Assessment of the efficacy of Venlafaxine HCl as a preventative therapy for depression and pain following spinal cord injuries: A randomized clinical trial
Principal Investigator Name
Anthony Chiodo, MD
Principal Investigator Email
Adults with spinal cord injury having mild to moderate symptoms of depression.
The study proposes to evaluate the efficacy of venlafaxine HCl as an agent for preventing the occurrence of depression among people with both new and existing spinal cord injuries (SCI). While pharmacological agents are commonly used for treating depression in this population, research to evaluate the efficacy of this approach to treatment has not been conducted as has the assessment of pharmacotherapy as a means of prevention. This is in spite of the fact that incidence rates are higher than in the general population and treatment efficacy of traditional therapies is seemingly less effective. Without the evidence from a clinical trial, clinicians will rightly remain uncertain about treatment guidelines. In assessing the effects of venlafaxine HCl on depression, it will also look at symptom reduction. A secondary focus of this study will be to look at its efficacy of venlafaxine HCI for treating neuropathic pain, which is prevalent among individuals with SCI. While not approved as a treatment for neuropathic pain, studies of venlafaxine HCl conducted in other populations suggest that it may be effective in this population. Pain and depression have well-known synergistic relationships: higher levels of depression exacerbating pain, and vice-versa. This will be double-blind, randomized clinical trial.
The study has three specific aims:
1) To assess whether people with SCI who receive Venlafaxine will have lower incidence of depression over a 3-month period than will those receiving a placebo.
2) To appraise whether people receiving Venlafaxine will have lower severities of symptoms of depression and pain than will those receiving placebo over a 3 month period.
3) To assess whether persons receiving Venlafaxine will have higher levels of perceived health, greater community participation, less stress, more overall activity, and greater employment-related engagement.
In addition, the study will explore three additional issues:
1) Whether there are long-term benefits to receipt of Venlafaxine; i.e., will study participants who received venlafaxine HCI have fewer symptoms of depression and pain during the 3-month period subsequent to the termination of the study intervention? Will they have higher levels of the outcomes listed in 3) above?
2) Among people with elevated levels of depression, will those taking Venlafaxine have lower levels of stress than those receiving placebo?
3) Will the impact of Venlafaxine be similar among those with new and long-term SCI.