This study was initially designed to test the efficacy of Venlafaxine HCl in reducing incidence of the onset of major depression after a new spinal cord injury (SCI). After several protocol modifications, the purpose of the study is to test the effectiveness of a sub-therapeutic dose of Venlafaxine HCl to reduce mild to moderate symptoms in persons with SCI.
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. 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. Because of the change in protocol to reducing mild to moderate symptoms and substantially lower enrollment than anticipated (1/6th of what we anticipated), we deleted a number of study outcomes listed in the 2011 posting of this study. Most of these were not part of the original posting in 2008, and those that were deleted were no longer relevant to new protocol's focus on reducing mild to moderate depression. The two outcomes reported here were most relevant to the revised protocol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
34
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
Subjects received a placebo instead of Venlafaxine HCl until week 13 as did the Venlafaxine group.
University of Michigan Model SCI Care System
Ann Arbor, Michigan, United States
16-Item Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR16)
The QIDS assesses symptoms of depression across the nine DSM-IV criterion domains for major depressive episode. The primary end-point in this study was the number of participants who had a \>50% change in scores on the QIDs from baseline to week 13 (end of treatment period).
Time frame: Baseline and Week 13
Depression Scale of the Patient Health Questionnaire (PHQ-9)
The nine items of the PHQ-9 are based directly on the nine diagnostic criteria for major depressive disorder in the DSM-IV. Higher total scores indicate more severe symptomatology, ranging from 0 (no symptoms) to 27 (most severe symptoms). Data in the tables begin with the overall mean for each group that includes all subjects, average across all assessment time points. Each subsequent row reports the mean and standard deviation of each time point by allocation, noting sample size for each group in the arm/group title given missing data in each time point after baseline.
Time frame: Baseline and weeks 1, 2, 3, 5, 9, 13, 14, 15, 16, 18, 20 and 26 weeks
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