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

Not Applicable

Withdrawn

• Conditions: Stroke
• Interventions: Drug: placebo; Drug: fluoxetine

• Registration Number: NCT01674868
• Lead Sponsor: Spaulding Rehabilitation Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-24
• Study First Submitted QC: 2012-08-28
• Study First Posted: 2012-08-29
• Study Start: 2013-04
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-14
• Last Update Posted: 2015-06-16
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	Subjects will take one pill daily for 90 days after stroke.
Fluoxetine	fluoxetine	Subjects will take 20 mg fluoxetine daily for 90 days after stroke

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Motor Scale (FMMS)	baseline to 180 days	change in FMMS

Secondary Outcome Measures

Name	Time	Method
modified Rankin Scale	baseline to 180 days
Western Aphasia Battery	baseline to 180 days	change in Western Aphasia Quotient
Behavioral Inattention Test (BIT)	baseline to 180 days	change in BIT
Functional Independence Measure	baseline to discharge	change in FIM
Beck Depression Inventory	baseline to 180 days
Fatigue Severity Scale	baseline to 180 days

Trial Locations

Locations (1)

Spaulding Rehabilitation Hospital; 🇺🇸 Boston, Massachusetts, United States