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Efficacy of Fluoxetine - a Trial in Stroke

NCT02683213 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2020-09-02

No results posted yet for this study

Summary

The purpose of this study is to investigate whether routine administration of fluoxetine 20mg once daily in the 6 months initiated during the acute stroke improves the patient's functional outcome.

EFFECTS is an investigator lead Sweden-based, multicenter, parallel group, double blind placebo controlled trial with broad entry criteria and follow up at 6 and 12 months.

EFFECTS managed to recruit its anticipated numbers of 1,500 participants between 20th October 2014 and 28th June 2019. Data will be unblinded when the 6-months follow-up is completed, and the primary outcome is due to report on May 2020.

Conditions

Interventions

DRUG

Fluoxetine

Fluoxetine 20mg once daily for 6 months.

DRUG

Placebo

Matching placebo.

Sponsors & Collaborators

  • The Swedish Research Council

    collaborator OTHER_GOV

  • Swedish Heart Lung Foundation

    collaborator OTHER

  • Stroke-Riksförbundet

    collaborator UNKNOWN

  • Konung Gustaf V:s och Drottning Victorias Frimurarestiftelse

    collaborator UNKNOWN

  • Hjärnfonden (The Swedish Brain foundation)

    collaborator UNKNOWN

  • The Swedish Medical Association

    collaborator OTHER

  • Karolinska Institutet

    lead OTHER

Principal Investigators

  • Erik Lundström, MD, PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-20
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02683213 on ClinicalTrials.gov