Depression, Stroke Hemorrhagic
Conditions
Keywords
stroke, hemorrhagic stroke, subarachnoid hemorrhage, depression
Brief summary
A double-blinded placebo-controlled randomized trial to evaluate the effect of preventative treatment of depression in survivors of aneurysmal subarachnoid hemorrhage (aSAH), a type of stroke.
Detailed description
Patients who suffered aneurysmal subarachnoid hemorrhage will be randomly assigned either an oral antidepressant or placebo and evaluated for the preventative treatment of depression and health-related quality-of-life.
Interventions
DRUGFluoxetine
Patients who suffered aneurysmal subarachnoid hemorrhage will be prescribed fluoxetine and evaluated for the preventative treatment of depression and health-related quality-of-life
DRUGPlacebo
Patients who suffered aneurysmal subarachnoid hemorrhage will be prescribed placebo and evaluated for the preventative treatment of depression and health-related quality-of-life
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
double-blinded placebo-controlled randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Patients 18-85 years of age aged 18 years and older will be included. Patients admitted for subarachnoid hemorrhage from a ruptured cerebral aneurysm will be included. Only patients who provide informed consent will be included.
Exclusion criteria
Non-English speaking patients will be excluded. Patients currently receiving therapy for depression or related mental health diagnoses before admission will be excluded. Patients with medical contraindications to fluoxetine therapy will be excluded. Pregnant patients or patients considering pregnancy during the trial period at the time of consent will be excluded. Patients with active psychosis will be excluded. Patients who are incarcerated or in police custody will be excluded. Patients with a comorbidity or cognitive impairment (as determined by a recruiter-administered Montreal Cognitive Assessment; Patients scoring \>26 are considered of appropriate cognitive function for consent) that precludes informed consent and participation in the research interviews will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | 1 year | 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. |
| Healthcare Utilization | 1 year | 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. |
| Anxiety | 1 year | 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. |
| Sleep Disturbance | 1 year | (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. |
| Function | 1 year | 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. |
| Social Support | 1 year | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo | 4 |
| Drug Cohort Fluoxetine 20mg/day | 4 |
| Total | 8 |
Baseline characteristics
| Characteristic | Drug Cohort | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 60.25 year STANDARD_DEVIATION 9.74 | 50.75 year STANDARD_DEVIATION 14.08 | 55.50 year STANDARD_DEVIATION 12.31 |
| Baseline Hamilton Rating Scale for Depression (HAM-D) | 8.67 Score STANDARD_DEVIATION 6.81 | 11.5 Score STANDARD_DEVIATION 10.61 | 9.80 Score STANDARD_DEVIATION 7.33 |
| Baseline Patient Health Questionnaire (PHQ-9) Depression | 9.5 Score STANDARD_DEVIATION 6.81 | 10.25 Score STANDARD_DEVIATION 8.77 | 9.88 Score STANDARD_DEVIATION 7.28 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 4 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 1 / 4 | 0 / 4 |
Outcome results
Primary
Depression
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.
Time frame: 1 year
Population: Patients withdrew
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Depression | 12.33 units on a scale | Standard Deviation 3.21 |
| Drug Cohort | Depression | 6 units on a scale | Standard Deviation 5.66 |
Primary
Depression
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
Time frame: 1 year
Population: patients withdrew
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Depression | 5.67 units on a scale | Standard Deviation 2.08 |
| Drug Cohort | Depression | 5.00 units on a scale | Standard Deviation 7.07 |
Secondary
Anxiety
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.
Time frame: 1 year
Population: patients withdrew
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Anxiety | 8.00 units on a scale | Standard Deviation 3.61 |
| Drug Cohort | Anxiety | 9.50 units on a scale | Standard Deviation 6.36 |
Secondary
Fatigue
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.
Time frame: 1 year
Population: patients withdrew
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Fatigue | 2.71 units on a scale | Standard Deviation 1.07 |
| Drug Cohort | Fatigue | 1.39 units on a scale | Standard Deviation 0.08 |
Secondary
Function
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.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Function | 100 units on a scale | Standard Deviation 0 |
| Drug Cohort | Function | 100 units on a scale | Standard Deviation 0 |
Secondary
Function
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.
Time frame: 1 year
Population: patients withdrew
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Function | 78.40 units on a scale | Standard Deviation 40.11 |
| Drug Cohort | Function | 83.22 units on a scale | Standard Deviation 10.65 |
Secondary
Healthcare Utilization
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.
Time frame: 1 year
Population: participants withdrew
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Healthcare Utilization | 5.67 units on a scale | Standard Deviation 8.46 |
| Drug Cohort | Healthcare Utilization | 23 units on a scale | Standard Deviation 32.53 |
Secondary
Sleep Disturbance
(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.
Time frame: 1 year
Population: patients withdrew
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Sleep Disturbance | 48.97 T-score | Standard Deviation 9.35 |
| Drug Cohort | Sleep Disturbance | 44.85 T-score | Standard Deviation 0.92 |
Secondary
Social Support
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
Time frame: 1 year
Population: patients withdrew
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Social Support | 6.80 units on a scale | Standard Deviation 0.34 |
| Drug Cohort | Social Support | 4.75 units on a scale | Standard Deviation 0.95 |