Methods of testing feasibility for sequenced treatment alternatives to relieve depression (STAR*D)

Stephen R. Wisniewski, Diane Stegman, Madhukar Trivedi, Mustafa M. Husain, Heather Eng, Kathy Shores-Wilson, James Luther, Melanie M. Biggs, Diane Burroughs, A. Louise Ritz, Maurizio Fava, Frederic Quitkin, A. John Rush

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

In large multi-site trials, a feasibility or pilot study can be crucial to test the functionality of all aspects of conducting the study prior to the initiation of the formal study. A feasibility trial was conducted for the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Project, a multi-site, prospective, sequentially randomized, clinical trial of outpatients with nonpsychotic major depressive disorder. From 14 December 2000 to 8 June 2001, 42 patients were screened for enrollment into the STAR*D Feasibility Trial. Twenty-four patients who were eligible and consented to participate were treated with citalopram for up to 12 weeks. During the course of this trial, issues were raised that resulted in modifications to the study procedures. Modifications made as a result of this trial affected four domains: (1) communication, (2) patient and provider burden, (3) data collection forms, and (4) recruitment and retention of subjects. This paper describes what was learned during the STAR*D Feasibility Trial so researchers planning to conduct similar trials can learn the practical issues related to conducting such a research project. While the information gathered was useful, it did delay the initiation of the formal trial. We view this cost as an investment in the development of overall study procedures that should lead to a stronger study.

Original languageEnglish (US)
Pages (from-to)241-248
Number of pages8
JournalJournal of Psychiatric Research
Volume38
Issue number3
DOIs
StatePublished - May 2004

Fingerprint

Depression
Citalopram
Major Depressive Disorder
Feasibility Studies
Outpatients
Therapeutics
Randomized Controlled Trials
Communication
Research Personnel
Costs and Cost Analysis
Research

Keywords

  • Depression
  • Feasibility
  • Functionality
  • Procedures
  • Treatment
  • Trials

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Biological Psychiatry
  • Psychology(all)

Cite this

Methods of testing feasibility for sequenced treatment alternatives to relieve depression (STAR*D). / Wisniewski, Stephen R.; Stegman, Diane; Trivedi, Madhukar; Husain, Mustafa M.; Eng, Heather; Shores-Wilson, Kathy; Luther, James; Biggs, Melanie M.; Burroughs, Diane; Ritz, A. Louise; Fava, Maurizio; Quitkin, Frederic; Rush, A. John.

In: Journal of Psychiatric Research, Vol. 38, No. 3, 05.2004, p. 241-248.

Research output: Contribution to journalArticle

Wisniewski, Stephen R. ; Stegman, Diane ; Trivedi, Madhukar ; Husain, Mustafa M. ; Eng, Heather ; Shores-Wilson, Kathy ; Luther, James ; Biggs, Melanie M. ; Burroughs, Diane ; Ritz, A. Louise ; Fava, Maurizio ; Quitkin, Frederic ; Rush, A. John. / Methods of testing feasibility for sequenced treatment alternatives to relieve depression (STAR*D). In: Journal of Psychiatric Research. 2004 ; Vol. 38, No. 3. pp. 241-248.
@article{60e3a9b961a24900bc783e9e4397f9a9,
title = "Methods of testing feasibility for sequenced treatment alternatives to relieve depression (STAR*D)",
abstract = "In large multi-site trials, a feasibility or pilot study can be crucial to test the functionality of all aspects of conducting the study prior to the initiation of the formal study. A feasibility trial was conducted for the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Project, a multi-site, prospective, sequentially randomized, clinical trial of outpatients with nonpsychotic major depressive disorder. From 14 December 2000 to 8 June 2001, 42 patients were screened for enrollment into the STAR*D Feasibility Trial. Twenty-four patients who were eligible and consented to participate were treated with citalopram for up to 12 weeks. During the course of this trial, issues were raised that resulted in modifications to the study procedures. Modifications made as a result of this trial affected four domains: (1) communication, (2) patient and provider burden, (3) data collection forms, and (4) recruitment and retention of subjects. This paper describes what was learned during the STAR*D Feasibility Trial so researchers planning to conduct similar trials can learn the practical issues related to conducting such a research project. While the information gathered was useful, it did delay the initiation of the formal trial. We view this cost as an investment in the development of overall study procedures that should lead to a stronger study.",
keywords = "Depression, Feasibility, Functionality, Procedures, Treatment, Trials",
author = "Wisniewski, {Stephen R.} and Diane Stegman and Madhukar Trivedi and Husain, {Mustafa M.} and Heather Eng and Kathy Shores-Wilson and James Luther and Biggs, {Melanie M.} and Diane Burroughs and Ritz, {A. Louise} and Maurizio Fava and Frederic Quitkin and Rush, {A. John}",
year = "2004",
month = "5",
doi = "10.1016/j.jpsychires.2003.06.001",
language = "English (US)",
volume = "38",
pages = "241--248",
journal = "Journal of Psychiatric Research",
issn = "0022-3956",
publisher = "Elsevier Limited",
number = "3",

}

TY - JOUR

T1 - Methods of testing feasibility for sequenced treatment alternatives to relieve depression (STAR*D)

AU - Wisniewski, Stephen R.

AU - Stegman, Diane

AU - Trivedi, Madhukar

AU - Husain, Mustafa M.

AU - Eng, Heather

AU - Shores-Wilson, Kathy

AU - Luther, James

AU - Biggs, Melanie M.

AU - Burroughs, Diane

AU - Ritz, A. Louise

AU - Fava, Maurizio

AU - Quitkin, Frederic

AU - Rush, A. John

PY - 2004/5

Y1 - 2004/5

N2 - In large multi-site trials, a feasibility or pilot study can be crucial to test the functionality of all aspects of conducting the study prior to the initiation of the formal study. A feasibility trial was conducted for the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Project, a multi-site, prospective, sequentially randomized, clinical trial of outpatients with nonpsychotic major depressive disorder. From 14 December 2000 to 8 June 2001, 42 patients were screened for enrollment into the STAR*D Feasibility Trial. Twenty-four patients who were eligible and consented to participate were treated with citalopram for up to 12 weeks. During the course of this trial, issues were raised that resulted in modifications to the study procedures. Modifications made as a result of this trial affected four domains: (1) communication, (2) patient and provider burden, (3) data collection forms, and (4) recruitment and retention of subjects. This paper describes what was learned during the STAR*D Feasibility Trial so researchers planning to conduct similar trials can learn the practical issues related to conducting such a research project. While the information gathered was useful, it did delay the initiation of the formal trial. We view this cost as an investment in the development of overall study procedures that should lead to a stronger study.

AB - In large multi-site trials, a feasibility or pilot study can be crucial to test the functionality of all aspects of conducting the study prior to the initiation of the formal study. A feasibility trial was conducted for the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) Project, a multi-site, prospective, sequentially randomized, clinical trial of outpatients with nonpsychotic major depressive disorder. From 14 December 2000 to 8 June 2001, 42 patients were screened for enrollment into the STAR*D Feasibility Trial. Twenty-four patients who were eligible and consented to participate were treated with citalopram for up to 12 weeks. During the course of this trial, issues were raised that resulted in modifications to the study procedures. Modifications made as a result of this trial affected four domains: (1) communication, (2) patient and provider burden, (3) data collection forms, and (4) recruitment and retention of subjects. This paper describes what was learned during the STAR*D Feasibility Trial so researchers planning to conduct similar trials can learn the practical issues related to conducting such a research project. While the information gathered was useful, it did delay the initiation of the formal trial. We view this cost as an investment in the development of overall study procedures that should lead to a stronger study.

KW - Depression

KW - Feasibility

KW - Functionality

KW - Procedures

KW - Treatment

KW - Trials

UR - http://www.scopus.com/inward/record.url?scp=10744220947&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=10744220947&partnerID=8YFLogxK

U2 - 10.1016/j.jpsychires.2003.06.001

DO - 10.1016/j.jpsychires.2003.06.001

M3 - Article

C2 - 15003429

AN - SCOPUS:10744220947

VL - 38

SP - 241

EP - 248

JO - Journal of Psychiatric Research

JF - Journal of Psychiatric Research

SN - 0022-3956

IS - 3

ER -