An international study of improving treatment for the most severely ill with schizophrenia
| ISRCTN | ISRCTN41543404 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41543404 |
| ClinicalTrials.gov (NCT) | NCT00272584 |
| Protocol serial number | N0544099315 |
| Sponsor | Department of Health (UK) |
| Funder | Cambridge Consortium - Addenbrookes (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 17/11/2009
- 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 Peter J McKenna
Scientific
Scientific
Box No 316
The Yews
Fulbourn Hospital
Cambridge
CB1 5EY
United Kingdom
| Phone | +44 (0)1223 218814 |
|---|---|
| peter.mckenna@virgin.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Background: Clozapine represents a significant advance in the treatment of the most severely ill patients with schizophrenia. However, a subgroup continues to be psychotic and disabled even with adequate clozapine treatment. A trial of risperidone augmentation of clozapine is proposed. This strategy is based on the rationale that risperidone has some documented efficacy as monotherapy in severely ill patients, and may have a somewhat different profile of effects on cognition compared to clozapine. Hypothesis: Risperidone augmentation will reduce symptoms and improve working memory compared to placebo augmentation. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Schizophrenia |
| Intervention | A double-blind, randomised controlled trial of risperidone compared to placebo augmentation will be carried out with 100 subjects. All subjects will continue on clozapine therapy. Symptomatic, functional, side effects and neurocognitive assessments will be carried out at 4, 8 and 26 weeks. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | clozapine, risperidone |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 20/03/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | 100 Subjects (PROJ 16/10/2000) |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 20/03/2001 |
| Date of final enrolment | 20/03/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Box No 316
Cambridge
CB1 5EY
United Kingdom
CB1 5EY
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 | 02/02/2006 | Yes | No |
