PMID- 26953750
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20160310
LR  - 20160309
IS  - 0924-2708 (Print)
IS  - 0924-2708 (Linking)
VI  - 21
IP  - 3
DP  - 2009 Jun
TI  - Safety, tolerability and efficacy of a rapid dose escalation of quetiapine in 
      bipolar I mania: the FATIMA study.
PG  - 125-32
LID - 10.1111/j.1601-5215.2009.00378.x [doi]
AB  - 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.
FAU - Constant, Eric
AU  - Constant E
AD  - 1 Cliniques Universitaires Saint-Luc, Bruxelles, Belgium.
FAU - Seghers, Arlette
AU  - Seghers A
AD  - 1 Cliniques Universitaires Saint-Luc, Bruxelles, Belgium.
FAU - Ranalli, Enio
AU  - Ranalli E
AD  - 2 Hopital Francais-Cesar De Paepe asbl, Brussels, Belgium.
FAU - Ryckmans, Vincent
AU  - Ryckmans V
AD  - 3 Centre Psychiatrie St Bernard, Manage, Belgium.
FAU - Snauwaert, Phillippe
AU  - Snauwaert P
AD  - 4 A.Z. Sint-Lucas-Sint Jozef, Assebroek, Belgium.
FAU - Parent, Marcel
AU  - Parent M
AD  - 5 Clinique Psychiatrique des Freres Alexiens, Henri-Chapelle, Belgium.
FAU - Vandenhoven, Guy
AU  - Vandenhoven G
AD  - 6 AstraZeneca Belgium, Brussels, Belgium.
LA  - eng
PT  - Journal Article
PL  - England
TA  - Acta Neuropsychiatr
JT  - Acta neuropsychiatrica
JID - 9612501
EDAT- 2009/06/01 00:00
MHDA- 2009/06/01 00:01
CRDT- 2016/03/09 06:00
PHST- 2016/03/09 06:00 [entrez]
PHST- 2009/06/01 00:00 [pubmed]
PHST- 2009/06/01 00:01 [medline]
AID - S0924270800001083 [pii]
AID - 10.1111/j.1601-5215.2009.00378.x [doi]
PST - ppublish
SO  - Acta Neuropsychiatr. 2009 Jun;21(3):125-32. doi: 
      10.1111/j.1601-5215.2009.00378.x.