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Open Access Study protocol

Fluoxetine for motor recovery after acute intracerebral hemorrhage (FMRICH): study protocol for a randomized, double-blind, placebo-controlled, multicenter trial

Juan Manuel Marquez-Romero12*, Antonio Arauz2, José Luis Ruiz-Sandoval3, Erick de la Cruz-Estrada4, Maria Raquel Huerta-Franco5, Gerónimo Aguayo-Leytte6, Angélica Ruiz-Franco2 and Humberto Silos2

Author Affiliations

1 Centro de Ciencias de la Salud, Universidad Autónoma de Aguascalientes, Av. Universidad # 940, Ciudad Universitaria, Aguascalientes, 20131, Mexico

2 Stroke Clinic, Instituto Nacional de Neurología y Neurocirugía “MVS”, Av. Insurgentes Sur # 3877, Col. La Fama, Mexico City, 14269, Mexico

3 Hospital Civil de Guadalajara “Fray Antonio Alcalde”. Hospital 278, Col. El Retiro, Torre de Especialidades, 8vo. piso, Universidad de Guadalajara Guadalajara, Jalisco, 44280, Mexico

4 Hospital De Alta Especialidad “Dr. Juan Graham Casasus”. Carretera a la Isla SN. Col. Miguel Hidalgo, Villahermosa, Tabasco, Mexico

5 Department of Applied Sciences to Work, Health Science Division, University of Guanajuato, 37320 Leon, Guanajuato, Mexico

6 Centenario Hospital “Miguel Hidalgo”, Galeana Sur 465. Col. Obraje, Aguascalientes, Mexico

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Trials 2013, 14:77  doi:10.1186/1745-6215-14-77

Published: 19 March 2013

Abstract

Background

Spontaneous, nontraumatic intracerebral hemorrhage (ICH) is a subtype of stroke that causes a great amount of disability and 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 reduce the mortality and disability caused by ICH, with unsuccessful results. Recently, the use of fluoxetine in addition to physical rehabilitation has been proven useful to improve motor recovery following cerebral infarct. The purpose of this study is to test whether a 3-month treatment with fluoxetine enhances motor recovery in nondepressed patients with acute intracerebral hemorrhage.

Methods/design

Our study is a randomized, double-blind, placebo-controlled, multicenter clinical trial. We will recruit 86 patients with intracerebral hemorrhage of both sexes, aged >18 years, from four Mexican hospitals. The patients will receive either 20 mg of fluoxetine or a placebo once daily for 90 days. The primary outcome is the mean change in the Fugl-Meyer Motor Scale score between inclusion (day 0) and day 90. The secondary outcomes will be changes in the Barthel Index, the Modified Rankin scale and the National Institutes of Health stroke scale. The outcomes will be measured at day 42 ± 7days and at day 90, for a total of four visits with each subject (at screening and at 0, 42 and 90 days).

Discussion

Current guidelines recommend early supported hospital discharge and home-based rehabilitation programs as the only cost-effective intervention to aid the recovery of patients with intracerebral hemorrhage. Nevertheless, such interventions are dependent on available resources and funding, which make them very difficult to implement in developing countries. We believe that the identification of a helpful pharmacological intervention to aid the motor recovery of these patients will constitute a breakthrough that will have a major impact in reducing the burden of disease caused by this subtype of stroke worldwide, especially in the developing world.

Trial registration

Current Controlled Trials NCT01737541

Keywords:
Intracerebral hemorrhage; Stroke; Motor recovery; Fluoxetine; Randomized controlled trial