Trial Outcomes & Findings for Treatment of Mild to Moderate Depression Symptoms in Patients With Spinal Cord Injury (NCT NCT00735670)
NCT ID: NCT00735670
Last Updated: 2016-10-13
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
Baseline and Week 13
Results posted on
2016-10-13
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Mild to Moderate Depression Symptoms in Patients With Spinal Cord Injury
Baseline characteristics by cohort
| Measure |
Venlafaxine
n=10 Participants
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
n=11 Participants
Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
45.4 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
51.7 years
STANDARD_DEVIATION 14.1 • n=7 Participants
|
48.7 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Time since injury
|
10.01 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
13.64 years
STANDARD_DEVIATION 15.1 • n=7 Participants
|
11.9 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Level of injury
Tetraplegia
|
6 participants
n=5 Participants
|
1 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Level of injury
Paraplegia
|
4 participants
n=5 Participants
|
10 participants
n=7 Participants
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 13Population: Participants who completed the week 13 assessment.
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).
Outcome measures
| Measure |
Venlafaxine
n=6 Participants
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
n=6 Participants
Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
|
|---|---|---|
|
16-Item Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR16)
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and weeks 1, 2, 3, 5, 9, 13, 14, 15, 16, 18, 20 and 26 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Venlafaxine
n=10 Participants
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
n=11 Participants
Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
|
|---|---|---|
|
Depression Scale of the Patient Health Questionnaire (PHQ-9)
Overall Mean
|
4.84 units on a scale
Standard Deviation 3.66
|
5.46 units on a scale
Standard Deviation 4.48
|
|
Depression Scale of the Patient Health Questionnaire (PHQ-9)
Baseline
|
8.9 units on a scale
Standard Deviation 1.12
|
10.36 units on a scale
Standard Deviation 3.58
|
|
Depression Scale of the Patient Health Questionnaire (PHQ-9)
Week 1 (7Ven, 6Plac)
|
7 units on a scale
Standard Deviation 3.36
|
9.67 units on a scale
Standard Deviation 2.94
|
|
Depression Scale of the Patient Health Questionnaire (PHQ-9)
Week 2 (6Ven, 6Plac)
|
4.5 units on a scale
Standard Deviation 2.16
|
5.00 units on a scale
Standard Deviation 4.14
|
|
Depression Scale of the Patient Health Questionnaire (PHQ-9)
Week 3 (6Ven, 6Plac)
|
2.67 units on a scale
Standard Deviation 1.96
|
5.00 units on a scale
Standard Deviation 4.00
|
|
Depression Scale of the Patient Health Questionnaire (PHQ-9)
Week 5 (6Ven, 6Plac)
|
4.33 units on a scale
Standard Deviation 2.58
|
3.83 units on a scale
Standard Deviation 3.37
|
|
Depression Scale of the Patient Health Questionnaire (PHQ-9)
Week 9 (5Ven, 7Plac)
|
4.80 units on a scale
Standard Deviation 2.68
|
4.71 units on a scale
Standard Deviation 5.12
|
|
Depression Scale of the Patient Health Questionnaire (PHQ-9)
Week 13 (6Ven, 6Plac)
|
5.67 units on a scale
Standard Deviation 5.1
|
3.33 units on a scale
Standard Deviation 4.36
|
|
Depression Scale of the Patient Health Questionnaire (PHQ-9)
Week 14 (4Ven, 6Plac)
|
4.25 units on a scale
Standard Deviation 2.21
|
4.17 units on a scale
Standard Deviation 4.31
|
|
Depression Scale of the Patient Health Questionnaire (PHQ-9)
Week 15 (5Ven, 5 Plac)
|
1.80 units on a scale
Standard Deviation 1.30
|
3.20 units on a scale
Standard Deviation 3.96
|
|
Depression Scale of the Patient Health Questionnaire (PHQ-9)
Week 16 (4Ven, 6 Plac)
|
2.00 units on a scale
Standard Deviation 1.41
|
3.20 units on a scale
Standard Deviation 4.14
|
|
Depression Scale of the Patient Health Questionnaire (PHQ-9)
Week 18 (4Ven, 5Plac)
|
2.25 units on a scale
Standard Deviation 2.21
|
4.00 units on a scale
Standard Deviation 3.08
|
|
Depression Scale of the Patient Health Questionnaire (PHQ-9)
Week 20 (6Ven, 4Plac)
|
3.67 units on a scale
Standard Deviation 3.98
|
4.75 units on a scale
Standard Deviation 4.64
|
|
Depression Scale of the Patient Health Questionnaire (PHQ-9)
Week 26 (6Ven, 5Plac)
|
5.50 units on a scale
Standard Deviation 3.67
|
4.40 units on a scale
Standard Deviation 4.27
|
Adverse Events
Venlafaxine
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Venlafaxine
n=10 participants at risk
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
n=11 participants at risk
Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
|
|---|---|---|
|
Renal and urinary disorders
kidney infection (unrelated)
|
10.0%
1/10 • Number of events 1 • May 2009 through January 2012
|
0.00%
0/11 • May 2009 through January 2012
|
Other adverse events
| Measure |
Venlafaxine
n=10 participants at risk
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
n=11 participants at risk
Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
|
|---|---|---|
|
General disorders
Side effects
|
30.0%
3/10 • Number of events 3 • May 2009 through January 2012
|
36.4%
4/11 • Number of events 4 • May 2009 through January 2012
|
|
Psychiatric disorders
Onset of major depressive episode
|
0.00%
0/10 • May 2009 through January 2012
|
9.1%
1/11 • Number of events 1 • May 2009 through January 2012
|
|
General disorders
Suddenly stopped taking medication
|
10.0%
1/10 • Number of events 1 • May 2009 through January 2012
|
0.00%
0/11 • May 2009 through January 2012
|
Additional Information
Dr. Denise G Tate
University of Michigan Spinal Cord Injury System
Phone: 734 763-0971
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place