01541605     History of Changes
Other Study ID Numbers: MEMAP1 
Study First Received: February 16, 2012
Last Updated: June 9, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on July 24, 2016