An interventional study of Venlafaxine HCl and Placebo in Spinal Cord Injury, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-13.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
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.
1,991 studies on the registry are indexed under Spinal Cord Injuries; 516 are open to participants now.
This study's enrollment of 34 is above the median of 24 across 1,594 interventional studies indexed under Spinal Cord Injuries.
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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
Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
Other: Placebo
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
Also known as: Effexor XR
Subjects received a placebo instead of Venlafaxine HCl until week 13 as did the Venlafaxine group.
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
Recruitment into the final protocol began in May 2009 and continued through July 2011. Participants were recruited from the surrounding community through clinics, existing research studies, and community organizations.
| Milestone | Venlafaxine | Placebo |
|---|---|---|
| Started | 10 | 11 |
| Completed | 6 | 6 |
| Not completed | 4 | 5 |
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).
| participants | Venlafaxine | Placebo |
|---|---|---|
| 16-Item Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR16) | 2 | 0 |
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.
| units on a scale | Venlafaxine | Placebo |
|---|---|---|
| Overall Mean | 4.84 ± 3.66 | 5.46 ± 4.48 |
| Baseline | 8.9 ± 1.12 | 10.36 ± 3.58 |
| Week 1 (7Ven, 6Plac) | 7 ± 3.36 | 9.67 ± 2.94 |
| Week 2 (6Ven, 6Plac) | 4.5 ± 2.16 | 5.00 ± 4.14 |
| Week 3 (6Ven, 6Plac) | 2.67 ± 1.96 | 5.00 ± 4.00 |
| Week 5 (6Ven, 6Plac) | 4.33 ± 2.58 | 3.83 ± 3.37 |
| Week 9 (5Ven, 7Plac) | 4.80 ± 2.68 | 4.71 ± 5.12 |
| Week 13 (6Ven, 6Plac) | 5.67 ± 5.1 | 3.33 ± 4.36 |
| Week 14 (4Ven, 6Plac) | 4.25 ± 2.21 | 4.17 ± 4.31 |
| Week 15 (5Ven, 5 Plac) | 1.80 ± 1.30 | 3.20 ± 3.96 |
| Week 16 (4Ven, 6 Plac) | 2.00 ± 1.41 | 3.20 ± 4.14 |
| Week 18 (4Ven, 5Plac) | 2.25 ± 2.21 | 4.00 ± 3.08 |
| Week 20 (6Ven, 4Plac) | 3.67 ± 3.98 | 4.75 ± 4.64 |
| Week 26 (6Ven, 5Plac) | 5.50 ± 3.67 | 4.40 ± 4.27 |
Collected over May 2009 through January 2012. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Venlafaxine | — | 1/10 (10%) | 4/10 (40%) |
| Placebo | — | 0/11 (0%) | 5/11 (45.5%) |
| Event | Venlafaxine | Placebo |
|---|---|---|
| kidney infection (unrelated)Renal and urinary disorders | 1/10 | 0/11 |
| Event | Venlafaxine | Placebo |
|---|---|---|
| Side effectsGeneral disorders | 3/10 | 4/11 |
| Suddenly stopped taking medicationGeneral disorders | 1/10 | 0/11 |
| Onset of major depressive episodePsychiatric disorders | 0/10 | 1/11 |
Participants meeting eligibility criteria for the final protocol version.
| Age, Categorical(Participants) | Venlafaxine | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 10 | 20 |
| >=65 years | 0 | 1 | 1 |
| Age, Continuous(years) | Venlafaxine | Placebo | Total |
|---|---|---|---|
| Mean | 45.4 ± 10.5 | 51.7 ± 14.1 | 48.7 ± 12.6 |
| Sex: Female, Male(Participants) | Venlafaxine | Placebo | Total |
|---|---|---|---|
| Female | 2 | 2 | 4 |
| Male | 8 | 9 | 17 |
| Region of Enrollment(participants) | Venlafaxine | Placebo | Total |
|---|---|---|---|
| United States | 10 | 11 | 21 |
| Time since injury(years) | Venlafaxine | Placebo | Total |
|---|---|---|---|
| Mean | 10.01 ± 9.0 | 13.64 ± 15.1 | 11.9 ± 10.0 |
| Level of injury(participants) | Venlafaxine | Placebo | Total |
|---|---|---|---|
| Tetraplegia | 6 | 1 | 7 |
| Paraplegia | 4 | 10 | 14 |
The record gives a start of Jun 2008, a primary completion of Jun 2012 and a completion of Aug 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2016, 4 years 4 months after primary completion.
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Studies of the drug tested here: Venlafaxine