Clinical trial NCT01737541: Fluoxetine for Motor Recovery After Acute Intracerebral Hemorrhage
Official title: Fluoxetine for Motor Recovery After Acute Intracerebral Hemorrhage (FMRICH): a Randomised Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Intracerebral Hemorrhage
Motor Impairment
Keywords: Cerebrovascular Disorders
Cardiovascular Diseases
Intracerebral Hemorrhage
Serotonin Uptake Inhibitors
Therapeutic Uses
Lead sponsor: Universidad Autónoma de Aguascalientes
Sponsor class: OTHER
First posted: 2012-11-29
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Fugl Meyer Motor Scale score
timeFrame: Baseline and 90 days
Secondary outcomes:
measure: Barthel Index
timeFrame: Baseline and 90 days
measure: modified Rankin Scale
timeFrame: Baseline and 90 days
measure: NIH Stroke Scale
timeFrame: Baseline and 90 days
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
state: Jalisco
city: Villahermosa
country: Mexico
facility: Hospital Regional de Alta Especialidad Dr. Juan Graham Casasus
state: Tabasco
city: Aguascalientes
country: Mexico
facility: Hospital General de Zona #1
city: Mexico City
country: Mexico
facility: Instituto Nacional de Neurología y Neurocirugía
Study officials:
affiliation: Universidad Autónoma de Aguascalientes
name: Juan M Marquez-Romero, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional de Neurología y Neurocirugía
name: Angel A Arauz, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Marquez-Romero JM, Reyes-Martinez M, Huerta-Franco MR, Ruiz-Franco A, Silos H, Arauz A. Fluoxetine for motor recovery after acute intracerebral hemorrhage, the FMRICH trial. Clin Neurol Neurosurg. 2020 Mar;190:105656. doi: 10.1016/j.clineuro.2019.105656. Epub 2019 Dec 28.