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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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References

American Psychiatric Association. Practice Guideline for the Treatment of Patients with Bipolar Disorder (2nd edn). Available at http://www.psych.org/psych_pract/treatg/pg/bipolar_revisebook_index.cfm, 2002. Google Scholar
Goldberg, JF, Garno, JL, Leon, AC, Kocsis, JH, Portera, L.Rapid titration of mood stabilizers predicts remission from mixed or pure mania in bipolar patients. J Clin Psychiatry 1998;59: 151–158. CrossRefGoogle ScholarPubMed
Oluboka, OJ, Bird, DC, Kutcher, S, Kusukumar, V.A pilot study of loading versus titration of valproate in the treatment of acute mania. Bipolar Disord 2002;4: 341–345. CrossRefGoogle ScholarPubMed
Hirschfeld, RM, Allen, MH, McEvoy, JP, Keck, PE Jr, Russell, JM.Safety and tolerability of oral loading divalproex sodium in acutely manic bipolar patients. J Clin Psychiatry 1999;60: 815–818. CrossRefGoogle ScholarPubMed
Baker, RW, Kinon, BJ, Maguire, GA, Liu, H, Hill, AL.Effectiveness of rapid initial dose administration of up to forty milligrams per day of oral olanzapine in acute agitation. J Clin Psychopharmacol 2003;23: 342–348. CrossRefGoogle ScholarPubMed
Keck, PE Jr, McElroy, SL, Bennett, JA.Pharmacologic loading in the treatment of acute mania. Bipolar Disord 2000;2: 42–46. CrossRefGoogle ScholarPubMed
Hatim, A, Habil, H, Jesjeet, SGet al. Safety and efficacy of rapid dose administration of quetiapine in bipolar mania. Hum Psychopharmacol 2006;21: 313–318. CrossRefGoogle ScholarPubMed
Pae, CU, Nassir Ghaemi, SN, Kim, TSet al. Rapid titration versus conventional titration of quetiapine in the treatment of bipolar mania: a preliminary trial. Int Clin Psychopharmacol 2005;20: 327–330. CrossRefGoogle ScholarPubMed
Pajonk, FG, Schwertner, AK, Seelig, MA.Rapid dose titration of quetiapine for the treatment of acute schizophrenia and acute mania: a case series. J Psychopharmacol 2006;20: 119–124. CrossRefGoogle ScholarPubMed
Bowden, CL, Grunze, H, Mullen, Jet al. A randomized, double-blind, placebo-controlled efficacy and safety study of quetiapine or lithium as monotherapy for mania in bipolar disorder. J Clin Psychiatry 2005;66: 111–121. CrossRefGoogle ScholarPubMed
Yatham, LN, Paulsson, B, Mullen, J, Vågerö, M.Quetiapine versus placebo in combination with lithium or divalproex for the treatment of bipolar mania. J Clin Psychopharmacol 2004;24: 599–606. CrossRefGoogle ScholarPubMed
McIntyre, R, Brecher, M, Paulsson, B.Quetiapine or haloperidol as monotherapy for bipolar mania—a 12-week, double-blind, randomised, parallel-group, placebo-controlled trial. Eur Neuropsychopharmacol 2005;15: 573–585. CrossRefGoogle ScholarPubMed
Sachs, G, Chengappa, KN, Suppes, Tet al. Quetiapine with lithium or divalproex for the treatment of bipolar mania: a randomized, double-blind, placebo-controlled study. Bipolar Disord 2004;6: 213–223. CrossRefGoogle ScholarPubMed
Vieta, E, Mullen, J, Brecher, M, Paulsson, B, Jones, M.Quetiapine monotherapy for mania associated with bipolar disorder: analysis of two international, double-blind, randomised, placebo-controlled studies. Curr Med Res Opin 2005;21: 923–934. CrossRefGoogle ScholarPubMed
Calabrese, JR, Keck, PE Jr, Macfadden, Wet al. A randomized, double-blind, placebo-controlled trial of quetiapine in the treatment of bipolar I or II depression. Am J Psychiatry 2005;162: 1351–1360. CrossRefGoogle ScholarPubMed
Thase, ME, Macfadden, W, Weisler, RH, Chang, W, Paulsson, B, Khan, A; for The BOLDER II Study Group. Efficacy of quetiapine monotherapy in bipolar I and II depression: a double-blind, placebo-controlled study (the BOLDER II study). J Clin Psychopharmacol 2006;26: 600–609. CrossRefGoogle Scholar
Smith, MA, McCoy, R, Hamer-Maansson, J, Brecher, M.Rapid dose escalation with quetiapine: a pilot study. J Clin Psychopharmacol 2005;25: 331–335. CrossRefGoogle ScholarPubMed
Pae, CU, Kim, JJet al. Rapid versus conventional initiation of quetiapine in the treatment of schizophrenia: A randomized, parallel-group trial. J Clin Psychiatry 2007;68: 399–405. CrossRefGoogle ScholarPubMed
Boidi, G, Ferro, M..Rapid dose initiation of quetiapine for the treatment of acute schizophrenia and schizoaffective disorder: a randomised, multicentre, parallel-group, open study. Hum Psychopharmacol 2007;22: 299–306. CrossRefGoogle ScholarPubMed
Vieta, E, Goldberg, JF, Mullen, J, Vågerö, M, Paulsson, B.Quetiapine in the treatment of acute mania: target dose for efficacious treatment. J Affect Disord 2007;100(suppl. 1) 23–31. CrossRefGoogle ScholarPubMed