Methylphenidate for the Treatment of Acute Mania

Mania Clinical Trial

Official title:

International Randomised Double-blind Placebo-controlled Study on the Initial Treatment of Acute Mania With Methylphenidate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01541605
• Other study ID #: MEMAP1
• Status: Completed
• Phase: Phase 3
• First received: February 16, 2012
• Last updated: June 9, 2016
• Start date: March 2012
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mania

Intervention

Drug:
• methylphenidate
tablets for oral use
• Placebo
tablets for oral use

Locations

Country	Name	City	State
Belgium	Katholieke Universiteit Leuven, campus Kortenberg	Kortenberg
Germany	Universität Bochum	Bochum
Germany	Universität Dresden	Dresden
Germany	Universität Halle	Halle
Germany	Universität Leipzig	Leipzig
Hungary	Semmelweis University	Budapest
Spain	Hospital Clinic	Barcelona
Spain	Hospital Sant Pau	Barcelona
Spain	Hospital Universitario la Princesa	Madrid
Spain	Hospital Santiago Apóstol	Vitoria

Sponsors (2)

Lead Sponsor	Collaborator
Michael Kluge	Spanish Clinical Research Network - CAIBER

Countries where clinical trial is conducted

Belgium,  Germany,  Hungary,  Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	manic symptoms as assessed by the Young Mania Rating Scale (YMRS)		after 2.5 days of treatment	No
Secondary	EEG-vigilance as assessed by the Vigilanz Algorhithm Leipzig (VIGALL)		after 2.5 days of treatment	No
Secondary	movements as assessed by actimetry		after 2.5 days of treatment	No
Secondary	cognitive performance as assesd with the Screen for Cognitive Impairment in Psychiatry (SCIP)		after 2.5 days of treatment	No