Fluoxetine for Motor Recovery After Acute Intracerebral Hemorrhage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-08-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Intracerebral Hemorrhage Motor Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fluoxetine

fluoxetine per os 20 mg daily

Group Type EXPERIMENTAL

Fluoxetine

Intervention Type DRUG

Placebo

per os daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Fluoxetine

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Fluoxac

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No