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

Withdrawn

Phase N/A Results N/A

Trial Description

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.

Trial Stopped: unable to find patients meeting inclusion/exclusion criteria

Conditions

Interventions

  • Fluoxetine (ProzacĀ®)Drug
    Intervention Desc: 20 mg daily for 90 days starting day 5-10 after stroke.
    ARM 1: Kind: Experimental
    Label: Fluoxetine
    Description: Subjects will take 20 mg fluoxetine daily for 90 days starting at day 5-10 after stroke.
  • Placebo Drug
    Intervention Desc: subjects will take one pill po daily for 90 days.
    ARM 1: Kind: Experimental
    Label: placebo
    Description: Subjects will take one pill daily for 90 days.

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer Motor Scale (FMMS) baseline to 45 days No
Secondary Western Aphasia Battery baseline to 45 days No
Secondary Behavioral Inattention Test (BIT) baseline to 45 days No
Secondary Functional Independence Measure baseline to discharge No
Secondary Fatigue Severity Scale baseline to 90 days No
Secondary Beck Depression Inventory baseline to 90 days No
Secondary modified Rankin Scale baseline to 90 days No

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