Acute effects of modafinil on cognitive function and activation of prefrontal cortex in people with schizophrenia

ISRCTN ISRCTN54567688
DOI https://doi.org/10.1186/ISRCTN54567688
Secondary identifying numbers N0078121977
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
16/12/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Sean Spence
Scientific

Academic Department of Psychiatry
University of Sheffield
The Longley Centre
Norwood Grange Drive
Sheffield
S5 7JT
United Kingdom

Phone +44 (0)114 2261513

Study information

Study designRandomised double-blind placebo-controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedMental and Behavioural Disorders: Schizophrenia
InterventionNot provided at time of registration
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)modafinil
Primary outcome measureStatistical analysis.
Secondary outcome measuresNot provided at time of registration
Overall study start date15/01/2003
Completion date30/04/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants30
Key inclusion criteria30 patients satisfying Diagnostic and Statistical Manual of Mental Disorders, Fourth edition (DSMIV) criteria for schizophrenia.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment15/01/2003
Date of final enrolment30/04/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Academic Department of Psychiatry
Sheffield
S5 7JT
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Doncaster and South Humber Healthcare NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2006 Yes No