Fluoxetine for Motor Recovery After Acute Intracerebral Hemorrhage (FMRICH)

This study has been terminated.
(Study recruitment was suspended due to lack of funding)
Sponsor:
Information provided by (Responsible Party):
Juan Manuel Marquez-Romero, Universidad Autónoma de Aguascalientes
ClinicalTrials.gov Identifier:
NCT01737541
First received: November 21, 2012
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Intracerebral Hemorrhage
Motor Impairment
Drug: Fluoxetine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Fluoxetine for Motor Recovery After Acute Intracerebral Hemorrhage (FMRICH): a Randomised Placebo-controlled Trial

Resource links provided by NLM:


Further study details as provided by Universidad Autónoma de Aguascalientes:

Primary Outcome Measures:
  • Fugl Meyer Motor Scale score [ Time Frame: Baseline and 90 days ] [ Designated as safety issue: No ]
    Change from Baseline in Fugl Meyer Motor Scale score at 90 days


Secondary Outcome Measures:
  • Barthel Index [ Time Frame: Baseline and 90 days ] [ Designated as safety issue: No ]
    Change from Baseline in Barthel Index at 90 days

  • modified Rankin Scale [ Time Frame: Baseline and 90 days ] [ Designated as safety issue: No ]
    Change from Baseline in modified Rankin Scale at 90 days

  • NIH Stroke Scale [ Time Frame: Baseline and 90 days ] [ Designated as safety issue: No ]
    Change from Baseline in NIH Stroke Scale at 90 days


Enrollment: 32
Study Start Date: November 2012
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluoxetine
fluoxetine per os 20 mg daily
Drug: Fluoxetine
Other Name: Fluoxac
Placebo Comparator: Placebo
per os daily
Drug: Placebo

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01737541

Locations
Mexico
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico, 44280
Hospital Regional de Alta Especialidad Dr. Juan Graham Casasus
Villahermosa, Tabasco, Mexico, 86126
Hospital General de Zona #1
Aguascalientes, Mexico, 202301
Instituto Nacional de Neurología y Neurocirugía
Mexico City, Mexico, 14269
Sponsors and Collaborators
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 Neurología y Neurocirugía
  More Information

Additional Information:
Publications:
Responsible Party: Juan Manuel Marquez-Romero, Profesor Investigador, Universidad Autónoma de Aguascalientes
ClinicalTrials.gov Identifier: NCT01737541     History of Changes
Other Study ID Numbers: 83/11
Study First Received: November 21, 2012
Last Updated: August 20, 2014
Health Authority: Mexico: Ethics Committee

Keywords provided by Universidad Autónoma de Aguascalientes:
Cerebrovascular Disorders
Cardiovascular Diseases
Intracerebral Hemorrhage
Serotonin Uptake Inhibitors
Therapeutic Uses

Additional relevant MeSH terms:
Hemorrhage
Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014