Trial Outcomes & Findings for Poststroke Depression in Hemorrhagic Stroke (NCT NCT03826875)

Last Updated: 2025-08-06

Results Overview

Depression will be assessed using the Hamilton Rating Scale for Depression (HAM-D). The HAM-D is a 21-item questionnaire to treat and diagnose severe depression. Examining a different symptom or aspect of depression, such as mood, guilt feelings, or suicidal ideation. The first 17 questions are used for scoring. The first 17 items used (8 items scored 0-4, 9 scored 0-2; min-max: 0-50): 0-7 normal, 8-13 mild, 14-18 moderate, 19-22 severe, ≥23 very severe depression.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

1 year

Results posted on

2025-08-06

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo	Drug Cohort Fluoxetine 20mg/day
Overall Study STARTED	4	4
Overall Study COMPLETED	3	2
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

HAM-D is a 21-item diagnostic/treating severe depression tool with only the first 17 items used (8 items scored 0-4, 9 scored 0-2; min-max: 0-50): 0-7 normal, 8-13 mild, 14-18 moderate, 19-22 severe, ≥23 very severe depression. PHQ-9 is a 9-item diagnostic/grading depression tool (min-max: 0-27): 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=4 Participants Placebo	Drug Cohort n=4 Participants Fluoxetine 20mg/day	Total n=8 Participants Total of all reporting groups
Age, Continuous	50.75 year STANDARD_DEVIATION 14.08 • n=93 Participants	60.25 year STANDARD_DEVIATION 9.74 • n=4 Participants	55.50 year STANDARD_DEVIATION 12.31 • n=27 Participants
Sex: Female, Male Female	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Sex: Female, Male Male	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=93 Participants	4 Participants n=4 Participants	8 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Baseline Hamilton Rating Scale for Depression (HAM-D)	11.5 Score STANDARD_DEVIATION 10.61 • n=93 Participants • HAM-D is a 21-item diagnostic/treating severe depression tool with only the first 17 items used (8 items scored 0-4, 9 scored 0-2; min-max: 0-50): 0-7 normal, 8-13 mild, 14-18 moderate, 19-22 severe, ≥23 very severe depression. PHQ-9 is a 9-item diagnostic/grading depression tool (min-max: 0-27): 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.	8.67 Score STANDARD_DEVIATION 6.81 • n=4 Participants • HAM-D is a 21-item diagnostic/treating severe depression tool with only the first 17 items used (8 items scored 0-4, 9 scored 0-2; min-max: 0-50): 0-7 normal, 8-13 mild, 14-18 moderate, 19-22 severe, ≥23 very severe depression. PHQ-9 is a 9-item diagnostic/grading depression tool (min-max: 0-27): 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.	9.80 Score STANDARD_DEVIATION 7.33 • n=27 Participants • HAM-D is a 21-item diagnostic/treating severe depression tool with only the first 17 items used (8 items scored 0-4, 9 scored 0-2; min-max: 0-50): 0-7 normal, 8-13 mild, 14-18 moderate, 19-22 severe, ≥23 very severe depression. PHQ-9 is a 9-item diagnostic/grading depression tool (min-max: 0-27): 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Baseline Patient Health Questionnaire (PHQ-9) Depression	10.25 Score STANDARD_DEVIATION 8.77 • n=93 Participants • HAM-D is a 21-item diagnostic/treating severe depression tool with only the first 17 items used (8 items scored 0-4, 9 scored 0-2; min-max: 0-50): 0-7 normal, 8-13 mild, 14-18 moderate, 19-22 severe, ≥23 very severe depression. PHQ-9 is a 9-item diagnostic/grading depression tool (min-max: 0-27): 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.	9.5 Score STANDARD_DEVIATION 6.81 • n=4 Participants • HAM-D is a 21-item diagnostic/treating severe depression tool with only the first 17 items used (8 items scored 0-4, 9 scored 0-2; min-max: 0-50): 0-7 normal, 8-13 mild, 14-18 moderate, 19-22 severe, ≥23 very severe depression. PHQ-9 is a 9-item diagnostic/grading depression tool (min-max: 0-27): 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.	9.88 Score STANDARD_DEVIATION 7.28 • n=27 Participants • HAM-D is a 21-item diagnostic/treating severe depression tool with only the first 17 items used (8 items scored 0-4, 9 scored 0-2; min-max: 0-50): 0-7 normal, 8-13 mild, 14-18 moderate, 19-22 severe, ≥23 very severe depression. PHQ-9 is a 9-item diagnostic/grading depression tool (min-max: 0-27): 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.

PRIMARY outcome

Timeframe: 1 year

Population: Patients withdrew

Outcome measures

Outcome measures
Measure	Placebo n=3 Participants Placebo	Drug Cohort n=2 Participants Fluoxetine 20mg/day
Depression	12.33 units on a scale Standard Deviation 3.21	6 units on a scale Standard Deviation 5.66

PRIMARY outcome

Timeframe: 1 year

Population: patients withdrew

Depression will be assessed using the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a 9 item questionnaire to treat and diagnose depression. The minimum score is 1, and the maximum score is 27. 1-4: minimal depression 5-9: mild depression 10-14: moderate depression 15-19: moderately severe depression 20-27: severe depression

Outcome measures

Outcome measures
Measure	Placebo n=3 Participants Placebo	Drug Cohort n=2 Participants Fluoxetine 20mg/day
Depression	5.67 units on a scale Standard Deviation 2.08	5.00 units on a scale Standard Deviation 7.07

SECONDARY outcome

Timeframe: 1 year

Population: patients withdrew

Anxiety will be assessed using the Hamilton Rating Scale for Anxiety. The Hamilton Anxiety Rating Scale measures the severity of anxiety through looking at both psychic and somatic anxiety. Each item is scored on a scale of 0 to 4, with a total range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

Outcome measures

Outcome measures
Measure	Placebo n=3 Participants Placebo	Drug Cohort n=2 Participants Fluoxetine 20mg/day
Anxiety	8.00 units on a scale Standard Deviation 3.61	9.50 units on a scale Standard Deviation 6.36

SECONDARY outcome

Timeframe: 1 year

Population: patients withdrew

Fatigue will be assessed using the Fatigue Severity Scale. The Fatigue Severity Scale measures the severity of fatigue and its effect on a person's activities and lifestyle in patients exhibiting depression. The scale is designed to differentiate fatigue from clinical depression since they share similar symptoms. Scoring is done by calculating the average response to the question and people with depression typically score about 4.5 whereas those with fatigue average about 6.5. A minimum score is 1, and a maximum score is 7 A score close to 4.5 is more likely to indicate depression. A score close to 6.5 is more likely to indicate fatigue.

Outcome measures

Outcome measures
Measure	Placebo n=3 Participants Placebo	Drug Cohort n=2 Participants Fluoxetine 20mg/day
Fatigue	2.71 units on a scale Standard Deviation 1.07	1.39 units on a scale Standard Deviation 0.08

SECONDARY outcome

Timeframe: 1 year

Population: participants withdrew

Healthcare Utilization will be assessed using the Self-Report Health Service Utilization and Medication Use. The Self-Report Health Service Utilization and Medication Use scale measures the frequency and purpose of healthcare utilization to include hospitalization, mental health care, inpatient admissions, outpatient visits, emergency room visits, skilled nursing facility/rehabilitation center visits, and medication usage. Scoring is the number of utilization per category per period. A minimum score is 0, and a maximum score is unlimited. A higher number indicates that the patient has utilized more health services and medication during 1 1-year time frame.

Outcome measures

Outcome measures
Measure	Placebo n=3 Participants Placebo	Drug Cohort n=2 Participants Fluoxetine 20mg/day
Healthcare Utilization	5.67 units on a scale Standard Deviation 8.46	23 units on a scale Standard Deviation 32.53

SECONDARY outcome

Timeframe: 1 year

Population: patients withdrew

Social Support will be assessed using the Multidimensional Scale of Perceived Social Support (MSPSS). The MSPSS is a scale to determine a patient's social support system from Family, Friends, and significant other. The scale is comprised of a total of 12 items with 4 items for each subscale. The following subscale can also be calculated but not utilized in the report: Significant other average responses from questions 1,2,5,10; Family average responses from questions 3,4,8,11; friends average responses from questions 6,7,9,12. The total scale score is calculated by adding all 12 questions, then dividing by 12. A minimum score is 1, and a maximum score is 7. Total Scale Score of: 1-2.9: low support 3-5: moderate support 5.1-7: high support

Outcome measures

Outcome measures
Measure	Placebo n=3 Participants Placebo	Drug Cohort n=2 Participants Fluoxetine 20mg/day
Social Support	6.80 units on a scale Standard Deviation 0.34	4.75 units on a scale Standard Deviation 0.95

SECONDARY outcome

Timeframe: 1 year

Population: patients withdrew

(PROMIS-Sleep Disturbance). PROMIS is a sleep disturbance scale used to assess the pure domain of sleep disturbance. The short form is scored based on using a data collection tool that automatically calculates scores and will be using responses to each item for each participant. Scoring: The total raw score for a measure will be converted according to the PROMIS Score. The conversion table will translate the total raw score into a T-score for each participant. The T-score rescales the raw into a standardized score with a mean of 50 and a standard deviation of 10. Therefore, a person with a T-score of 40 is one standard deviation below the mean. A higher PROMIS T-score represents more of the concept being measured.

Outcome measures

Outcome measures
Measure	Placebo n=3 Participants Placebo	Drug Cohort n=2 Participants Fluoxetine 20mg/day
Sleep Disturbance	48.97 T-score Standard Deviation 9.35	44.85 T-score Standard Deviation 0.92

SECONDARY outcome

Timeframe: 1 year

Population: patients withdrew

Function will be assessed using the The Short Form (18) Health Survey (SF-18). The SF-18is a 18-item questionnaire to assess health-related quality-of-life. Health concepts of physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Scoring: RAND scoring is composed of precoded numeric values that are recoded per RAND scoring key and each item is scored on a 0-100 range so that the lowest and highest possible scores are 0 and 100. Scores represent the percentage of total possible score achieved. In the second part of the scoring key, items are averaged together to create each scale allowing the scale to represent the average for all items in the scale that was answered.

Outcome measures

Outcome measures
Measure	Placebo n=3 Participants Placebo	Drug Cohort n=2 Participants Fluoxetine 20mg/day
Function	78.40 units on a scale Standard Deviation 40.11	83.22 units on a scale Standard Deviation 10.65

SECONDARY outcome

Timeframe: 1 year

Function will be assessed using the Barthel Index. The Barthel Index is a scale used to determine functional status, measuring performance in activities of daily living. Values assigned to each item are based on a time and amount of actual assistance required if a patient is unable to perform the activity. It can also be used to understand the course of rehabilitation and show how much progress toward independence has occurred. If there is a lack of improvement in the Barthel Index after a reasonable period of treatment, it indicates poor potential for rehab. The total score is not as significant or meaningful as the breakdown into individual items, but rather indicates where deficiencies are. A minimum score is 0, and a maximum score is 100. A patient scoring 0 is incontinent and cannot perform daily tasks independently. A patient scoring 100 is continent and able to perform daily tasks independently.

Outcome measures

Outcome measures
Measure	Placebo n=3 Participants Placebo	Drug Cohort n=2 Participants Fluoxetine 20mg/day
Function	100 units on a scale Standard Deviation 0	100 units on a scale Standard Deviation 0

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Drug Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=4 participants at risk Placebo	Drug Cohort n=4 participants at risk Fluoxetine 20mg/day
Surgical and medical procedures Meningitis	25.0% 1/4 • Number of events 1 • from enrollment until end of follow-up, an average of 1 year	0.00% 0/4 • from enrollment until end of follow-up, an average of 1 year

Other adverse events

Adverse event data not reported

Additional Information

Professor of Neurological Surgery

University of Washington

Phone: 2067449330

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place