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Vol. 71, No. 4, 2002
Issue release date: July–August 2002
Section title: Regular Article
Psychother Psychosom 2002;71:190–194
(DOI:10.1159/000063643)

Treatment Approaches to Major Depressive Disorder Relapse

Part 1: Dose Increase

Schmidt M.E. · Fava M. · Zhang S. · Gonzales J. · Raute N.J. · Judge R.
aLilly Research Laboratories, Indianapolis, Ind., and bDepression Clinical and Research Program, Massachusetts General Hospital, Boston, Mass., USA

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Article / Publication Details

First-Page Preview
Abstract of Regular Article

Published online: 7/1/2002

Number of Print Pages: 5
Number of Figures: 1
Number of Tables: 2

ISSN: 0033-3190 (Print)
eISSN: 1423-0348 (Online)

For additional information: http://www.karger.com/PPS

Abstract

Objective: Although continuing antidepressant treatment after patients have responded to medication has been shown to greatly reduce the risk of relapse, this risk is not eliminated. A number of theories have been proposed to account for this apparent loss of efficacy. A common initial approach to managing relapse is to increase the dose of antidepressant. We prospectively evaluated the likelihood of response to increasing the fluoxetine doses in patients relapsing during a long-term efficacy study of two fluoxetine dosing regimens. Method: Patients meeting the DSM-IV criteria for major depressive disorder with modified HAMD17 scores ≧18 and CGI-severity scores ≧4 were treated for 13 weeks with open-label 20 mg/day fluoxetine in a multicenter US study. Responders (n = 501) were randomized to 20 mg fluoxetine daily, placebo, or 90 mg enteric-coated fluoxetine weekly for 25 weeks of double-blind continuation treatment. If the patients relapsed during the continuation phase, they were offered a 25-week optional rescue treatment phase during which the study medication dose was increased as follows: (1) patients on placebo had treatment with fluoxetine 20 mg/day reinitiated, (2) patients on fluoxetine 20 mg/day had their dose increased to 40 mg/day, and (3) patients on a 90-mg weekly dose had their dose increased to 90 mg twice a week. The results of the rescue phase for the latter two groups who relapsed while on continuation treatment with fluoxetine are reported. Response was defined as a 50% reduction in the modified HAMD17 score since time of relapse and a CGI-severity score ≤2. Additional efficacy analyses included HAMD and CGI-severity changes from baseline to endpoint. Safety measures included assessment of treatment-emergent adverse events, vital signs, and laboratory measures. Results: Overall, patients relapsing during the continuation treatment responded to an increased dose (57% of the 40-mg-daily group and 72% of the enteric-coated 90-mg-twice-weekly group). Mean modified HAMD17 scores decreased from a mean of approximately 20 to below 8 and were maintained for up to 6 months in the responders. Thirty-five percent of patients either did not respond or initially responded but again relapsed after augmentation of medication. Conclusions: The patients relapsing after initially responding to fluoxetine can benefit from an increase in fluoxetine dose. These results also generally support increasing dose as a first-line treatment strategy for a patient who has relapsed while taking a previously effective dose of an antidepressant. Increasing enteric-coated fluoxetine 90 mg once weekly to twice weekly appeared to be as well-tolerated and effective in restoring response as increasing a daily fluoxetine dose from 20 to 40 mg.


  

Author Contacts

Jill Gonzales
DC 2434, Lilly Corporate Center
Indianapolis, IN 46285 (USA)
Tel. +1 317 277 9450, Fax +1 317 277 3630
E-Mail jgonzales@lilly.com

  

Article Information

This work was sponsored by Eli Lilly and Company.

Number of Print Pages : 5
Number of Figures : 1, Number of Tables : 2, Number of References : 18

  

Publication Details

Psychotherapy and Psychosomatics
Founded 1953 as ‘Acta Psychotherapeutica et Psychosomatica’ by E.A.D.E. Carp and B. Stokvis, continued by Th. Spoerri (1964–1974) and P.E. Sifneos (1974–1991)

Vol. 71, No. 4, Year 2002 (Cover Date: July-August 2002)

Journal Editor: G.A. Fava, Bologna
ISSN: 0033–3190 (print), 1423–0348 (Online)

For additional information: http://www.karger.com/journals/pps


Article / Publication Details

First-Page Preview
Abstract of Regular Article

Published online: 7/1/2002

Number of Print Pages: 5
Number of Figures: 1
Number of Tables: 2

ISSN: 0033-3190 (Print)
eISSN: 1423-0348 (Online)

For additional information: http://www.karger.com/PPS


Copyright / Drug Dosage

Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher or, in the case of photocopying, direct payment of a specified fee to the Copyright Clearance Center.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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