Clincosm LogoSign in Get a demo

Methylphenidate for the Treatment of Acute Mania

Sponsor
Michael Kluge (Other)
Overall Status
Completed
CT.gov ID
NCT01541605
Collaborator
Spanish Clinical Research Network - SCReN (Other)
42
Enrollment
10
Locations
2
Arms
50
Duration (Months)
4.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
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 Design

Study Type:
Interventional
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 :
Mar 1, 2012
Actual Primary Completion Date :
May 1, 2016
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: methylphenidate

Drug: methylphenidate
tablets for oral use
Placebo Comparator: placebo

Drug: Placebo
tablets for oral use

Outcome Measures

Primary Outcome Measures

  1. manic symptoms as assessed by the Young Mania Rating Scale (YMRS) [after 2.5 days of treatment]

Secondary Outcome Measures

  1. EEG-vigilance as assessed by the Vigilanz Algorhithm Leipzig (VIGALL) [after 2.5 days of treatment]

  2. movements as assessed by actimetry [after 2.5 days of treatment]

  3. cognitive performance as assesd with the Screen for Cognitive Impairment in Psychiatry (SCIP) [after 2.5 days of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Katholieke Universiteit Leuven, campus Kortenberg Kortenberg Belgium 3070
2 Universität Bochum Bochum Germany 44791
3 Universität Dresden Dresden Germany 01307
4 Universität Halle Halle Germany
5 Universität Leipzig Leipzig Germany
6 Semmelweis University Budapest Hungary 1083
7 Hospital Sant Pau Barcelona Spain 8025
8 Hospital Clinic Barcelona Spain 8036
9 Hospital Universitario la Princesa Madrid Spain 28006
10 Hospital Santiago Apóstol Vitoria Spain 01004

Sponsors and Collaborators

  • Michael Kluge
  • Spanish Clinical Research Network - SCReN

Investigators

  • Principal Investigator: Ulrich Hegerl, Prof. Dr., University of Leipzig

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Michael Kluge, Senior Psychiatrist, University of Leipzig
ClinicalTrials.gov Identifier:
NCT01541605
Other Study ID Numbers:
  • MEMAP1
First Posted:
Mar 1, 2012
Last Update Posted:
Jun 10, 2016
Last Verified:
Jun 1, 2016
Additional relevant MeSH terms:
Mania
Methylphenidate

Study Results

No Results Posted as of Jun 10, 2016