Intracerebral Hemorrhage, Motor Impairment
Conditions
Keywords
Cerebrovascular Disorders, Cardiovascular Diseases, Intracerebral Hemorrhage, Serotonin Uptake Inhibitors, Therapeutic Uses
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).
Interventions
DRUGFluoxetine
DRUGPlacebo
Sponsors
Universidad Autónoma de Aguascalientes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl Meyer Motor Scale score | Baseline and 90 days | Change from Baseline in Fugl Meyer Motor Scale score at 90 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Barthel Index | Baseline and 90 days | Change from Baseline in Barthel Index at 90 days |
| modified Rankin Scale | Baseline and 90 days | Change from Baseline in modified Rankin Scale at 90 days |
| NIH Stroke Scale | Baseline and 90 days | Change from Baseline in NIH Stroke Scale at 90 days |
Countries
Mexico
Outcome results
None listed