Stroke HemorrhagicPhase 2NCT03826875
Poststroke Depression in Hemorrhagic Stroke
A Phase 2 study testing Fluoxetine in people with Stroke Hemorrhagic and Depression, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke Hemorrhagic, Depression
- What is being tested?
- Fluoxetine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 7 May 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: Preventative Treatment of Depression in Survivors of Aneurysmal Subarachnoid Hemorrhage
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.
Read the 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.
- Conditions
- Stroke Hemorrhagic, Depression
- Being tested
- Fluoxetine, Placebo
- Keywords
- stroke, hemorrhagic stroke, subarachnoid hemorrhage, depression
- Medical subject headings
- Hemorrhagic Stroke, Depression, Stroke, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoxetineDrug
Also called Prozac
Patients who suffered aneurysmal subarachnoid hemorrhage will be prescribed fluoxetine and evaluated for the preventative treatment of depression and health-related quality-of-life
PlaceboDrug
Patients who suffered aneurysmal subarachnoid hemorrhage will be prescribed placebo and evaluated for the preventative treatment of depression and health-related quality-of-life
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients randomized to the fluoxetine treatment group will be initially prescribed fluoxetine 20mg/day for a period of one year. Receives: Drug: Fluoxetine |
| Placebo | Placebo comparator | Patients randomized to the placebo group will be initially prescribed placebo 20mg/day for a period of one year. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
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
Measured: 1 year
Secondary outcomes (7)
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start1 Mar 2019
- Primary completion7 May 2025
- Study completion7 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stroke HemorrhagicStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blinded placebo-controlled randomized trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Robert Levitt, MD, University of Washington
- Investigators
- Michael Levitt, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826875
- Sponsor's protocol ID
- STUDY00002718
- Status last verified
- Jul 2025
- First submitted
- 28 Jan 2019
- Last updated
- 6 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data provided.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventative Treatment of Depression in Survivors of Aneurysmal Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT03826875
- Acronym / sponsor ID
- STUDY00002718
- Conditions
- Stroke Hemorrhagic, Depression
- Keywords
- stroke, hemorrhagic stroke, subarachnoid hemorrhage, depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 7 May 2025 (actual)
- Study completion
- 7 May 2025 (actual)
- First posted
- 1 Feb 2019 (actual)
- Results
- Posted 6 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- double-blinded placebo-controlled randomized trial
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: FluoxetinePatients randomized to the fluoxetine treatment group will be initially prescribed fluoxetine 20mg/day for a period of one year. |
| Placebo | Placebo comparator | Drug: PlaceboPatients randomized to the placebo group will be initially prescribed placebo 20mg/day for a period of one year. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluoxetineAlso: ProzacPatients who suffered aneurysmal subarachnoid hemorrhage will be prescribed fluoxetine and evaluated for the preventative treatment of depression and health-related quality-of-life | Drug | Treatment |
| PlaceboPatients who suffered aneurysmal subarachnoid hemorrhage will be prescribed placebo and evaluated for the preventative treatment of depression and health-related quality-of-life | Drug | Placebo |
Primary outcome
Depression
Time frame: 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.
Depression
Time frame: 1 year
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
7 secondary outcomes
Anxiety
Time frame: 1 year
Fatigue
Time frame: 1 year
Healthcare Utilization
Time frame: 1 year
Social Support
Time frame: 1 year
Sleep Disturbance
Time frame: 1 year
Function
Time frame: 1 year
Function
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No individual participant data provided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Levitt, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluoxetine in people with Stroke Hemorrhagic and Depression, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.