title: Safety, tolerability and efficacy of a rapid dose escalation of quetiapine in bipolar I mania: the FATIMA study.
abstract: OBJECTIVE
  The FATIMA study (FAst TItration of quetiapine fumarate in bipolar I MAnia) evaluated the safety, tolerability and efficacy of a rapid dose escalation of quetiapine in acutely ill bipolar I patients experiencing a manic episode.
  
  
  METHODS
  In an open-label, phase II pilot study, 29 patients aged 18 years or older, hospitalised with a bipolar I manic episode, received quetiapine twice daily for 21 days. Quetiapine was administered at 200, 400, 600, then 800 mg/day on the first 4 days, with flexible dosing (400-800 mg/day) subsequently. The primary endpoint was the proportion of patient dropouts because of adverse drug reactions during the first 7 days. Secondary safety assessments included incidences of adverse drug reactions and significant changes in vital signs. Efficacy assessments included Young Mania Rating Scale (YMRS) and Clinical Global Impressions Severity of Illness (CGI-S) score changes from day 1 to day 21.
  
  
  RESULTS
  Twenty patients (69%) completed the study. No patients withdrew as a result of drug-related adverse events (AEs) during the first 7 days. Twenty-three patients reported 58 adverse events, and most of the adverse events were mild or moderate. No clinically relevant abnormalities in vital signs were reported. Mean YMRS and CGI-S scores decreased significantly from baseline to day 21 (p < 0.001). Response and remission rates were 78 and 70%, respectively, at the end of the study.
  
  
  CONCLUSIONS
  Rapid dose escalation of quetiapine to 800 mg/day over 4 days was well tolerated and effective in reducing symptoms within 5 days in acutely ill bipolar I patients with a manic episode.
authors.affiliation: 1 Cliniques Universitaires Saint-Luc, Bruxelles, Belgium.
authors.forename: Eric
authors.initials: E
authors.lastname: Constant
authors.affiliation: 1 Cliniques Universitaires Saint-Luc, Bruxelles, Belgium.
authors.forename: Arlette
authors.initials: A
authors.lastname: Seghers
authors.affiliation: 2 Hôpital Français-César De Paepe asbl, Brussels, Belgium.
authors.forename: Enio
authors.initials: E
authors.lastname: Ranalli
authors.affiliation: 3 Centre Psychiatrie St Bernard, Manage, Belgium.
authors.forename: Vincent
authors.initials: V
authors.lastname: Ryckmans
authors.affiliation: 4 A.Z. Sint-Lucas-Sint Jozef, Assebroek, Belgium.
authors.forename: Phillippe
authors.initials: P
authors.lastname: Snauwaert
authors.affiliation: 5 Clinique Psychiatrique des Frères Alexiens, Henri-Chapelle, Belgium.
authors.forename: Marcel
authors.initials: M
authors.lastname: Parent
authors.affiliation: 6 AstraZeneca Belgium, Brussels, Belgium.
authors.forename: Guy
authors.initials: G
authors.lastname: Vandenhoven