Site variability in treatment outcome in antidepressant trials

Site variability in treatment outcome in antidepressant trials Objective: Site-specific differences in treatment outcome during multisite antidepressant drug trials may contribute to a negative or failed clinical trial. As part of a five-site, long-term, double-blind, placebo-controlled, relapse prevention trial with fluoxetine in major depression, the authors examined site-specific variability in outcome ratings. Methods: Data from 390 patients with major depression who participated in a 64-week, placebo-controlled trial were retrospectively analyzed. χ 2 Analyses and Kaplan–Meier survival estimates were used to examine site-specific differences in relapse rates during 14 weeks of maintenance treatment following randomization to fluoxetine or placebo after remission with fluoxetine treatment. Results: Results from χ 2 analysis ( P <.001) and Kaplan–Meier survival rates ( P <.001) following randomization to placebo after 12 weeks of fluoxetine treatment showed a fluoxetine superiority over placebo among all five sites combined. Individually, however, only three of the five sites (60%) were able to distinguish fluoxetine superiority. In contrast, there was no fluoxetine versus placebo difference observed among all five sites after randomization following 26 weeks of fluoxetine treatment ( P =.11, Fisher's exact test). However, one site (20%) individually could still distinguish a drug versus placebo difference ( P <.05). Limitations: Analyses were performed retrospectively, with individual sites not specifically powered to distinguish a drug–placebo difference. Conclusion: Substantial site differences were observed in the ability to distinguish drug superiority over placebo, and this variability may contribute to a negative or failed clinical drug trial. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Progress in Neuro-Psychopharmacology & Biological Psychiatry Elsevier

Site variability in treatment outcome in antidepressant trials

Loading next page...
 
/lp/elsevier/site-variability-in-treatment-outcome-in-antidepressant-trials-4brZT2IzQi
Publisher
Elsevier
Copyright
Copyright © 2002 Elsevier Science Inc.
ISSN
0278-5846
eISSN
1878-4216
DOI
10.1016/S0278-5846(02)00219-1
Publisher site
See Article on Publisher Site

Abstract

Objective: Site-specific differences in treatment outcome during multisite antidepressant drug trials may contribute to a negative or failed clinical trial. As part of a five-site, long-term, double-blind, placebo-controlled, relapse prevention trial with fluoxetine in major depression, the authors examined site-specific variability in outcome ratings. Methods: Data from 390 patients with major depression who participated in a 64-week, placebo-controlled trial were retrospectively analyzed. χ 2 Analyses and Kaplan–Meier survival estimates were used to examine site-specific differences in relapse rates during 14 weeks of maintenance treatment following randomization to fluoxetine or placebo after remission with fluoxetine treatment. Results: Results from χ 2 analysis ( P <.001) and Kaplan–Meier survival rates ( P <.001) following randomization to placebo after 12 weeks of fluoxetine treatment showed a fluoxetine superiority over placebo among all five sites combined. Individually, however, only three of the five sites (60%) were able to distinguish fluoxetine superiority. In contrast, there was no fluoxetine versus placebo difference observed among all five sites after randomization following 26 weeks of fluoxetine treatment ( P =.11, Fisher's exact test). However, one site (20%) individually could still distinguish a drug versus placebo difference ( P <.05). Limitations: Analyses were performed retrospectively, with individual sites not specifically powered to distinguish a drug–placebo difference. Conclusion: Substantial site differences were observed in the ability to distinguish drug superiority over placebo, and this variability may contribute to a negative or failed clinical drug trial.

Journal

Progress in Neuro-Psychopharmacology & Biological PsychiatryElsevier

Published: Jun 1, 2002

References

  • Site variability in a multisite geriatric depression trial
    Small, G.W.; Schneider, L.S.; Hamilton, S.H.; Bystritsky, A.; Meyers, B.S.; Nemeroff, C.B.

You’re reading a free preview. Subscribe to read the entire article.


DeepDyve is your
personal research library

It’s your single place to instantly
discover and read the research
that matters to you.

Enjoy affordable access to
over 18 million articles from more than
15,000 peer-reviewed journals.

All for just $49/month

Explore the DeepDyve Library

Search

Query the DeepDyve database, plus search all of PubMed and Google Scholar seamlessly

Organize

Save any article or search result from DeepDyve, PubMed, and Google Scholar... all in one place.

Access

Get unlimited, online access to over 18 million full-text articles from more than 15,000 scientific journals.

Your journals are on DeepDyve

Read from thousands of the leading scholarly journals from SpringerNature, Elsevier, Wiley-Blackwell, Oxford University Press and more.

All the latest content is available, no embargo periods.

See the journals in your area

DeepDyve

Freelancer

DeepDyve

Pro

Price

FREE

$49/month
$360/year

Save searches from
Google Scholar,
PubMed

Create folders to
organize your research

Export folders, citations

Read DeepDyve articles

Abstract access only

Unlimited access to over
18 million full-text articles

Print

20 pages / month

PDF Discount

20% off