<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03826875</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00002718</org_study_id>
    <nct_id>NCT03826875</nct_id>
  </id_info>
  <brief_title>Poststroke Depression in Hemorrhagic Stroke</brief_title>
  <official_title>Preventative Treatment of Depression in Survivors of Aneurysmal Subarachnoid Hemorrhage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A double-blinded placebo-controlled randomized trial to evaluate the effect of preventative&#xD;
      treatment of depression in survivors of aneurysmal subarachnoid hemorrhage (aSAH), a type of&#xD;
      stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients who suffered aneurysmal subarachnoid hemorrhage will be randomly assigned either an&#xD;
      oral antidepressant or placebo and evaluated for the preventative treatment of depression and&#xD;
      health-related quality-of-life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Anticipated">November 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 25, 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>double-blinded placebo-controlled randomized trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Depression</measure>
    <time_frame>1 year</time_frame>
    <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, &gt;23 very severe depression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depression</measure>
    <time_frame>1 year</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>1 year</time_frame>
    <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 &lt;17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>1 year</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare Utilization</measure>
    <time_frame>1 year</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Support</measure>
    <time_frame>1 year</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Disturbance</measure>
    <time_frame>1 year</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Function</measure>
    <time_frame>1 year</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Function</measure>
    <time_frame>1 year</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">224</enrollment>
  <condition>Stroke Hemorrhagic</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to the fluoxetine treatment group will be initially prescribed fluoxetine 20mg/day for a period of one year.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients randomized to the placebo group will be initially prescribed placebo 20mg/day for a period of one year.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluoxetine</intervention_name>
    <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</description>
    <arm_group_label>Treatment</arm_group_label>
    <other_name>Prozac</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <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</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients 18-85 years of age aged 18 years and older will be included.&#xD;
&#xD;
        Patients admitted for subarachnoid hemorrhage from a ruptured cerebral aneurysm will be&#xD;
        included.&#xD;
&#xD;
        Only patients who provide informed consent will be included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Non-English speaking patients will be excluded.&#xD;
&#xD;
        Patients currently receiving therapy for depression or related mental health diagnoses&#xD;
        before admission will be excluded.&#xD;
&#xD;
        Patients with medical contraindications to fluoxetine therapy will be excluded.&#xD;
&#xD;
        Pregnant patients or patients considering pregnancy during the trial period at the time of&#xD;
        consent will be excluded.&#xD;
&#xD;
        Patients with active psychosis will be excluded.&#xD;
&#xD;
        Patients who are incarcerated or in police custody will be excluded.&#xD;
&#xD;
        Patients with a comorbidity or cognitive impairment (as determined by a&#xD;
        recruiter-administered Montreal Cognitive Assessment; Patients scoring &gt;26 are considered&#xD;
        of appropriate cognitive function for consent) that precludes informed consent and&#xD;
        participation in the research interviews will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Levitt, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Do Lim</last_name>
    <phone>206-744-9330</phone>
    <email>dolim@uw.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Harborview Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Do Lim, BS</last_name>
      <phone>206-744-9330</phone>
      <email>dolim@uw.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>October 31, 2022</last_update_submitted>
  <last_update_submitted_qc>October 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Michael Robert Levitt, MD</investigator_full_name>
    <investigator_title>Assistant Professor, School of Medicine, Neurological Surgery</investigator_title>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>hemorrhagic stroke</keyword>
  <keyword>subarachnoid hemorrhage</keyword>
  <keyword>depression</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Subarachnoid Hemorrhage</mesh_term>
    <mesh_term>Hemorrhagic Stroke</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluoxetine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No individual participant data provided.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03826875
org study id: STUDY00002718
nct id: NCT03826875
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: double-blinded placebo-controlled randomized trial
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Depression
time frame: 1 year
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.
measure: Depression
time frame: 1 year
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.
measure: Anxiety
time frame: 1 year
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.
measure: Fatigue
time frame: 1 year
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.
measure: Healthcare Utilization
time frame: 1 year
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.
measure: Social Support
time frame: 1 year
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.
measure: Sleep Disturbance
time frame: 1 year
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.
measure: Function
time frame: 1 year
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.
measure: Function
time frame: 1 year
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.
arm group label: Treatment
arm group type: Experimental
description: Patients randomized to the fluoxetine treatment group will be initially prescribed fluoxetine 20mg/day for a period of one year.
arm group label: Placebo
arm group type: Placebo Comparator
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: Fluoxetine
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
arm group label: Treatment
other name: Prozac
intervention type: Drug
intervention name: Placebo
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
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Michael Levitt, MD
role: Principal Investigator
affiliation: University of Washington
last name: Do Lim
phone: 206-744-9330
email: dolim@uw.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Michael Robert Levitt, MD
investigator title: Assistant Professor, School of Medicine, Neurological Surgery
mesh term: Stroke
mesh term: Subarachnoid Hemorrhage
mesh term: Hemorrhagic Stroke
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Fluoxetine
sharing ipd: No
ipd description: No individual participant data provided.