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

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ClinicalTrials.gov Identifier: NCT01674868
Recruitment Status : Withdrawn (unable to find patients meeting inclusion/exclusion criteria)
First Posted : August 29, 2012
Last Update Posted : June 16, 2015
Sponsor:
Information provided by (Responsible Party):
Randie Black-Schaffer MD, Spaulding Rehabilitation Hospital

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : April 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke
Drug Information available for: Fluoxetine

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Fugl-Meyer Motor Scale (FMMS) [ Time Frame: baseline to 90 days ]
    change in FMMS score

  2. Fugl-Meyer Motor Scale (FMMS) [ Time Frame: baseline to 180 days ]
    change in FMMS


Secondary Outcome Measures :
  1. Western Aphasia Battery [ Time Frame: baseline to 90 days ]
    change in Western Aphasia Quotient

  2. Behavioral Inattention Test (BIT) [ Time Frame: baseline to 90 days ]
    change in BIT

  3. Behavioral Inattention Test (BIT) [ Time Frame: baseline to 180 days ]
    change in BIT

  4. Functional Independence Measure [ Time Frame: baseline to discharge ]
    change in FIM

  5. Fatigue Severity Scale [ Time Frame: baseline to 90 days ]
  6. Beck Depression Inventory [ Time Frame: baseline to 90 days ]
  7. Western Aphasia Battery [ Time Frame: baseline to 180 days ]
    change in Western Aphasia Quotient

  8. Beck Depression Inventory [ Time Frame: baseline to 180 days ]
  9. Fatigue Severity Scale [ Time Frame: baseline to 180 days ]
  10. modified Rankin Scale [ Time Frame: baseline to 90 days ]
  11. modified Rankin Scale [ Time Frame: baseline to 180 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01674868


Locations
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United States, Massachusetts
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
More Information
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Responsible Party: Randie Black-Schaffer MD, Medical Director, Stroke Program, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01674868    
Other Study ID Numbers: FLAN SpauldingRH
First Posted: August 29, 2012    Key Record Dates
Last Update Posted: June 16, 2015
Last Verified: June 2015
Keywords provided by Randie Black-Schaffer MD, Spaulding Rehabilitation Hospital:
stroke
recovery
fluoxetine
 aphasia
neglect
motor
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors