Fluoxetine for Motor Recovery After Acute Intracerebral Hemorrhage

Phase 3

Terminated

• Conditions: Intracerebral Hemorrhage; Motor Impairment
• Interventions: Drug: Placebo; Drug: Fluoxetine

• Registration Number: NCT01737541
• Lead Sponsor: Universidad Autónoma de Aguascalientes

Brief Summary

This is a randomized, double-blind, placebo-controlled, multicenter clinical trial that will be carried out in Mexico. The purpose of this study is to test whether a 3-month treatment with fluoxetine enhances motor recovery in non-depressed patients with acute intracerebral hemorrhage.

Detailed Description

Spontaneous, nontraumatic intracerebral hemorrhage (ICH) is a subtype of stroke that causes a great amount of disability, economic and social burden. This is particularly true in developing countries where it accounts for between 20% and 50% of all strokes. Pharmacological and surgical interventions have been attempted to diminish the mortality and disability derived from ICH, with unsuccessful results. Recently the use of Fluoxetine in addition to physical rehabilitation has been proven useful to improve motor recovery from cerebral infarct. The purpose of this study is to test whether a 3-month treatment with fluoxetine enhances motor recovery in non-depressed patients with acute intracerebral hemorrhage.

This is a randomized, double-blind, placebo-controlled, multicenter clinical trial. This trial will recruit 86 patients with intracerebral hemorrhage of both sexes, ages \>18 years, from four Mexican hospitals. The patients will receive either 20mg of fluoxetine or a placebo once daily for 90 days. The primary outcome is the mean change in Fugl-Meyer Motor Scale score between inclusion (day 0) and day 90. The secondary outcomes will be changes in Barthel Index, Modified Rankin scale and National Institutes of Health (NIH) Stroke Scale. The outcomes will be measured at day 45±7days and at day 90, for a total of four visits with each subject (at screening and at 0, 45 and 90days).

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-21
• Study First Submitted QC: 2012-11-26
• Study First Posted: 2012-11-29
• Status Verified: 2014-08
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Last Update Submitted: 2014-08-20
• Last Update Posted: 2014-08-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Patients who had an acute intracerebral hemorrhage within the past 10 days causing hemiparesis or hemiplegia
• Fugl-Meyer motor scale (FMMS) scores of 55 or less
• Written informed consent for participation in the trial

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Exclusion Criteria

• Severe post-stroke disability (National Institutes of Health stroke scale [NIHSS] score >20)

• Premorbid disability, evidenced by residual motor deficit from a previous stroke

• Comprehension deficit or severe aphasia

• Previous diagnosis of depression or one of the following:

  • Hospital Anxiety and Depression Scale score ≥11 points
  • Taking antidepressant drugs two weeks before inclusion

• Taking neuroleptic drugs or benzodiazepines two weeks before inclusion

• Other major diseases with life expectancy less than 3 months.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	per os daily
Fluoxetine	Fluoxetine	fluoxetine per os 20 mg daily

Primary Outcome Measures

Name	Time	Method
Fugl Meyer Motor Scale score	Baseline and 90 days	Change from Baseline in Fugl Meyer Motor Scale score at 90 days

Secondary Outcome Measures

Name	Time	Method
NIH Stroke Scale	Baseline and 90 days	Change from Baseline in NIH Stroke Scale at 90 days
Barthel Index	Baseline and 90 days	Change from Baseline in Barthel Index at 90 days
modified Rankin Scale	Baseline and 90 days	Change from Baseline in modified Rankin Scale at 90 days

Trial Locations

Locations (4)

Hospital General de Zona #1; 🇲🇽 Aguascalientes, Mexico

Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde; 🇲🇽 Guadalajara, Jalisco, Mexico

Instituto Nacional de Neurología y Neurocirugía; 🇲🇽 Mexico City, Mexico

Hospital Regional de Alta Especialidad Dr. Juan Graham Casasus; 🇲🇽 Villahermosa, Tabasco, Mexico