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

Stroke Clinical Trial

— FLAN  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01674868
• Other study ID #: FLAN SpauldingRH
• Status: Withdrawn
• Phase: N/A
• First received: August 24, 2012
• Last updated: June 14, 2015
• Start date: April 2013
• Est. completion date: December 2015

Study information

• Verified date: June 2015
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• fluoxetine
20 mg daily for 90 days starting day 5-10 after stroke.
• placebo
subjects will take one pill po daily for 90 days.

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Motor Scale (FMMS)	change in FMMS score	baseline to 90 days	No
Primary	Fugl-Meyer Motor Scale (FMMS)	change in FMMS	baseline to 180 days	No
Secondary	Western Aphasia Battery	change in Western Aphasia Quotient	baseline to 90 days	No
Secondary	Behavioral Inattention Test (BIT)	change in BIT	baseline to 90 days	No
Secondary	Behavioral Inattention Test (BIT)	change in BIT	baseline to 180 days	No
Secondary	Functional Independence Measure	change in FIM	baseline to discharge	No
Secondary	Fatigue Severity Scale		baseline to 90 days	No
Secondary	Beck Depression Inventory		baseline to 90 days	No
Secondary	Western Aphasia Battery	change in Western Aphasia Quotient	baseline to 180 days	No
Secondary	Beck Depression Inventory		baseline to 180 days	No
Secondary	Fatigue Severity Scale		baseline to 180 days	No
Secondary	modified Rankin Scale		baseline to 90 days	No
Secondary	modified Rankin Scale		baseline to 180 days	No