Trial Outcomes & Findings for Treatment for Post-Stroke Depression (NCT NCT00029172)
NCT ID: NCT00029172
Last Updated: 2023-02-16
Results Overview
Depression remission was defined as HAM-D less than 8 or HAM-D decreased by 50%. The Hamilton Rating Scale for Depression is measured on a scale from no depression - major depression, 0-52 units on a scale.
COMPLETED
PHASE4
188 participants
Twelve week
2023-02-16
Participant Flow
Subjects were recruited from 4 Indianapolis based hospitals. Depression enrollment and screening occurred between 1 and 2 months post stroke.
Participant milestones
| Measure |
Case Management
|
|---|---|
|
Overall Study
STARTED
|
188
|
|
Overall Study
COMPLETED
|
182
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment for Post-Stroke Depression
Baseline characteristics by cohort
| Measure |
Case Management
n=182 Participants
|
|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 3 • n=99 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
182 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Twelve weekDepression remission was defined as HAM-D less than 8 or HAM-D decreased by 50%. The Hamilton Rating Scale for Depression is measured on a scale from no depression - major depression, 0-52 units on a scale.
Outcome measures
| Measure |
Case Management
n=182 Participants
|
|---|---|
|
Twelve Week Depression Outcomes
|
10.6 HAM-D depression score
Standard Deviation 6.9
|
Adverse Events
Case Management
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place