Back to resultsPoststroke Depression in Hemorrhagic Stroke
Primary Purpose
Stroke Hemorrhagic, Depression
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fluoxetine
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Stroke Hemorrhagic focused on measuring stroke, hemorrhagic stroke, subarachnoid hemorrhage, depression
Eligibility Criteria
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.
Sites / Locations
- Harborview Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment
Placebo
Arm Description
Patients randomized to the fluoxetine treatment group will be initially prescribed fluoxetine 20mg/day for a period of one year.
Patients randomized to the placebo group will be initially prescribed placebo 20mg/day for a period of one year.
Outcomes
Primary Outcome Measures
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 diagnosis severe depression. Examining a different symptom or aspect of depression such as mood, guilty feelings, suicidal ideation, etc.. The first 17 questions are used for scoring. A total score is tallied from 1-17 and if the score totals: 0-7 normal, 8-13 mild depression, 14-18 moderate depression, 19-22 severe depression, >23 very severe depression.
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 where score totals of: 1-4 minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression.
Secondary Outcome Measures
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.
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.
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.
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. Scoring: Total scale average will be taken whereas for each subscale the average will be taken as: 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. Mean scale score ranging from 1-2.9 is considered low support; a score of 3-5 is considered moderate support; a score from 5.1. to 7 is considered high support.
Sleep Disturbance
Sleep Disturbance will be assessed using the Patient-Reported Outcomes Measurement Information System-Sleep Disturbance scale (PROMIS-Sleep Disturbance). PROMIS is a sleep disturbance scale used to assess pure domain of sleep disturbance. 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: Total raw score for a measure will be converted according to PROMIS Score Conversion table and it 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 deviant 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
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.
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. Also is able to be used to understand the course of rehabilitation and show how much progress toward independence as occurred. If there is a lack of improvement in the Barthel Index after a reasonable period of treatment it indicates poor potential for rehab. Scoring: A patient scoring 100 is continent and able to do daily tasks by themselves. Total score is not as significant or meaningful as the breakdown into individual items but rather indicate where deficiencies are.
Full Information
NCT ID
NCT03826875
First Posted
January 28, 2019
Last Updated
October 31, 2022
Sponsor
University of Washington
1. Study Identification
Unique Protocol Identification Number
NCT03826875
Brief Title
Poststroke Depression in Hemorrhagic Stroke
Official Title
Preventative Treatment of Depression in Survivors of Aneurysmal Subarachnoid Hemorrhage
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
February 25, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Hemorrhagic, Depression
Keywords
stroke, hemorrhagic stroke, subarachnoid hemorrhage, depression
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
double-blinded placebo-controlled randomized trial
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
224 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Patients randomized to the fluoxetine treatment group will be initially prescribed fluoxetine 20mg/day for a period of one year.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients randomized to the placebo group will be initially prescribed placebo 20mg/day for a period of one year.
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Other Intervention Name(s)
Prozac
Intervention Description
Patients who suffered aneurysmal subarachnoid hemorrhage will be prescribed fluoxetine and evaluated for the preventative treatment of depression and health-related quality-of-life
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients who suffered aneurysmal subarachnoid hemorrhage will be prescribed placebo and evaluated for the preventative treatment of depression and health-related quality-of-life
Primary Outcome Measure Information:
Title
Depression
Description
Depression will be assessed using the Hamilton Rating Scale for Depression (HAM-D). The HAM-D is a 21 item questionnaire to treat and diagnosis severe depression. Examining a different symptom or aspect of depression such as mood, guilty feelings, suicidal ideation, etc.. The first 17 questions are used for scoring. A total score is tallied from 1-17 and if the score totals: 0-7 normal, 8-13 mild depression, 14-18 moderate depression, 19-22 severe depression, >23 very severe depression.
Time Frame
1 year
Title
Depression
Description
Depression will be assessed using the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a 9 item questionnaire to treat and diagnose depression where score totals of: 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
Secondary Outcome Measure Information:
Title
Anxiety
Description
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
Title
Fatigue
Description
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.
Time Frame
1 year
Title
Healthcare Utilization
Description
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.
Time Frame
1 year
Title
Social Support
Description
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. Scoring: Total scale average will be taken whereas for each subscale the average will be taken as: 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. Mean scale score ranging from 1-2.9 is considered low support; a score of 3-5 is considered moderate support; a score from 5.1. to 7 is considered high support.
Time Frame
1 year
Title
Sleep Disturbance
Description
Sleep Disturbance will be assessed using the Patient-Reported Outcomes Measurement Information System-Sleep Disturbance scale (PROMIS-Sleep Disturbance). PROMIS is a sleep disturbance scale used to assess pure domain of sleep disturbance. 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: Total raw score for a measure will be converted according to PROMIS Score Conversion table and it 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 deviant 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
Title
Function
Description
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
Title
Function
Description
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. Also is able to be used to understand the course of rehabilitation and show how much progress toward independence as occurred. If there is a lack of improvement in the Barthel Index after a reasonable period of treatment it indicates poor potential for rehab. Scoring: A patient scoring 100 is continent and able to do daily tasks by themselves. Total score is not as significant or meaningful as the breakdown into individual items but rather indicate where deficiencies are.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Do Lim
Phone
206-744-9330
Email
dolim@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Levitt, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Do Lim, BS
Phone
206-744-9330
Email
dolim@uw.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data provided.
Learn more about this trial
Poststroke Depression in Hemorrhagic Stroke
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