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
Intervention: venlafaxine XR; placebo
Intervention description: 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
Intervention MeSH terms: Venlafaxine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 133.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: spinal cord injuries; major depressive disorder; dysthymia; antidepressant agents; pain; quality of life; muscle spasticity; community participation; anxiety

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Spinal cord injury (ASIA A-D)

          -  At least one month post injury

          -  Meets DSM IV criteria for major depression or dysthymia on the SCID

          -  At least moderately severe depression (PHQ-9 score >= 10)

          -  Within reasonable travel distance to one of the study sites

        Exclusion Criteria:

          -  Current DSM IV alcohol or drug dependence

          -  History of bipolar disorder or psychosis

          -  History of >= 2 suicide attempts or suicide attempt with 5 years

          -  Current suicidal intent or plan

          -  Medical contraindications

          -  Non-English speaker

          -  Clinically significant cognitive/language impairment

          -  History of allergic reaction to venlafaxine XR or use of MAO-I with 2 weeks

          -  Current use of antidepressant medications (will not exclude if on low dose of a
             tricyclic antidepressant or trazodone for pain, sleep, or bladder), psychotherapy for
             depression, or electroconvulsive therapy

          -  Pregnant or lactating women or women of childbearing potential who are not willing to
             use a reliable form of contraception

          -  Unstable medical condition, as determined by physical examination, CBC w/ platelets
             (including hematocrit, hemoglobin, WBC, differential), serum chemistry panel (serum
             sodium, potassium, chloride, bicarbonate, BUN, creatinine, glucose), liver
             transaminases (AST, ALT), thyroid stimulating hormone (TSH), urinalysis, supine
             diastolic blood pressure (SDBP) > 90 mm Hg, or near terminal illness (primary care
             physician estimates that patient has < 1 year to live)

          -  Anticipated major surgical procedures within the 12 weeks of randomization

          -  Use of an investigational drug within 30 days

          -  Use of psychoactive medications, including corticosteroids and anticonvulsants, that
             have not been at a stable dose for at least 2 weeks

          -  Use of anxiolytic, sedative-hypnotic, or other psychotropic drug or substance
             (including St. John's Wort) within 7 days of start of double-blind treatment. If the
             patient is taking a sedative deemed necessary for sleep induction or spasticity, the
             dosage must have been stable for at least 2 weeks. Use of anticholinergic, low-dose
             tricyclic antidepressant, GABAergic or adrenergic medications for spasticity are
             permitted if at a stable dose for at least 2 weeks.

          -  Refusal to participate