Fluoxetine for Motor Recovery After Acute Intracerebral Hemorrhage

• Status: Terminated
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blind, placebo-controlled, multicenter clinical trial that will be carried out in Mexico. The purpose of this study is to test whether a 3-month treatment with fluoxetine enhances motor recovery in non-depressed patients with acute intracerebral hemorrhage.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidad Autónoma de Aguascalientes
• Treatments: Fluoxetine

Criteria

Inclusion Criteria:

• Patients who had an acute intracerebral hemorrhage within the past 10 days causing hemiparesis or hemiplegia

• Fugl-Meyer motor scale (FMMS) scores of 55 or less

• Written informed consent for participation in the trial

Exclusion Criteria:

• Severe post-stroke disability (National Institutes of Health stroke scale [NIHSS] score >20)

• Premorbid disability, evidenced by residual motor deficit from a previous stroke

• Comprehension deficit or severe aphasia

• Previous diagnosis of depression or one of the following:

• Hospital Anxiety and Depression Scale score ≥11 points

• Taking antidepressant drugs two weeks before inclusion

• Taking neuroleptic drugs or benzodiazepines two weeks before inclusion

• Other major diseases with life expectancy less than 3 months.