Primary outcome measure
The primary outcome measure is the severity of manic symptoms as assessed by the Young Mania Rating Scale (YMRS) [41]. The YMRS is a clinician-administered mania rating scale. It has 11 items and is based on the patient’s subjective report of his or her clinical condition, normally over the previous 48 hours. In this study, the period is usually since the last scoring; at baseline and day 9 the scoring refers to the last 24 hours. Additional information is based upon clinical observations made during the course of the clinical interview. The items being scored are elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, speech (rate and amount), language-thought disorder, content, disruptive-aggressive behaviour, appearance, and insight. The purpose of each item is to rate the severity of that abnormality in the patient. A score of ≥ 12 indicates mania. The primary endpoint is after 2.5 days of treatment.