Fluoxetine for Motor, Aphasia, and Neglect Recovery After Ischemic Stroke

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Stroke

In brief

This pilot study will recruit 25 subjects to assess the feasibility of replicating the FLAME study (Chollet, et al. Lancet 2011), a randomized controlled trial (RCT) that assessed the effect of fluoxetine vs placebo on motor recovery after ischemic stroke, in an American sample of post-acute stroke patients. This trial will in addition examine the effect of treatment with fluoxetine versus placebo on concurrent deficits in language and hemispatial attention, as well as post-stroke fatigue and will evaluate the durability of observed effects. The results of this pilot trial will be used to develop power estimates for a larger trial and to evaluate recruitment and intervention completion rates for subjects in an American post-acute environment. There are two additional substudies: the first will use MRI to assess structural changes at the beginning and end of the intervention; the second will examine the relationship of serum biomarkers of inflammation to the intervention.

Key facts

Study ID

NCT01674868

Run by

Spaulding Rehabilitation Hospital

People needed

0

Starts

2013-04-01

Expected to finish

2015-12-01

Last updated by the study team

2015-06-16

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ischemic infarction within 15 days
• Admission NIHSS item 5 score equal to or >2 -Able to give informed consent, with surrogate consent acceptable-

You may not qualify if…

• Pre-stroke modified Rankin Scale score equal or .3
• Pregnant or lactating
• Taking an SSRI on admission to SRH
• Taking a medication likely to have adverse interaction with an SSRI
• Unable to return for follow-up testing days 90,180
• Concurrent medial condition likely to worsen patient's functional status over next 6 months
• Unable to competently participate in testing for 45min-2hrs with rest breaks
• for MRI substudy: contraindication to MRI

Where it is running

• Spaulding Rehabilitation Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.