Treatment of Mild to Moderate Depression Symptoms in Patients With Spinal Cord Injury
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Treatment of Mild to Moderate Depression Symptoms in Patients With Spinal Cord Injury|
- 16-Item Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR16) [ Time Frame: Baseline and Week 13 ] [ Designated as safety issue: No ]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).
- Depression Scale of the Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline and weeks 1, 2, 3, 5, 9, 13, 14, 15, 16, 18, 20 and 26 weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||June 2008|
|Study Completion Date:||August 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Venlafaxine HCl is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) and has been approved by the FDA for the treatment of major depressive disorder. The treatment group will receive a sub-therapeutic dose over a two week period, with a two week titration, starting at 37.5 mg up to a maximum dose of 150 mg per day. At the end of the treatment period, dosage was tapered down in a step-wise fashion over a period of three weeks; 75 mg. for two weeks and 37.5 mg. for one week. While this was the standard protocol, study drug tapering was individualized based on side effects and the clinical judgment of the prescriber.
Drug: Venlafaxine HCl
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 Name: Effexor XR
Placebo Comparator: Placebo
Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
Subjects received a placebo instead of Venlafaxine HCl until week 13 as did the Venlafaxine group.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00735670
|United States, Michigan|
|University of Michigan Model SCI Care System|
|Ann Arbor, Michigan, United States, 48109-5491|
|Principal Investigator:||Denise G Tate, Ph.D.||University of Michigan Department of Physical Medicine and Rehabilitation|
|Study Director:||Anthony Chiodo, M.D.||University of Michigan|