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

NCT ID: NCT01674868

Last Updated: 2015-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-12-31

Brief Summary

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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

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fluoxetine

Subjects will take 20 mg fluoxetine daily for 90 days after stroke

Group Type EXPERIMENTAL

fluoxetine

Intervention Type DRUG

20 mg daily for 90 days starting day 5-10 after stroke.

placebo

Subjects will take one pill daily for 90 days after stroke.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

subjects will take one pill po daily for 90 days.

Interventions

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fluoxetine

20 mg daily for 90 days starting day 5-10 after stroke.

Intervention Type DRUG

placebo

subjects will take one pill po daily for 90 days.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spaulding Rehabilitation Hospital

OTHER

Sponsor Role lead

Responsible Party

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Randie Black-Schaffer MD

Medical Director, Stroke Program

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Spaulding Rehabilitation Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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FLAN SpauldingRH

Identifier Type: -

Identifier Source: org_study_id

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