This work may not be copied, distributed, displayed, published, reproduced, transmitted, modified, posted, sold, licensed, or used for commercial purposes. By downloading this file, you are agreeing to the publisher’s Terms & Conditions.

Original Articles

The Efficacy and Safety of a New Enteric-Coated Formulation of Fluoxetine Given Once Weekly During the Continuation Treatment of Major Depressive Disorder

Mark E. Schmidt, Maurizio Fava, James M. Robinson, and Rajinder Judge

Published: October 31, 2000

Article Abstract

Background: A simple, once-weekly dosingregimen could be a convenient alternative for many patientsduring long-term treatment of depression. Such a strategy mightalso be effective for improving medication compliance and theoutcome of continuation treatment. The safety and effectivenessof a new formulation of enteric-coated fluoxetine (90 mg) givenonce weekly was tested during the continuation treatment of majordepressive disorder.

Method: Patients meeting DSM-IV criteriafor major depressive disorder with modified 17-item HamiltonRating Scale for Depression (HAM-D-17) scores >= 18and Clinical Global Impressions-Severity of Illness scale (CGI-S)scores >= 4 were treated 13 weeks with open-label 20 mg/day offluoxetine in a multicenter U.S. study. Responders (N = 501) wererandomly assigned to receive 20 mg of fluoxetine daily, placebo,or 90 mg of enteric-coated fluoxetine weekly for 25 weeks ofdouble-blind continuation treatment. The primary efficacy measurewas the percentage of patients who relapsed. Time to relapse wastested over the 25-week continuation period using log-rankanalyses of the Kaplan-Meier estimates of relapse rates.Additional analyses of efficacy included comparison of changefrom baseline to endpoint for the HAM-D-17, CGI-S, and HAM-D-28subscales by last observation carried forward (LOCF). Safetymeasures included comparison of treatment-emergent adverseevents, both spontaneous and solicited (using the Association forMethodology of Documentation in Psychiatry-Module 5), vitalsigns, and laboratory measures.

Results: Relapse rates for patientsassigned to fluoxetine, either 20 mg daily or 90 mg weekly, weresignificantly lower than for placebo by log-rank analysis andLOCF analyses of secondary efficacy measures. Efficacy did notsignificantly differ between the 2 active drug groups by thesemeasures. Enteric-coated fluoxetine at a once-weekly dose of 90mg was well tolerated, and its safety profile was similar to thatof daily 20 mg of fluoxetine.

Conclusion: The formulation ofenteric-coated fluoxetine taken once weekly is effective, safe,and well tolerated for continuation treatment of depression inpatients who responded to acute treatment with 20 mg/day offluoxetine. Monitoring during long-term treatment for evidence ofsustained remission is important regardless of dosing regimen.

Volume: 61

Quick Links: Depression (MDD)

Continue Reading…

Subscribe to read the entire article

$40.00

Buy this Article as a PDF

Sign-up to stay
up-to-date today!

SUBSCRIBE

Already registered? Sign In

Original Research

Young-Adult Social Outcomes of Attention-Deficit/Hyperactivity Disorder

ADHD that persisted into young-adulthood was associated with poorer outcomes in terms of education, employment, and emotional...

Read More...