Fluoxetine for Motor Recovery After Acute Intracerebral Hemorrhage (FMRICH)

August 20, 2014 updated by: Juan Manuel Marquez-Romero, Universidad Autónoma de Aguascalientes

Fluoxetine for Motor Recovery After Acute Intracerebral Hemorrhage (FMRICH): a Randomised Placebo-controlled Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Aguascalientes, Mexico, 202301
        • Hospital General de Zona #1
      • Mexico City, Mexico, 14269
        • Instituto Nacional de Neurologia y Neurocirugia
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
    • Tabasco
      • Villahermosa, Tabasco, Mexico, 86126
        • Hospital Regional de Alta Especialidad Dr. Juan Graham Casasus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluoxetine
fluoxetine per os 20 mg daily
Drug: Fluoxetine
Other Names:
  • Fluoxac
Placebo Comparator: Placebo
per os daily
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl Meyer Motor Scale score
Time Frame: Baseline and 90 days
Change from Baseline in Fugl Meyer Motor Scale score at 90 days
Baseline and 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barthel Index
Time Frame: Baseline and 90 days
Change from Baseline in Barthel Index at 90 days
Baseline and 90 days
modified Rankin Scale
Time Frame: Baseline and 90 days
Change from Baseline in modified Rankin Scale at 90 days
Baseline and 90 days
NIH Stroke Scale
Time Frame: Baseline and 90 days
Change from Baseline in NIH Stroke Scale at 90 days
Baseline and 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autónoma de Aguascalientes

Investigators

  • Principal Investigator: Juan M Marquez-Romero, MD, Universidad Autónoma de Aguascalientes
  • Study Director: Angel A Arauz, PhD, Instituto Nacional de Neurologia y Neurocirugia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

November 21, 2012

First Submitted That Met QC Criteria

November 26, 2012

First Posted (Estimate)

November 29, 2012

Study Record Updates

Last Update Posted (Estimate)

August 22, 2014

Last Update Submitted That Met QC Criteria

August 20, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 83/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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