A randomized controlled trial of venlafaxine XR for major depressive disorder after spinal cord injury: Methods and lessons learned

Charles H. Bombardier*, Jesse R. Fann, Catherine S. Wilson, Allen W. Heinemann, J. Scott Richards, Ann Marie Warren, Larry Brooks, Catherine A. Warms, Nancy R. Temkin, Denise G. Tate

*Corresponding author for this work

Research output: Contribution to journalReview article

11 Citations (Scopus)

Abstract

Context/objective: We describe the rationale, design, methods, and lessons learned conducting a treatment trial for major depressive disorder (MDD) or dysthymia in people with spinal cord injury (SCI). Design: A multi-site, double-blind, randomized (1:1) placebo controlled trial of venlafaxine XR for MDD or dysthymia. Subjects were block randomized and stratified by site, lifetime history of substance dependence, and prior history of MDD. Setting: Six SCI centers throughout the United States. Participants: Across participating centers, 2536 subjects were screened and 133 were enrolled into the trial. Subjects were 18-64 years old and at least 1 month post-SCI. Interventions: Twelve-week trial of venlafaxine XR versus placebo using a flexible titration schedule. Outcome measures: The primary outcome was improvement in depression severity at 12 weeks. The secondary outcome was improvement in pain. Results: This article includes study methods, modifications prompted by a formative review process, preliminary data on the study sample and lessons learned. We describe common methodological and operational challenges conducting multi-site trials and how we addressed them. Challenges included study organization and decision making, staff training, obtaining human subjects approval, standardization of measurement and treatment, data and safety monitoring, subject screening and recruitment, unblinding and continuity of care, database management, and data analysis. Conclusions: The methodological and operational challenges we faced and the lessons we learned may provide useful information for researchers who aim to conduct clinical trials, especially in the area of medical treatment of depression in people with SCI.

Original languageEnglish (US)
Pages (from-to)247-263
Number of pages17
JournalJournal of Spinal Cord Medicine
Volume37
Issue number3
DOIs
StatePublished - May 2014

Fingerprint

Major Depressive Disorder
Spinal Cord Injuries
Randomized Controlled Trials
Placebos
Depression
Continuity of Patient Care
Substance-Related Disorders
Decision Making
Appointments and Schedules
Therapeutics
Research Personnel
Outcome Assessment (Health Care)
Clinical Trials
Databases
Safety
Pain
Venlafaxine Hydrochloride

Keywords

  • Antidepressants
  • Dysthymia
  • Major depressive disorder
  • Pain
  • Randomized controlled trials
  • Research design
  • Spinal cord injuries

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

Bombardier, Charles H. ; Fann, Jesse R. ; Wilson, Catherine S. ; Heinemann, Allen W. ; Richards, J. Scott ; Warren, Ann Marie ; Brooks, Larry ; Warms, Catherine A. ; Temkin, Nancy R. ; Tate, Denise G. / A randomized controlled trial of venlafaxine XR for major depressive disorder after spinal cord injury : Methods and lessons learned. In: Journal of Spinal Cord Medicine. 2014 ; Vol. 37, No. 3. pp. 247-263.
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abstract = "Context/objective: We describe the rationale, design, methods, and lessons learned conducting a treatment trial for major depressive disorder (MDD) or dysthymia in people with spinal cord injury (SCI). Design: A multi-site, double-blind, randomized (1:1) placebo controlled trial of venlafaxine XR for MDD or dysthymia. Subjects were block randomized and stratified by site, lifetime history of substance dependence, and prior history of MDD. Setting: Six SCI centers throughout the United States. Participants: Across participating centers, 2536 subjects were screened and 133 were enrolled into the trial. Subjects were 18-64 years old and at least 1 month post-SCI. Interventions: Twelve-week trial of venlafaxine XR versus placebo using a flexible titration schedule. Outcome measures: The primary outcome was improvement in depression severity at 12 weeks. The secondary outcome was improvement in pain. Results: This article includes study methods, modifications prompted by a formative review process, preliminary data on the study sample and lessons learned. We describe common methodological and operational challenges conducting multi-site trials and how we addressed them. Challenges included study organization and decision making, staff training, obtaining human subjects approval, standardization of measurement and treatment, data and safety monitoring, subject screening and recruitment, unblinding and continuity of care, database management, and data analysis. Conclusions: The methodological and operational challenges we faced and the lessons we learned may provide useful information for researchers who aim to conduct clinical trials, especially in the area of medical treatment of depression in people with SCI.",
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Bombardier, CH, Fann, JR, Wilson, CS, Heinemann, AW, Richards, JS, Warren, AM, Brooks, L, Warms, CA, Temkin, NR & Tate, DG 2014, 'A randomized controlled trial of venlafaxine XR for major depressive disorder after spinal cord injury: Methods and lessons learned', Journal of Spinal Cord Medicine, vol. 37, no. 3, pp. 247-263. https://doi.org/10.1179/2045772313Y.0000000138

A randomized controlled trial of venlafaxine XR for major depressive disorder after spinal cord injury : Methods and lessons learned. / Bombardier, Charles H.; Fann, Jesse R.; Wilson, Catherine S.; Heinemann, Allen W.; Richards, J. Scott; Warren, Ann Marie; Brooks, Larry; Warms, Catherine A.; Temkin, Nancy R.; Tate, Denise G.

In: Journal of Spinal Cord Medicine, Vol. 37, No. 3, 05.2014, p. 247-263.

Research output: Contribution to journalReview article

TY - JOUR

T1 - A randomized controlled trial of venlafaxine XR for major depressive disorder after spinal cord injury

T2 - Methods and lessons learned

AU - Bombardier, Charles H.

AU - Fann, Jesse R.

AU - Wilson, Catherine S.

AU - Heinemann, Allen W.

AU - Richards, J. Scott

AU - Warren, Ann Marie

AU - Brooks, Larry

AU - Warms, Catherine A.

AU - Temkin, Nancy R.

AU - Tate, Denise G.

PY - 2014/5

Y1 - 2014/5

N2 - Context/objective: We describe the rationale, design, methods, and lessons learned conducting a treatment trial for major depressive disorder (MDD) or dysthymia in people with spinal cord injury (SCI). Design: A multi-site, double-blind, randomized (1:1) placebo controlled trial of venlafaxine XR for MDD or dysthymia. Subjects were block randomized and stratified by site, lifetime history of substance dependence, and prior history of MDD. Setting: Six SCI centers throughout the United States. Participants: Across participating centers, 2536 subjects were screened and 133 were enrolled into the trial. Subjects were 18-64 years old and at least 1 month post-SCI. Interventions: Twelve-week trial of venlafaxine XR versus placebo using a flexible titration schedule. Outcome measures: The primary outcome was improvement in depression severity at 12 weeks. The secondary outcome was improvement in pain. Results: This article includes study methods, modifications prompted by a formative review process, preliminary data on the study sample and lessons learned. We describe common methodological and operational challenges conducting multi-site trials and how we addressed them. Challenges included study organization and decision making, staff training, obtaining human subjects approval, standardization of measurement and treatment, data and safety monitoring, subject screening and recruitment, unblinding and continuity of care, database management, and data analysis. Conclusions: The methodological and operational challenges we faced and the lessons we learned may provide useful information for researchers who aim to conduct clinical trials, especially in the area of medical treatment of depression in people with SCI.

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KW - Antidepressants

KW - Dysthymia

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KW - Pain

KW - Randomized controlled trials

KW - Research design

KW - Spinal cord injuries

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