Fluoxetine for Motor Recovery After Acute Intracerebral Hemorrhage (FMRICH)

Universidad Autónoma de Aguascalientes

Status and phase

Terminated

Phase 3

Conditions

Motor Impairment

Intracerebral Hemorrhage

Treatments

Drug: Fluoxetine

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01737541

83/11

Details and patient eligibility

About

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.

Full 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).

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.