Poststroke Depression in Hemorrhagic Stroke
Purpose
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.
Conditions
- Stroke Hemorrhagic
- Depression
Eligibility
- Eligible Ages
- Between 18 Years and 85 Years
- Eligible Genders
- All
- Accepts 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- double-blinded placebo-controlled randomized trial
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment |
Patients randomized to the fluoxetine treatment group will be initially prescribed fluoxetine 20mg/day for a period of one year. |
|
|
Placebo Comparator Placebo |
Patients randomized to the placebo group will be initially prescribed placebo 20mg/day for a period of one year. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- University of Washington
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.
