Fluoxetine for Motor Recovery After Acute Intracerebral Hemorrhage

Intracerebral Hemorrhage Clinical Trial

— FMRICH  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01737541
• Other study ID #: 83/11
• Status: Terminated
• Phase: Phase 3
• First received: November 21, 2012
• Last updated: August 20, 2014
• Start date: November 2012
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• Source: Universidad Autónoma de Aguascalientes
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage
• Motor Impairment

Intervention

Drug:
• Fluoxetine

• Placebo

Locations

Country	Name	City	State
Mexico	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

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autónoma de Aguascalientes

Country where clinical trial is conducted

Mexico, 

References & Publications (1)

Marquez-Romero JM, Arauz A, Ruiz-Sandoval JL, Cruz-Estrada Ede L, Huerta-Franco MR, Aguayo-Leytte G, Ruiz-Franco A, Silos H. Fluoxetine for motor recovery after acute intracerebral hemorrhage (FMRICH): study protocol for a randomized, double-blind, placebo-controlled, multicenter trial. Trials. 2013 Mar 19;14:77. doi: 10.1186/1745-6215-14-77. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl Meyer Motor Scale score	Change from Baseline in Fugl Meyer Motor Scale score at 90 days	Baseline and 90 days	No
Secondary	Barthel Index	Change from Baseline in Barthel Index at 90 days	Baseline and 90 days	No
Secondary	modified Rankin Scale	Change from Baseline in modified Rankin Scale at 90 days	Baseline and 90 days	No
Secondary	NIH Stroke Scale	Change from Baseline in NIH Stroke Scale at 90 days	Baseline and 90 days	No

External Links

•   Full text protocol