Condition category
Circulatory System
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
16/02/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr H I van Genderen

ORCID ID

Contact details

Rehabilitation Centre 'The Roessingh' Enschede
P.O. Box 310
Enschede
7500 AH
Netherlands
+31 (0)53 487 5765
h.vangenderen@rrd.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Acronym

flu2006

Study hypothesis

1. Long term use of fluoxetine causes the excitability of the primary motor area of the brain to change
2. Long term administration of fluoxetine causes the muscle activation patterns to change

Ethics approval

Approval received from the Medical Ethics committee of Medisch Spectrum Twente (Enschede, The Netherlands) on the 7th February 2007 (ref: P06-53).

Study design

Randomised, placebo controlled, parallel group, double blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Stroke

Intervention

20 mg of fluoxetine during 12 weeks versus placebo.

Intervention type

Drug

Phase

Not Specified

Drug names

Fluoxetine

Primary outcome measures

1. Excitability of the primary motor area, measured by motor threshold and stimulus response curve
2. Muscle activation, measured by calculating Root Mean Square (RMS) during isometric and dynamic movements

Secondary outcome measures

1. Brain activation patterns
2. Phase synchronisation of the brain
3. Motor function

Overall trial start date

01/01/2007

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Chronic ischaemic stroke patients (more than six months after stroke)
2. Aged over 18

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

28

Participant exclusion criteria

1. Patients suffering from another neurological disease
2. Uncompensated hemineglect or cognitive disabilities
3. Epilepsy, or first epileptic insult post stroke
4. Patients with first grade relatives suffering from epilepsy
5. Pregnancy
6. Pacemaker
7. Pathological heart rhythms disorders
8. Use of anti-depressants

Recruitment start date

01/01/2007

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Rehabilitation Centre 'The Roessingh' Enschede
Enschede
7500 AH
Netherlands

Sponsor information

Organisation

Rehabilitation Centre 'The Roessingh' Enschede (The Netherlands)

Sponsor details

P.O. Box 310
Enschede
7500 AH
Netherlands
m.j.ijzerman@utwente.nl

Sponsor type

Research organisation

Website

http://www.rrd.nl/www/indexa.html

Funders

Funder type

Research organisation

Funder name

St. Jorisstichting (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ridderlijke Duitsche Order (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes