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. 2019 Nov 26;2019(11):CD009286. doi: 10.1002/14651858.CD009286.pub3

Levitt 2019.

Trial name or title Depression in haemorrhagic stroke
Methods Study type: interventional (clinical trial)
Estimated enrolment: 224 participants
Allocation: randomised
Intervention model: parallel assignment
Intervention model description: double‐blinded placebo‐controlled randomised trial
Masking: triple (participant, care provider, investigator)
Primary purpose: prevention
Participants Country: USA
Setting: inpatient
Inclusion criteria:
  • Age 18 to 85 years

  • Subarachnoid haemorrhage from a ruptured cerebral aneurysm

  • Consent


Exclusion criteria:
  • Non‐English speaking

  • Taking therapy for depression or related mental health diagnoses before admission

  • Medical contraindications to fluoxetine therapy

  • Pregnancy or considering getting pregnant during the trial period at the time of consent.

  • Active psychosis

  • Incarcerated or in police custody

  • Comorbidity or a score > 26 on the Montreal Cognitive Assessment

Interventions Experimental: fluoxetine 20 mg/day for a period of 1 year
Comparator: placebo 20 mg/day for a period of 1 year
Outcomes Primary outcomes at 1 year
  • Depression measured using HAM‐D

  • Depression measured using PHQ‐9


Secondary outcomes at 1 year:
  • Anxiety measured using Hamilton Rating Scale for Anxiety

  • Fatigue measured using Fatigue Severity Scale

  • Healthcare utilization measured using Self‐Report Health Service Utilization and Medication Use

  • Social support measured using Multidimensional Scale of Perceived Social Support (MSPSS)

Starting date 1 March 2019
Contact information Cory M Kelly 206‐685‐3043 kellycm@neurosurgery.washington.edu
Notes NCT03826875