Trial Outcomes & Findings for Treatment of Post-Traumatic Brain Injury (TBI) Depression (NCT NCT00233103)
NCT ID: NCT00233103
Last Updated: 2015-11-13
Results Overview
The 17-item Hamilton Rating Scale for Depression (HAM-D) is a widely used clinician-rated measurement of depression severity. A score of 0-7 is considered to be normal. 8-13 = mild depression, 14-18 = moderate depression, 19-22 = severe depression, and ≥ 23 = very severe depression. Self-report of depression and DSM-IV diagnosis (HAM-D score) at baseline.
COMPLETED
PHASE2
52 participants
baseline
2015-11-13
Participant Flow
Participants were recruited through physician referrals and flyers posted in outpatient rehabilitation treatment areas and distributed at TBI-survivor groups. Participants from past research projects who had agreed to be contacted for future studies were contacted.
Participant milestones
| Measure |
Sertraline
Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg) for 10 weeks
|
Placebo
Placebo for 10 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
25
|
|
Overall Study
COMPLETED
|
22
|
19
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Post-Traumatic Brain Injury (TBI) Depression
Baseline characteristics by cohort
| Measure |
Sertraline
n=22 Participants
Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
|
Placebo
n=19 Participants
Placebo for 10 weeks
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.8 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
51.5 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
49.1 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baselineThe 17-item Hamilton Rating Scale for Depression (HAM-D) is a widely used clinician-rated measurement of depression severity. A score of 0-7 is considered to be normal. 8-13 = mild depression, 14-18 = moderate depression, 19-22 = severe depression, and ≥ 23 = very severe depression. Self-report of depression and DSM-IV diagnosis (HAM-D score) at baseline.
Outcome measures
| Measure |
Sertraline
n=22 Participants
Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
|
Placebo
n=19 Participants
Placebo for 10 weeks
|
|---|---|---|
|
Depression at Baseline
|
27.5 units on a scale
Standard Deviation 7.1
|
25.2 units on a scale
Standard Deviation 8.0
|
PRIMARY outcome
Timeframe: end of treatment, average of 10 weeksSelf-report of depression and Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-IV) diagnosis (HAM-D score) compared at end of treatment to baseline. Participants were considered treatment responders if their initial HAM-D decreased by 50% or dropped below a score of 10 at the end of the intervention. The 17-item Hamilton Rating Scale for Depression (HAM-D) is a widely used clinician-rated measurement of depression severity. A score of 0-7 is considered to be normal. 8-13 = mild depression, 14-18 = moderate depression, 19-22 = severe depression, and ≥ 23 = very severe depression.
Outcome measures
| Measure |
Sertraline
n=22 Participants
Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
|
Placebo
n=19 Participants
Placebo for 10 weeks
|
|---|---|---|
|
Depression at End of Treatment
|
13.7 units on a scale
Standard Deviation 9.7
|
16.2 units on a scale
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: Immediately post-interventionThe Beck Anxiety Inventory (BAI) is a 21-item self-report measure that assesses subjective, somatic, or panic-related symptoms associated with anxiety rated on a scale from 0 (not at all) to 3(severely). Total score: 0-7 = minimal level of anxiety, 8-15 = mild anxiety, 16-25 = moderate anxiety, and 26-63 = severe depression
Outcome measures
| Measure |
Sertraline
n=22 Participants
Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
|
Placebo
n=19 Participants
Placebo for 10 weeks
|
|---|---|---|
|
BAI
|
11.1 units on a scale
Standard Deviation 11.9
|
13.1 units on a scale
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: Immediately post-intervention at 10 weeksLife-3 is a single-item Quality of life (QOL) measure that uses a 7-point Likert-type scale to assess satisfaction with life during the past month. It is typically administered twice during an evaluation, and the mean of the 2 obtained scores is used. Higher scores on this measure indicate higher levels of subjective QOL. Range from 1 to 7.
Outcome measures
| Measure |
Sertraline
n=22 Participants
Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
|
Placebo
n=19 Participants
Placebo for 10 weeks
|
|---|---|---|
|
Life-3
|
6.3 units on a scale
Standard Deviation 8.0
|
4.9 units on a scale
Standard Deviation 3.5
|
Adverse Events
Sertraline
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sertraline
n=22 participants at risk
Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
|
Placebo
n=19 participants at risk
Placebo for 10 weeks
|
|---|---|---|
|
Psychiatric disorders
anxiety
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Psychiatric disorders
depression
|
0.00%
0/22
|
5.3%
1/19 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
allergic reaction
|
0.00%
0/22
|
5.3%
1/19 • Number of events 1
|
Additional Information
Wayne A Gordon, PhD
Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place