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

NCT01674868 | Withdrawn

• 1 other identifier: FLAN SpauldingRH
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; recovery; fluoxetine; aphasia; neglect; motor

Outcome Measures

Primary Outcomes (2)

• Fugl-Meyer Motor Scale (FMMS)

  change in FMMS score

  baseline to 90 days

• Fugl-Meyer Motor Scale (FMMS)

  change in FMMS

  baseline to 180 days

Secondary Outcomes (11)

• Western Aphasia Battery

  baseline to 90 days

• Behavioral Inattention Test (BIT)

  baseline to 90 days

• Behavioral Inattention Test (BIT)

  baseline to 180 days

• Functional Independence Measure

  baseline to discharge

• Fatigue Severity Scale

  baseline to 90 days

Study Arms (2)

Fluoxetine

EXPERIMENTAL

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

Drug: fluoxetine

placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

fluoxetine DRUG

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

Fluoxetine

placebo DRUG

subjects will take one pill po daily for 90 days.

placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Stroke; Aphasia

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Stroke Program

Study Record Dates

• First Submitted: August 24, 2012
• First Posted: August 29, 2012
• Study Start: April 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 16, 2015

Record last verified: 2015-06

Locations

US (1)