Back to resultsTreatment of Mild to Moderate Depression Symptoms in Patients With Spinal Cord Injury
Primary Purpose
Spinal Cord Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Venlafaxine HCl
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury focused on measuring SCI
Eligibility Criteria
Inclusion Criteria:
- Having sustained an SCI at least six months prior to enrollment.
- Neurological impairment ASIA Grades A-D.
- Mild to moderate depressive symptoms.
- English speaker
- Age 18 years or older
- Able to communicate with study personnel
Exclusion Criteria:
- No neurological impairment due to SCI.
- Presence of cognitive deficits precluding and giving informed consent and completion of survey based assessment tools.
- Psychiatric contraindications (suicidal ideation, history of suicidal attempts, alcohol and drug dependency, other psychiatric diagnosis including bipolar disorder).
- Medical contraindications (terminal illness or unstable medical condition as determined by medical history and/or examination).
- Pregnant or unwilling to use birth control if female and sexually active.
- Presence of glaucoma.
- Prior use of study drug without success or being treated with another antidepressant medication and being unwilling to taper off to take the stud drug.
- Willing to travel to Ann Arbor Michigan.
- Expecting to take or currently taking another experimental study within 30 days
- Major surgery scheduled within 12 weeks
Sites / Locations
- University of Michigan Model SCI Care System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Venlafaxine
Placebo
Arm Description
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.
Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00735670
First Posted
August 14, 2008
Last Updated
October 7, 2016
Sponsor
University of Michigan
Collaborators
U.S. Department of Education
1. Study Identification
Unique Protocol Identification Number
NCT00735670
Brief Title
Treatment of Mild to Moderate Depression Symptoms in Patients With Spinal Cord Injury
Official Title
Treatment of Mild to Moderate Depression Symptoms in Patients With Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
U.S. Department of Education
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
SCI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Venlafaxine
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
Intervention Type
Drug
Intervention Name(s)
Venlafaxine HCl
Other Intervention Name(s)
Effexor XR
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Subjects received a placebo instead of Venlafaxine HCl until week 13 as did the Venlafaxine group.
Primary Outcome Measure Information:
Title
16-Item Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR16)
Description
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
Secondary Outcome Measure Information:
Title
Depression Scale of the Patient Health Questionnaire (PHQ-9)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Having sustained an SCI at least six months prior to enrollment.
Neurological impairment ASIA Grades A-D.
Mild to moderate depressive symptoms.
English speaker
Age 18 years or older
Able to communicate with study personnel
Exclusion Criteria:
No neurological impairment due to SCI.
Presence of cognitive deficits precluding and giving informed consent and completion of survey based assessment tools.
Psychiatric contraindications (suicidal ideation, history of suicidal attempts, alcohol and drug dependency, other psychiatric diagnosis including bipolar disorder).
Medical contraindications (terminal illness or unstable medical condition as determined by medical history and/or examination).
Pregnant or unwilling to use birth control if female and sexually active.
Presence of glaucoma.
Prior use of study drug without success or being treated with another antidepressant medication and being unwilling to taper off to take the stud drug.
Willing to travel to Ann Arbor Michigan.
Expecting to take or currently taking another experimental study within 30 days
Major surgery scheduled within 12 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise G Tate, Ph.D.
Organizational Affiliation
University of Michigan Department of Physical Medicine and Rehabilitation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anthony Chiodo, M.D.
Organizational Affiliation
University of Michigan
Official's Role
Study Director
Facility Information:
Facility Name
University of Michigan Model SCI Care System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5491
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment of Mild to Moderate Depression Symptoms in Patients With Spinal Cord Injury
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