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

Sponsor

Spaulding Rehabilitation Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01674868

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Drug: fluoxetine Drug: placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Pilot RCT of Fluoxetine vs Placebo to Treat Motor, Language and Unilateral Neglect After Ischemic Stroke

Study Start Date :

Apr 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fluoxetine Subjects will take 20 mg fluoxetine daily for 90 days after stroke	Drug: fluoxetine 20 mg daily for 90 days starting day 5-10 after stroke.
Placebo Comparator: placebo Subjects will take one pill daily for 90 days after stroke.	Drug: placebo subjects will take one pill po daily for 90 days.

Arm

Intervention/Treatment

Experimental: Fluoxetine

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

Drug: fluoxetine

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

Placebo Comparator: placebo

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

Drug: placebo

subjects will take one pill po daily for 90 days.

Outcome Measures

Primary Outcome Measures

Fugl-Meyer Motor Scale (FMMS) [baseline to 90 days]
change in FMMS score
Fugl-Meyer Motor Scale (FMMS) [baseline to 180 days]
change in FMMS

Secondary Outcome Measures

Western Aphasia Battery [baseline to 90 days]
change in Western Aphasia Quotient
Behavioral Inattention Test (BIT) [baseline to 90 days]
change in BIT
Behavioral Inattention Test (BIT) [baseline to 180 days]
change in BIT
Functional Independence Measure [baseline to discharge]
change in FIM
Fatigue Severity Scale [baseline to 90 days]
Beck Depression Inventory [baseline to 90 days]
Western Aphasia Battery [baseline to 180 days]
change in Western Aphasia Quotient
Beck Depression Inventory [baseline to 180 days]
Fatigue Severity Scale [baseline to 180 days]
modified Rankin Scale [baseline to 90 days]
modified Rankin Scale [baseline to 180 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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