NCT01737541

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

August 22, 2014

Status Verified

August 1, 2014

Enrollment Period

1.7 years

First QC Date

November 21, 2012

Last Update Submit

August 20, 2014

Conditions

Intracerebral HemorrhageMotor Impairment

Keywords

Cerebrovascular DisordersCardiovascular DiseasesIntracerebral HemorrhageSerotonin Uptake InhibitorsTherapeutic Uses

Outcome Measures

Primary Outcomes (1)

  • Fugl Meyer Motor Scale score

    Change from Baseline in Fugl Meyer Motor Scale score at 90 days

    Baseline and 90 days

Secondary Outcomes (3)

  • Barthel Index

    Baseline and 90 days

  • modified Rankin Scale

    Baseline and 90 days

  • NIH Stroke Scale

    Baseline and 90 days

Study Arms (2)

Fluoxetine

EXPERIMENTAL

fluoxetine per os 20 mg daily

Drug: Fluoxetine

Placebo

PLACEBO COMPARATOR

per os daily

Drug: Placebo

Interventions

FluoxetineDRUG
Also known as: Fluoxac
Fluoxetine
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Other major diseases with life expectancy less than 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital General de Zona #1

Aguascalientes, Aguascalientes, 202301, Mexico

Location

Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, 44280, Mexico

Location

Instituto Nacional de Neurología y Neurocirugía

Mexico City, Mexico City, 14269, Mexico

Location

Hospital Regional de Alta Especialidad Dr. Juan Graham Casasus

Villahermosa, Tabasco, 86126, Mexico

Location

Related Publications (2)

  • 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.

    PMID: 23510124BACKGROUND

  • 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.

    PMID: 31896491DERIVED

Related Links

MeSH Terms

Conditions

Cerebral HemorrhageCerebrovascular DisordersCardiovascular Diseases

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Juan M Marquez-Romero, MD

    Universidad Autónoma de Aguascalientes

    PRINCIPAL INVESTIGATOR

  • Angel A Arauz, PhD

    Instituto Nacional de Neurología y Neurocirugía

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Profesor Investigador

Study Record Dates

First Submitted

November 21, 2012

First Posted

November 29, 2012

Study Start

November 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

August 22, 2014

Record last verified: 2014-08

Locations

ME(4)