Intracerebral Hemorrhage | Fluoxetine for Motor Recovery After Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Fluoxetinefluoxetine per os 20 mg daily
Placeboper os daily
Start Date: November 2012
Completed Date: August 2014
Phase: Phase 3
Primary Outcome: Fugl Meyer Motor Scale score
Secondary Outcome: Barthel Index
Study sponsors, principal investigator, and references
Principal Investigator: Juan M Marquez-Romero, MD
Lead Sponsor: Universidad Autónoma de Aguascalientes
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.