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).DiscussionA positive study outcome of the proposed study could substantially impact our understanding of the etiopathogenesis of mania and open new treatment perspectives.Trial registrationClinicalTrials.gov: NCT 01541605
Highlights
Treatment of patients with acute mania remains a considerable medical challenge since onset of action of antimanic medication is delayed for several days
A positive study outcome of the proposed study could substantially impact our understanding of the etiopathogenesis of mania and open new treatment perspectives
It takes into account that the vigilance level –vigilance defined as brain arousal– does influence behaviour but that in turn, behaviour can affect the level of vigilance; i.e. a more/less stimulating environment can be actively created in order to increase/reduce vigilance levels
Summary
Treatment 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. While above mentioned substances are sedating, we intend to use a rapidly acting, stimulating substance in this study This plan is based on the ‘vigilance regulation model of mania’. Overtired children often develop a hyperactive, talkative and sensation seeking behaviour which can be interpreted as an autoregulatory attempt to stabilise vigilance by increasing external stimulation. We postulate that this physiological autoregulatory mechanism may result in a pathological behavioural syndrome, namely mania, in vulnerable subjects [4,5,6]. The autoregulatory mechanism might override the physiological tendency to seek sleep, aggravating sleep deficits, worsening vigilance instability and thereby starting a vicious circle ending up in full-blown mania (Figure 1) [4]
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