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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Stroke
• Intervention / Treatment: Drug: fluoxetine; Drug: placebo

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Spaulding Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Aphasia Battery	change in Western Aphasia Quotient	baseline to 90 days
Behavioral Inattention Test (BIT)	change in BIT	baseline to 90 days
Behavioral Inattention Test (BIT)	change in BIT	baseline to 180 days
Functional Independence Measure	change in FIM	baseline to discharge
Fatigue Severity Scale		baseline to 90 days
Beck Depression Inventory		baseline to 90 days
Western Aphasia Battery	change in Western Aphasia Quotient	baseline to 180 days
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

Collaborators and Investigators

• Sponsor: Spaulding Rehabilitation Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: August 24, 2012
• First Submitted That Met QC Criteria: August 28, 2012
• First Posted (Estimate): August 29, 2012

Study Record Updates

• Last Update Posted (Estimate): June 16, 2015
• Last Update Submitted That Met QC Criteria: June 14, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: stroke; recovery; motor; fluoxetine; aphasia; neglect
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Fluoxetine
• Other Study ID Numbers: FLAN SpauldingRH