Methylphenidate for the Treatment of Acute Mania

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Leipzig
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 24, 2014
Last verified: June 2014

February 16, 2012
June 24, 2014
March 2012
June 2015   (final data collection date for primary outcome measure)
manic symptoms as assessed by the Young Mania Rating Scale (YMRS) [ Time Frame: after 2.5 days of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01541605 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Methylphenidate for the Treatment of Acute Mania
International Randomised Double-blind Placebo-controlled Study on the Initial Treatment of Acute Mania With Methylphenidate

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Mania
  • Drug: methylphenidate
    tablets for oral use
  • Drug: Placebo
    tablets for oral use
  • Active Comparator: methylphenidate
    Intervention: Drug: methylphenidate
  • Placebo Comparator: placebo
    Intervention: Drug: Placebo
Kluge M, Hegerl U, Sander C, Dietzel J, Mergl R, Bitter I, Demyttenaere K, Gusmão R, Gonzalez-Pinto A, Perez-Sola V, Vieta E, Juckel G, Zimmermann US, Bauer M, Sienaert P, Quintão S, Edel MA, Bolyos C, Ayuso-Mateos JL, López-García P. Methylphenidate in mania project (MEMAP): study protocol of an international randomised double-blind placebo-controlled study on the initial treatment of acute mania with methylphenidate. BMC Psychiatry. 2013 Feb 27;13:71. doi: 10.1186/1471-244X-13-71.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
88
October 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Ulrich Hegerl, Prof. Dr. +49 34197 ext 24531 ulrich.hegerl@medizin.uni-leipzig.de
Contact: Michael Kluge, PD Dr. +49 34197 ext 24673 michael.kluge@medizin.uni-leipzig.de
Spain,   Belgium,   Hungary,   Germany
 
NCT01541605
MEMAP1
Yes
Michael Kluge, University of Leipzig
Michael Kluge
Spanish Clinical Research Network - CAIBER
Principal Investigator: Ulrich Hegerl, Prof. Dr. University of Leipzig
University of Leipzig
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP