NCT00592384: PRISMS

A Controlled Trial of Venlafaxine XR for Major Depression After Spinal Cord Injury: A Multi-site Study

Completed Phase 4 Results posted Last updated 31 December 2014

What this trial tests

Phase 4 trial testing venlafaxine XR in Major Depressive Disorder in 133 participants. Completed in 1 September 2012.

Timeline

1 July 2007

Primary endpoint
1 September 2012

1 September 2012

Quick facts

Lead sponsor	University of Washington
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	133
Start date	1 July 2007
Primary completion	1 September 2012
Estimated completion	1 September 2012
Sites	6 locations across United States

Drugs / interventions tested

• venlafaxine XR — full drug profile →
• placebo

Conditions studied

• Major Depressive Disorder — all drugs for Major Depressive Disorder →
• Dysthymia — all drugs for Dysthymia →
• Spinal Cord Injuries — all drugs for Spinal Cord Injuries →

Sponsor

University of Washington

Who can join

Adults 18 to 64, any sex, with Major Depressive Disorder or Dysthymia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Hamilton Depression Rating Scale-17
  Time frame: 0 weeks, 12 weeks
  The 17-item Hamilton Depression Rating Scale is a clinician rated measure of depression severity (we used a structured interview version (Williams 1988) to improve inter-rater reliability). Scores range from 0-52. Higher scores indicate more severe depression. Scores of 7 or less indicate remission from depression.
• Hamilton Depression Rating Scale-Maier Subscale
  Time frame: 0 weeks, 12 weeks
  The Maier is a 6-item sub scale of the Hamilton derived from Rasch analysis. It is a unidimensional scale with superior sensitivity to change. It excludes somatic items and is therefore especially appropriate for individuals who have substantial physical impairment and medical comorbidity. Scores can range from 0-22 with higher scores indicating more severe depression. Scores of 4 or less indicate

Sponsor's own description

Depression is likely the most prevalent and disabling psychological complication associated with spinal cord injury (SCI). Yet no controlled depression treatment trials have been performed in this population. The proposed study is a multi-site, randomized, double-blind, placebo controlled trial of venlafaxine XR (Effexor XR) in 133 adults with SCI and major depressive disorder (MDD) or dysthymia who are at least one month post injury. Participants will be recruited from four SCI Model System sites, the University of Washington, Rehabilitation Institute of Chicago, University of Michigan, University of Alabama, Birmingham and Baylor Institute for Rehabilitation, Dallas, TX. The purpose of the study is to examine the efficacy and tolerability of venlafaxine XR as a treatment for MDD. The primary outcome will be the percent of responders (those who report at least a 50% reduction in depression severity from baseline to the end of treatment) in the venlafaxine XR versus placebo control group using intent-to-treat analysis. Secondary outcomes will include changes in pain, health related quality of life depression-related disability and community participation. A successful clinical trial could lead to more aggressive identification and treatment of MDD as well as improved health and quality of life in this important population.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antidepressants for pain management in adults with chronic pain: a network meta-analysis.
   Birkinshaw H, Friedrich CM, Cole P, Eccleston C, et al · · 2023 · cited 89× · PMID 37160297 · DOI 10.1002/14651858.cd014682.pub2
2. Venlafaxine extended-release for depression following spinal cord injury: a randomized clinical trial.
   Fann JR, Bombardier CH, Richards JS, Wilson CS, et al · · 2015 · cited 32× · PMID 25607727 · DOI 10.1001/jamapsychiatry.2014.2482