Methylphenidate for the Treatment of Acute Mania

NCT ID: NCT01541605

Last Updated: 2016-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2016-05-31

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.

Conditions

Mania

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

methylphenidate

Group Type: ACTIVE_COMPARATOR

methylphenidate

Intervention Type: DRUG

tablets for oral use

placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

tablets for oral use

Interventions

methylphenidate

tablets for oral use

Intervention Type: DRUG

Placebo

tablets for oral use

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spanish Clinical Research Network - SCReN

NETWORK

Sponsor Role: collaborator

Michael Kluge

OTHER

Sponsor Role: lead

Responsible Party

Michael Kluge

Senior Psychiatrist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ulrich Hegerl, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Leipzig

Locations

Katholieke Universiteit Leuven, campus Kortenberg

Kortenberg, , Belgium

Universität Bochum

Bochum, , Germany

Universität Dresden

Dresden, , Germany

Universität Halle

Halle, , Germany

Universität Leipzig

Leipzig, , Germany

Semmelweis University

Budapest, , Hungary

Hospital Sant Pau

Barcelona, , Spain

Hospital Clinic

Barcelona, , Spain

Hospital Universitario la Princesa

Madrid, , Spain

Hospital Santiago Apóstol

Vitoria-Gasteiz, , Spain

Countries

Belgium; Germany; Hungary; Spain

References

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.

Reference Type: BACKGROUND

PMID: 23446109 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29174864 (View on PubMed)

Other Identifiers

MEMAP1

Identifier Type: -

Identifier Source: org_study_id