Preventative Treatment of Depression in Survivors of Aneurysmal Subarachnoid Hemorrhage
Overview
- Phase
- Phase 2
- Intervention
- Fluoxetine
- Conditions
- Stroke Hemorrhagic
- Sponsor
- University of Washington
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Depression
- Status
- Completed
- Last Updated
- 8 months ago
Overview
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.
Investigators
Michael Robert Levitt, MD
Assistant Professor, School of Medicine, Neurological Surgery
University of Washington
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.
Arms & Interventions
Treatment
Patients randomized to the fluoxetine treatment group will be initially prescribed fluoxetine 20mg/day for a period of one year.
Intervention: Fluoxetine
Placebo
Patients randomized to the placebo group will be initially prescribed placebo 20mg/day for a period of one year.
Intervention: Placebo
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Anxiety(1 year)
- Fatigue(1 year)
- Healthcare Utilization(1 year)
- Social Support(1 year)
- Sleep Disturbance(1 year)
- Function(1 year)