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Safety, tolerability and efficacy of a rapid dose escalation of quetiapine in bipolar I mania: the FATIMA study

Published online by Cambridge University Press:  24 June 2014

Eric Constant ,
Arlette Seghers ,
Enio Ranalli ,
Vincent Ryckmans ,
Phillippe Snauwaert ,
Marcel Parent  and
Guy Vandenhoven
Eric Constant*
Affiliation:
Cliniques Universitaires Saint-Luc, Bruxelles, Belgium
Arlette Seghers
Affiliation:
Cliniques Universitaires Saint-Luc, Bruxelles, Belgium
Enio Ranalli
Affiliation:
Hôpital Français—César De Paepe asbl, Brussels, Belgium
Vincent Ryckmans
Affiliation:
Centre Psychiatrie St Bernard, Manage, Belgium
Phillippe Snauwaert
Affiliation:
A.Z. Sint-Lucas—Sint Jozef, Assebroek, Belgium
Marcel Parent
Affiliation:
Clinique Psychiatrique des Frères Alexiens, Henri-Chapelle, Belgium
Guy Vandenhoven
Affiliation:
AstraZeneca Belgium, Brussels, Belgium
*
Dr Eric Constant, Service de Psychiatrie, Cliniques Universitaires Saint-Luc, Avenue Hippocrate, 10, 1200 Bruxelles, Belgium. Tel: +32 2 764 2038; Fax: +32 2 764 8921; E-mail: [email protected]
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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.

Conclusion:

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.

Keywords

bipolar maniaquetiapinerapid dose escalation
Type
Research Article
Information
Acta Neuropsychiatrica , Volume 21 , Issue 3 , June 2009 , pp. 125 - 132
Copyright
Copyright © 2009 John Wiley & Sons A/S

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