Official Title: “Assessment of the Efficacy of Venlafaxine HCI as a Preventive Therapy for Depression and Pain Following New Spinal Cord Injuries: A Randomized Clinical Trial”

This study proposes to evaluate the efficacy of Venlafaxine HCI as a preventive agent for reducing occurrence of depression among people with spinal cord injuries (SCI). This study recruits both at the inpatient rehabilitation phase following admission with a diagnosis of SCI and after discharge from the hospital as an outpatient with SCI.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: January 2011

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) as a preventative agent for reducing the risk of depression symptom elevation 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 13 weeks and there will be 15 assessments and data collection points. Data will be collected at 26 weeks also.

Three 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 6 consecutive months
• Placebo Comparator: B
  • Subjects will receive a placebo instead of medication with all other conditions being the same including placebo doses

Primary Measures

• Symptoms of depression measured by the Patient Health Questionnaire (PHQ)
  • Time Frame: 3, 6 and 12 months after treatment starts
    Safety Issue?: No

Secondary Measures

• The Structured Clinical Interview for DSM-IV-TR (SCID) The SCI Pain Instrument (SCIPI); The Perceived Stress Scale (PSS) Impact on Participation and Autonomy Questionnaire (IPA)
  • Time Frame: 3, 6 and 12 months
    Safety Issue?: No

Inclusion Criteria:

• Having incurred a SCI which resulted in inpatient rehabilitation
• Receives(d) rehabilitation care (inpatient and/or outpatient) at the University of Michigan Hospital
• Neurological impairment ASIA Grades A-D
• English speaker
• Ages 18 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 and cognitively intact
• Currently not depressed or being treated with other anti-depressant medications; free of medical and psychiatric contra indications; not pregnant or willingness to use birth control
• No major history of drug or alcohol dependency and abuse, free of suicidal ideation and attempts history
• No prior use of venlafaxine HCI which was unsuccessful
• Free from glaucoma
• Not participating in another study at the same time
• No major surgery scheduled during this study time
• Not residing in a sub acute facility

Exclusion Criteria:

• Presence of cognitive deficits precluding participation and giving informed consent
• Psychiatric contraindications (suicidal ideation, history of suicidal attempts, alcohol and drug dependency, psychiatric diagnosis)
• Medical contraindications (terminal illness or unstable medical condition)
• 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
• Engagement in another experimental study
• Expectation of major surgery
• Discharge from inpatient rehabilitation to sub-acute facility

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 Sponsor: University of Michigan

Information obtained from ClinicalTrials.gov on July 02, 2009

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