Methylphenidate for the Treatment of Acute Mania

NCT01541605 | Completed Phase 3 DMC

• 1 other identifier: MEMAP1
• Study Type: interventional
• Target: 42
• Locations: 4 countries
• Sites: 10

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.

Conditions

Mania

Outcome Measures

Primary Outcomes (1)

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

  after 2.5 days of treatment

Secondary Outcomes (3)

• EEG-vigilance as assessed by the Vigilanz Algorhithm Leipzig (VIGALL)

  after 2.5 days of treatment

• movements as assessed by actimetry

  after 2.5 days of treatment

• cognitive performance as assesd with the Screen for Cognitive Impairment in Psychiatry (SCIP)

  after 2.5 days of treatment

Study Arms (2)

methylphenidate

ACTIVE COMPARATOR

Drug: methylphenidate

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

methylphenidate DRUG

tablets for oral use

methylphenidate

Placebo DRUG

tablets for oral use

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Michael Kluge: lead
• Spanish Clinical Research Network - SCReN: collaborator

Study Sites (10)

Katholieke Universiteit Leuven, campus Kortenberg

Kortenberg, 3070, Belgium

Location

Universität Bochum

Bochum, 44791, Germany

Location

Universität Dresden

Dresden, 01307, Germany

Location

Universität Halle

Halle, Germany

Location

Universität Leipzig

Leipzig, Germany

Location

Semmelweis University

Budapest, 1083, Hungary

Location

Hospital Sant Pau

Barcelona, 8025, Spain

Location

Hospital Clinic

Barcelona, 8036, Spain

Location

Hospital Universitario la Princesa

Madrid, 28006, Spain

Location

Hospital Santiago Apóstol

Vitoria-Gasteiz, 01004, Spain

Location

Related Publications (2)

• 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.

  PMID: 23446109 BACKGROUND

• 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.

  PMID: 29174864 DERIVED

MeSH Terms

Conditions

Mania

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ulrich Hegerl, Prof. Dr.

  University of Leipzig

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Psychiatrist

Study Record Dates

• First Submitted: February 16, 2012
• First Posted: March 1, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 10, 2016

Record last verified: 2016-06

Locations

HU (1); BE (1); ES (4); DE (4)