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Methylphenidate for the Treatment of Acute Mania

Primary Purpose

Mania

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
methylphenidate
Placebo
Sponsored by
Michael Kluge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mania

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Katholieke Universiteit Leuven, campus Kortenberg
  • Universität Bochum
  • Universität Dresden
  • Universität Halle
  • Universität Leipzig
  • Semmelweis University
  • Hospital Sant Pau
  • Hospital Clinic
  • Hospital Universitario la Princesa
  • Hospital Santiago Apóstol

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

methylphenidate

placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

EEG-vigilance as assessed by the Vigilanz Algorhithm Leipzig (VIGALL)
movements as assessed by actimetry
cognitive performance as assesd with the Screen for Cognitive Impairment in Psychiatry (SCIP)

Full Information

First Posted
February 16, 2012
Last Updated
June 9, 2016
Sponsor
Michael Kluge
Collaborators
Spanish Clinical Research Network - SCReN
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1. Study Identification

Unique Protocol Identification Number
NCT01541605
Brief Title
Methylphenidate for the Treatment of Acute Mania
Official Title
International Randomised Double-blind Placebo-controlled Study on the Initial Treatment of Acute Mania With Methylphenidate
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael Kluge
Collaborators
Spanish Clinical Research Network - SCReN

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mania

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
methylphenidate
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
methylphenidate
Intervention Description
tablets for oral use
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
tablets for oral use
Primary Outcome Measure Information:
Title
manic symptoms as assessed by the Young Mania Rating Scale (YMRS)
Time Frame
after 2.5 days of treatment
Secondary Outcome Measure Information:
Title
EEG-vigilance as assessed by the Vigilanz Algorhithm Leipzig (VIGALL)
Time Frame
after 2.5 days of treatment
Title
movements as assessed by actimetry
Time Frame
after 2.5 days of treatment
Title
cognitive performance as assesd with the Screen for Cognitive Impairment in Psychiatry (SCIP)
Time Frame
after 2.5 days of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inpatients 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. Pregnant or nursing woman Concomitant participation in other clinical trials or participation during the 30 days prior to screening Prior participation in this study Suicidality
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrich Hegerl, Prof. Dr.
Organizational Affiliation
University of Leipzig
Official's Role
Principal Investigator
Facility Information:
Facility Name
Katholieke Universiteit Leuven, campus Kortenberg
City
Kortenberg
ZIP/Postal Code
3070
Country
Belgium
Facility Name
Universität Bochum
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Universität Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universität Halle
City
Halle
Country
Germany
Facility Name
Universität Leipzig
City
Leipzig
Country
Germany
Facility Name
Semmelweis University
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Hospital Sant Pau
City
Barcelona
ZIP/Postal Code
8025
Country
Spain
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
Hospital Universitario la Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Santiago Apóstol
City
Vitoria
ZIP/Postal Code
01004
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
23446109
Citation
Kluge M, Hegerl U, Sander C, Dietzel J, Mergl R, Bitter I, Demyttenaere K, Gusmao R, Gonzalez-Pinto A, Perez-Sola V, Vieta E, Juckel G, Zimmermann US, Bauer M, Sienaert P, Quintao S, Edel MA, Bolyos C, Ayuso-Mateos JL, Lopez-Garcia 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.
Results Reference
background
PubMed Identifier
29174864
Citation
Hegerl U, Mergl R, Sander C, Dietzel J, Bitter I, Demyttenaere K, Gusmao R, Gonzalez-Pinto A, Zorrilla I, Alocen AG, Sola VP, Vieta E, Juckel G, Zimmermann US, Bauer M, Sienaert P, Quintao S, Edel MA, Bolyos C, Ayuso-Mateos JL, Lopez-Garcia P, Kluge M. A multi-centre, randomised, double-blind, placebo-controlled clinical trial of methylphenidate in the initial treatment of acute mania (MEMAP study). Eur Neuropsychopharmacol. 2018 Jan;28(1):185-194. doi: 10.1016/j.euroneuro.2017.11.003. Epub 2017 Nov 23.
Results Reference
derived

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Methylphenidate for the Treatment of Acute Mania

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