Evidence map›Paper›PMID 23446109›Full record

Trial reportBMC psychiatry2013

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.

Michael Kluge, Ulrich Hegerl, Christian Sander, Jens Dietzel, Roland Mergl, Istvan Bitter, Koen Demyttenaere, Ricardo Gusmão, Ana Gonzalez-Pinto, Victor Perez-Sola and 10 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC psychiatry, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01541605 (International Randomised Double-blind Placebo-controlled Study on the Initial Treatment of Acute Mania With Methylphenidate), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
2.1field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01541605 phase3completednot on this map

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

TypeinterventionalSponsorMichael KlugeRan2012 to 2016Enrolled42ConditionsManiaArmsmethylphenidate, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 16 citations in OpenAlex.

  1. Use of Stimulants in Bipolar Disorder.Current psychiatry reports · 2017
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 4 institutions in 4 countries.

Michael KlugeDepartment of Psychiatry and Psychotherapy, University of Leipzig, Semmelweisstrasse 10, 04103, Leipzig, Germany.
Ulrich Hegerl
Christian Sander
Jens Dietzel
Roland Mergl
Istvan Bitter
Koen Demyttenaere
Ricardo Gusmão
Ana Gonzalez-Pinto
Victor Perez-Sola
Eduard Vieta
Georg Juckel
Ulrich S Zimmermann
Michael Bauer
Pascal Sienaert
Sónia Quintão
Marc-Andreas Edel
Csilla Bolyos
Jose Luis Ayuso-Mateos
Pilar López-García
Centro de Investigación Biomédica en Red de Salud Mental · ESLeipzig University · DEKU Leuven · BESemmelweis University · HU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTreatment of patients with acute mania remains a considerable medical challenge since onset of action of antimanic medication is delayed for several days. Psychostimulants could have an earlier onset of action. This assumption is based on the 'vigilance regulation model of mania' which postulates that vigilance is unstable in manic patients. Accordingly, vigilance-stabilising psychostimulants could be more useful than conventional treatment in acute mania. We present here the study protocol of a trial intended to study the efficacy and safety of methylphenidate in the initial treatment of acute mania. METHODS/

designA multi-centre, randomised, double-blind, placebo-controlled clinical trial will be conducted in 88 bipolar inpatients with acute mania. Male and female patients older than 18 years will be randomised to treatment with either methylphenidate (20 to 40 mg/day) or placebo for 2.5 days, given once or twice daily. The main outcome measure is the reduction in the Young Mania Rating Scale (YMRS) after 2.5 days of treatment. Other outcome measures include the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) the Clinical Global Impression-Bipolar Scale (CGI-BP), the Screen for Cognitive Impairment in Psychiatry (SCIP), actigraphy and the EEG-'Vigilance Algorithm Leipzig' (VIGALL). DISCUSSION: A positive study outcome of the proposed study could substantially impact our understanding of the etiopathogenesis of mania and open new treatment perspectives.

Indexed as

Acute DiseaseAdultAntimanic AgentsBipolar DisorderDouble-Blind MethodFemaleHumansMaleMethylphenidatePsychiatric Status Rating ScalesTreatment OutcomeAntimanic AgentsMethylphenidate

Identifiers

PMID23446109
PMCPMC3598541
OpenAlexW2136537220

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.