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 |
| Protocol serial number | N0078121977 |
| Sponsor | Department of Health (UK) |
| Funder | Doncaster and South Humber Healthcare NHS Trust (UK) |
- 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
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind placebo-controlled study |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Mental and Behavioural Disorders: Schizophrenia |
| Intervention | Not provided at time of registration |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | modafinil |
| Primary outcome measure(s) |
Statistical analysis. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/04/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 30 |
| Key inclusion criteria | 30 patients satisfying Diagnostic and Statistical Manual of Mental Disorders, Fourth edition (DSMIV) criteria for schizophrenia. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 15/01/2003 |
| Date of final enrolment | 30/04/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Academic Department of Psychiatry
Sheffield
S5 7JT
United Kingdom
S5 7JT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
