

The Santiago Apóstol Hospital, in Vitoria, one of the sites of the Alava University Hospital (HUA - Hospital Universitario de Alava), is participating in a European clinical trial called MEMAP. This trial researches the treatment for acute mania in bipolar disorder with methylphenidate, a psychostimulant drug that could control symptoms early on.
Bipolar disorder is a mood disorder affecting approximately 1.6% of the population and is characterised for the alternating appearance of manic and depressive episodes. During the manic phase, patients present an elevated pathology in their mood, showing irritability, behaviour alterations and, often, lack of awareness of their own disease, which renders appropriate treatment difficult.
Mania is usually treated with sedating drugs and are effective after several days of treatment. However, some evidences suggest that a type of drugs with psychostimulant effects acts quicker in the control of maniac symptoms, without producing sedation. Which shows the need to demonstrate its effectiveness in this clinical trial. The trial is based on a new mania physiopathological model that proposes the existence of a unstable regulation of vigilance in patients during the manic phase of a bipolar disorder, which results in a vigilance stabilisation syndrome. According to this model, it would be more appropriate to treat manic symptoms using psychostimulants instead of sedatives.
The primary goal of this study is to prove the hypothesis that methylphenidate shows a significantly better treatment in manic symptoms than placebo after 2.5 days of treatment.
The study includes 7 centres in five countries (Germany, Belgium, Hungary, Portugal and Spain) that, in total, provide 100 patients. The Spanish participation, providing 25 patients to the study, is coordinated by CAIBER the Spanish Platform for Clinical Trials, which includes the Princesa University Hospital (Madrid), Hospital Clinic i Provincial (Barcelona) and Sant Pau (Barcelona), in addition to the Santiago Apóstol Hospital (Vitoria). The latter contributes to this study through the Mental Health Research Unit, headed by Mrs. Ana González Pinto, including five patients committed in the manic phase of the disorder.