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| ID | Type | Description | Link |
|---|---|---|---|
| NIDRRH133N060032 |
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| Name | Class |
|---|---|
| U.S. Department of Education | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venlafaxine | Experimental | 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. |
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| Placebo | Placebo Comparator | Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venlafaxine HCl | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and Week 13 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Denise G Tate, Ph.D. | University of Michigan Department of Physical Medicine and Rehabilitation | Principal Investigator |
| Anthony Chiodo, M.D. | University of Michigan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Model SCI Care System | Ann Arbor | Michigan | 48109-5491 | United States |
Because of challenges of recruiting inpatients with new injuries, the final modification to the protocol was to restrict inclusion criteria to those with chronic SCI (>6 months after injury) and the objective of the study shifted from preventing a major depressive episode to a reduction in symptoms. Therefore 13 / 34 enrolled were ineligible.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Venlafaxine | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants meeting eligibility criteria for the final protocol version.
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| ID | Title | Description |
|---|---|---|
| BG000 | Venlafaxine | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Participants who completed the week 13 assessment. | Posted | Number | participants | Baseline and Week 13 |
|
May 2009 through January 2012
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Venlafaxine | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| kidney infection (unrelated) | Renal and urinary disorders | Systematic Assessment | Subject was hospitalized with kidney infection which was determined to be unrelated to the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Side effects | General disorders | Systematic Assessment | Includes side effects of feeling "spacey", sleepiness, drowsiness, sexual dysfunction, irritability. |
Difficulties with recruitment and high rate of withdrawal (57%) resulted in a very small sample. As such, results must be taken with caution given low power in this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Denise G Tate | University of Michigan Spinal Cord Injury System | 734 763-0971 | dgtate@umich.edu |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D000069470 | Venlafaxine Hydrochloride |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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| Placebo | Other | Subjects received a placebo instead of Venlafaxine HCl until week 13 as did the Venlafaxine group. |
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| Baseline and weeks 1, 2, 3, 5, 9, 13, 14, 15, 16, 18, 20 and 26 weeks |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Time since injury | Mean | Standard Deviation | years |
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| Level of injury | Number | participants |
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| OG001 | 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. |
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| Secondary | 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. | Subjects with PHQ-9 data at any of the measurement time points (baseline, weeks 1, 2, 3, 5, 9, 13, 14, 15, 16, 18, 20 and 26 weeks) are included in the means reported for each time point. The sample size for each time point is given in the category title (e.g., 10Ven = 10 venlafaxine group or 11Plac = 11 placebo group) if it deviates from baseline. | Posted | Mean | Standard Deviation | units on a scale | Baseline and weeks 1, 2, 3, 5, 9, 13, 14, 15, 16, 18, 20 and 26 weeks |
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| 1 |
| 10 |
| 4 |
| 10 |
| EG001 | 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. | 0 | 11 | 5 | 11 |
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| Onset of major depressive episode | Psychiatric disorders | Systematic Assessment |
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| Suddenly stopped taking medication | General disorders | Systematic Assessment |
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| D014947 | Wounds and Injuries |
| Organic Chemicals |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D008055 | Lipids |
| Week 1 (7Ven, 6Plac) |
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| Week 2 (6Ven, 6Plac) |
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| Week 3 (6Ven, 6Plac) |
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| Week 5 (6Ven, 6Plac) |
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| Week 9 (5Ven, 7Plac) |
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| Week 13 (6Ven, 6Plac) |
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| Week 14 (4Ven, 6Plac) |
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| Week 15 (5Ven, 5 Plac) |
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| Week 16 (4Ven, 6 Plac) |
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| Week 18 (4Ven, 5Plac) |
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| Week 20 (6Ven, 4Plac) |
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| Week 26 (6Ven, 5Plac) |
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