Preventing depression in patients after a hemorrhagic stroke
Preventative Treatment of Depression in Survivors of Aneurysmal Subarachnoid Hemorrhage
This study is testing if the antidepressant fluoxetine can help prevent depression in adults who have survived a specific type of brain bleed called aneurysmal subarachnoid hemorrhage.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 224 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT03826875 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of fluoxetine, an oral antidepressant, in preventing depression among survivors of aneurysmal subarachnoid hemorrhage (aSAH), a specific type of hemorrhagic stroke. Participants aged 18 to 85 will be randomly assigned to receive either fluoxetine or a placebo in a double-blinded manner. The study aims to assess the impact of this treatment on the development of depression and overall health-related quality of life in these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 who have experienced a ruptured cerebral aneurysm leading to subarachnoid hemorrhage.
Not a fit: Patients currently receiving treatment for depression or with certain medical contraindications to fluoxetine will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of depression in patients recovering from aSAH, improving their quality of life.
How similar studies have performed: Previous studies have shown promise in using antidepressants for post-stroke depression, making this approach both relevant and potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Seattle, Washington
- Harborview Medical Center — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Michael Levitt, MD — University of Washington
- Study coordinator: Do Lim
- Email: dolim@uw.edu
- Phone: 206-744-9330
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.