| Source of record | UK Trials |
| ISRCTN | ISRCTN87255415 |
| Date ISRCTN assigned | 12/09/2003 |
| Local reference number(s) | N0530115316 |
| Public title | The efficacy of pindolol in reducing weight gain associated with the use of Olanzapine |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Nutritional, Metabolic, Endocrine: Obesity |
| Study hypothesis | 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 36 Participants, who will be recruited through the clinicians working with Camden and Islington Mental Health and Social Care Trust. |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/08/2002 |
| Anticipated end date | 01/09/2003 |
| Status of trial | Completed |
| Target number of participants | 36 |
| Interventions | Randomised controlled trial:
A. Olanzapine treatment in combination with pinadolol
B. Olazapine treatment alone |
| Primary outcome measure(s) | 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 measure(s) | Not provided at time of registration |
| Sources of funding | North Central London Community Research Consortium |
| Sponsor name | Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK) |
| Sponsor details | The Department of Health
Richmond House
79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 (0)20 7307 2623 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.doh.gov.uk |
| Contact name | Dr Craig Ritchie |
| Contact details | Metabolic and Clinical Trials Unit
Royal Free and University College Medical School
Royal Free Campus
Rowland Hill Street
London
United Kingdom
NW3 2PF |
| Contact telephone | +44 020 7794 0500 x3951 |
| Contact fax | +44 020 7830 2808 |
| Contact email | c.richie@medsch.ucl.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN87255415 |
| Date last extracted from ISRCTN register | 17/04/2008 |
