The efficacy of pindolol in reducing weight gain associated with the use of Olanzapine
| ISRCTN | ISRCTN87255415 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87255415 |
| Secondary identifying numbers | N0530115316 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 06/12/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Craig Ritchie
Scientific
Scientific
Metabolic and Clinical Trials Unit
Royal Free and University College Medical School
Royal Free Campus
Rowland Hill Street
London
NW3 2PF
United Kingdom
| Phone | +44 020 7794 0500 x3951 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | The aim of the study is to determine the effect that the addition of pindolol has on weight gain associated with Olanzapine. We hypothesise that due to its central effects on serotonergic pathways, pindolol will increase feelings of satiety and consequently reduce weight gain commonly observed in the treatment of psychosis with Olanzapine. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Obesity |
| Intervention | Randomised controlled trial: A. Olanzapine treatment in combination with pinadolol B. Olazapine treatment alone |
| Intervention type | Other |
| Primary outcome measure | Olanzapine is commonly used in the treatment of schizophrenia. Whilst generally well tolerated, weight gain is known to effect compliance and acceptability to many patients. In patients who continue to take Olanzapine despite gaining weight there are general health and psychological ramifications. If weight gain could be minimised then this burden may be reduced, leading to a lessening of pressure upon NHS resources. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/08/2002 |
| Completion date | 01/09/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 36 |
| Key inclusion criteria | 36 Participants, who will be recruited through the clinicians working with Camden and Islington Mental Health and Social Care Trust. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/08/2002 |
| Date of final enrolment | 01/09/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Metabolic and Clinical Trials Unit
London
NW3 2PF
United Kingdom
NW3 2PF
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
North Central London Community Research Consortium
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
