Project to Improve Symptoms and Mood in People With Spinal Cord Injury
Condition: Major Depressive Disorder; Dysthymia; Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries; Depressive Disorder; Depression; Depressive Disorder, Major; Dysthymic Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      Depression is likely the most prevalent and disabling psychological complication associated
      with spinal cord injury (SCI). The prevalence of major depression in people with SCI is 22%
      or two to six times higher than in the general population. Depression is linked to a myriad
      of adverse outcomes including poor subjective health, poor community integration, higher
      rates of medical complications and high rates of suicide. Surprisingly there are no
      randomized controlled trials for treating major depressive disorder (MMD) in people with SCI.
      Despite the widespread use of antidepressants in this population, the common assumption that
      antidepressant medications are effective and well-tolerated among people with SCI is
      uncertain. Multiple factors such as severe stresses, bereavement and loss of rewarding
      activities may complicate treatment. Treatment trials suggest antidepressants may not be as
      effective in people with medical/neurological conditions as they are with depression that
      develops as a primary condition. For almost 20 years clinicians and scientists have called
      for controlled clinical trials of antidepressants among people with SCI in order to establish
      evidence-based treatment. The proposed study is a multi-site, randomized, double-blind,
      placebo controlled trial of venlafaxine XR (Effexor XR) in 133 adults with SCI and MDD or
      dysthymia who are at least one month post injury. Participants aged 18-64 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 and 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.
    

Intervention name(s): venlafaxine XR; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Once daily oral dose of venlafaxine XR ranging from 37.5 mg up to 300 mg; Once daily oral dose of placebo ranging from 37.5 mg up to 300 mg
Other intervention name(s): Effexor XR; identically encapsulated inactive substance
Intervention MeSH terms: Venlafaxine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: spinal cord injuries; major depressive disorder; dysthymia; antidepressant agents; pain; quality of life; muscle spasticity; community participation; anxiety