Phase 2 N=8 Randomized Triple-blind Prevention

Poststroke Depression in Hemorrhagic Stroke

Stroke Hemorrhagic · Depression

Bottom Line

View on ClinicalTrials.gov: NCT03826875 ↗

Enrolled (actual)

Serious AEs

12.5%

Results posted

Aug 2025

Primary outcome: Primary: Depression — 12.33; 6 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Fluoxetine (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Washington
Primary completion: May 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Depression	5.67; 5.00	—
PRIMARY Depression	5.67; 5.00	—
SECONDARY Anxiety	8.00; 9.50	—
SECONDARY Fatigue	2.71; 1.39	—
SECONDARY Healthcare Utilization	5.67; 23	—
SECONDARY Social Support	6.80; 4.75	—
SECONDARY Sleep Disturbance	48.97; 44.85	—
SECONDARY Function	100; 100	—
SECONDARY Function	100; 100	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03826875). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.