Fluoxetine or placebo for patients with a recent stroke

Phase 1

• Conditions: acute stroke; MedDRA version: 14.1 Level: PT Classification code 10061256 Term: Ischaemic stroke System Organ Class: 10029205 - Nervous system disorders; MedDRA version: 14.1 Level: PT Classification code 10019016 Term: Haemorrhagic stroke System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-005616-29-GB
• Lead Sponsor: niversity of Edinburgh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-06
• Study Completion: 2018-05-16
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 3127

Inclusion Criteria

1. New acute stroke 2. Brain imaging is compatible with intracerebral haemorrhage or ischaemic stroke 3. Randomisation can be performed between 2 and 15 days after stroke onset 4. Stroke deficits limiting function at the time of randomisation
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2000

Exclusion Criteria

• <18 years old • Subarachnoid haemorrhage, although where this is secondary to an intracerebral haemorrhage the patient will be eligible • Unlikely to be available for follow-up e.g. no fixed home address. Unable to speak English unless they have a close friend or relative who can act as a translator/interpretor • Patient has other life threatening illness (e.g. advanced cancer) likely to lead to death within a few months. • Depression requiring pharmacological treatment with a Selective Serotonin Reuptake Inhibitor (SSRI) Drug. (i.e. the same class of drug as Fluoxetine) • Pregnant or breast-feeding woman, women of child bearing age not taking contraception • History of epileptic seizures • Allergy to, or contraindications to fluoxetine including: o Hepatic failure o Renal failure (eGFR < 30ml/min) o Taken a monoamine oxidase inhibitor in last 5 weeks Co- administration of Fluoxetine and a Mono Amine Oxidase Inhibitors (MAOI) may result in life threatening interactions. Therefore, patients on MAOI inhibitors are ineligible for the FOCUS trial. Also, any patient needing treatment with a MAOI must stop their trial treatment for at least 5 weeks before commencing the MAOI). We will allow co-enrollment to another CTIMP, providing we can attribute adverse events to each specific IMP.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified