Treatment of Mild to Moderate Depression Symptoms in Patients With Spinal Cord Injury

Official Title: “Treatment of Mild to Moderate Depression Symptoms in Patients With Spinal Cord Injury”

This study proposes to test the efficacy of Venlafaxine HCI in reducing mild to moderate symptoms of depression among persons with Spinal Cord Injury (SCI). This study recruits either traumatic or non-traumatic injured persons with SCI living in the community.

The successes of psychological and pharmacological modes of intervention in treating depression, both alone and combined, are well documented in the literature. While a great deal of research has identified specific clinical indications for many antidepressants currently available in the general population, little is known about the clinical indications of these agents in SCI. This study is proposed to test the benefits of Venlafaxine HCI (Effexor XR) for reducing mild to moderate symptoms of depression among people with SCI. As a secondary outcome, this study will assess also the benefits of this medication in reducing severity of symptoms of pain, and enhancing subjects' perceived health and participation in the community. The intervention will last 12 weeks and there will be 13 assessments and data collection points. Data will be collected at 26 weeks also.

Eight face to face contacts are anticipated.

Intervention(s) in this Clinical Trial

• Drug: Venlafaxine HCI
  • Starting dose is 37.5 mg and ending dose is 150 mg at 13 weeks. From weeks 13 to 26 subjects no longer will receive the drug
• Other: Placebo
  • Subjects will receive a placebo instead of drug for 6 months during the duration of treatment

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Subjects will be provided with the medication starting at 37.5 mg and ending at 150 mg. for 13 weeks when they start titrating down back to 75mg at 13 weeks and 37.5 mg at 15 weeks. They receive no drugs from weeks 16th to 26ths when the study ends.There are 13 assessments and data collection points for this study. These include 3 face to face assessments at baseline, 13 weeks and 26 weeks. Additional contacts will be done via telephone calls.
• Placebo Comparator: B
  • Subjects will receive a placebo instead of medication with all other conditions being the same including placebo doses. The study drug or placebo will be dispensed following this same schedule by IDS eight times per study subject. This may vary slightly depending on response to treatment, etc.

Primary Measures

• The Patient Health Questionnaire-9 (PHQ-9)
  • Time Frame: Assessed at baseline, weekly from weeks 1-5, week 9 at the end of treatment and then 3 months (week13) and after another 12 months (week26)
    Safety Issue?: No
• The Beck Scale for Suicide Ideation (BSS)
  • Time Frame: same as PHQ-9
    Safety Issue?: Yes
• 16 item Quick Inventory of Depressive Symptomatology (QIDS- SR16)
  • Time Frame: Baseline; weeks 13 and 26
    Safety Issue?: No

Secondary Measures

• The SCI Pain Instrument (SCIPI)
  • Time Frame: Baseline; weeks 13 and 26
    Safety Issue?: No
• The Adherence and Side Effects Checklist
  • Time Frame: Same as PHQ-9
    Safety Issue?: Yes
• CAGE & Drug Use
  • Time Frame: Same as PHQ-9
    Safety Issue?: Yes
• Generalized Anxiety Disorder-7 (GAD-7)
  • Time Frame: Baseline; weeks 13 and 26
    Safety Issue?: No
• The Perceived Stress Scale (PSS)
  • Time Frame: baseline, 13 and 26 weeks
    Safety Issue?: No
• Life Experiences Survey - Disability (LES-D)
  • Time Frame: baseline; 13 and 26 weeks
    Safety Issue?: No
• The Received Social Support and Social Undermining Scale (RSS/SU)
  • Time Frame: baseline; 13 and 26 weeks
    Safety Issue?: No
• Measure of the Quality of the Environment
  • Time Frame: baseline; 13 and 26 weeks
    Safety Issue?: No
• The Perceived Handicap Questionnaire (PHQ)
  • Time Frame: baseline; 13 and 26 weeks
    Safety Issue?: No
• Craig Handicap Assessment and Reporting Form - Short Form (CHART-SF)
  • Time Frame: baseline; 13 and 26 weeks
    Safety Issue?: No
• The SF-12 Health Status Questionnaire - 12
  • Time Frame: baseline; 13 and 26 weeks
    Safety Issue?: No

Inclusion Criteria:

• Having incurred a SCI at least one year prior to enrollment
• Neurological impairment ASIA Grades A-D with some associated functional limitations
• PHQ 9 scores of 5 - 14 (mild to moderate symptom severity)
• English speaker
• Age 18 years or older
• Completed informed consent and agreement to release protected health information (PHI) under the rules established by HIPAA
• Able to communicate with study personnel

Exclusion Criteria:

• Presence of cognitive deficits precluding and giving informed consent and completion of survey based assessment tools
• Psychiatric contraindications (suicidal ideation, history of suicidal attempts, alcohol and drug dependency, other psychiatric diagnosis including bipolar disorder)
• Medical contraindications (terminal illness or unstable medical condition as determined by medical history and/or examination)
• Pregnant or unwilling to use birth control if female and sexually active
• Presence of glaucoma
• Prior use of study drug without success or being treated with another antidepressant medication
• Presence of glaucoma
• Engagement in another experimental study within 30 days
• Expectation of major surgery within the following 12 weeks

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of Michigan Other

Overall Clinical Trial Officials and Contacts

Anthony Chiodo, M.D. Principal Investigator University of Michigan Department of Physical Medicine and Rehabilitation  

Overall Contact: Linda Berlin, MA (734) 763-0971 lspencer@umich.edu

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00735670

Study ID Number: NDNO60032SS

ClinicalTrials.gov Identifier: NCT00735670

Health Authority: United States: Institutional Review Board

University of Michigan Model SCI Care System