Clinical trial NCT01674868: Fluoxetine for Motor, Aphasia, and Neglect Recovery After Ischemic Stroke
Official title: Pilot RCT of Fluoxetine vs Placebo to Treat Motor, Language and Unilateral Neglect After Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stroke
Keywords: stroke
recovery
fluoxetine
aphasia
neglect
motor
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2012-08-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Fugl-Meyer Motor Scale (FMMS)
timeFrame: baseline to 90 days
measure: Fugl-Meyer Motor Scale (FMMS)
timeFrame: baseline to 180 days
Secondary outcomes:
measure: Western Aphasia Battery
timeFrame: baseline to 90 days
measure: Behavioral Inattention Test (BIT)
timeFrame: baseline to 90 days
measure: Behavioral Inattention Test (BIT)
timeFrame: baseline to 180 days
measure: Functional Independence Measure
timeFrame: baseline to discharge
measure: Fatigue Severity Scale
timeFrame: baseline to 90 days
measure: Beck Depression Inventory
timeFrame: baseline to 90 days
measure: Western Aphasia Battery
timeFrame: baseline to 180 days
measure: Beck Depression Inventory
timeFrame: baseline to 180 days
measure: Fatigue Severity Scale
timeFrame: baseline to 180 days
measure: modified Rankin Scale
timeFrame: baseline to 90 days
measure: modified Rankin Scale
timeFrame: baseline to 180 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
References: