|
Welcome
|
|
22 May 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| Orlistat therapy in clozapine- and olanzapine-treated patients who are overweight or obese |
| ISRCTN | ISRCTN65731856 |
| ClinicalTrials.gov identifier | |
| Public title | Orlistat therapy in clozapine- and olanzapine-treated patients who are overweight or obese |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | 02T-134 |
| Study hypothesis | Orlistat is better then placebo in olanzapine- or clozapine-treated psychiatric patients who are overweight or obese. |
| Lay summary | Not provided at time of registration |
| Ethics approval | Ethics approval received from the Ethics Committee for Pediatrics, Adolescent Medicine and Psychiatry, Hospital District of Helsinki and Uusimaa on the 16th June 2002 (ref: 314/E7/02). |
| Study design | Randomised controlled trial |
| Countries of recruitment | Finland |
| Disease/condition/study domain | Obesity |
| Participants - inclusion criteria |
Male or female in- or out-patients will be recruited if they:
1. Are aged 18 - 65 years 2. Have had a psychotic disorder which is currently under a reasonably good (according to the investigator’s judgement) control with on-going clozapine or olanzapine therapy i.e. a shift to another antipsychotic or augmentation with another psychotropic drug is not expected during at least the next several months 3. Have had an underlying psychotic disorder, the nature of which, requires prolonged antipsychotic medication i.e. discontinuation of antipsychotic medication is not expected during at least the next several months 4. Have a body mass index (BMI) of 28 - 43 kg/m^2 5. The patient has a level of understanding enabling reasonable cooperation with the investigator and likely able to comply with the study protocol, including dietary restrictions 6. Have given written informed consent |
| Participants - exclusion criteria |
At screening:
1. Previous exposure to orlistat 2. General contraindications to orlistat therapy e.g. chronic malabsorption syndrome or cholestasis 3. Current treatment with weight loss medications 4. Other than clozapine or olanzapine psychotropic or somatic medication known to either significantly increase or decrease body weight (e.g. some antipsychotics, antidepressants, mood stabilizers etc.) is not allowed. However, if necessary, such a medication can be continued, provided that both the medication and weight have remained stable during four weeks prior to enrolment. 5. Serious physical illness 6. Diabetes mellitus (DM), type I (patients with DM type II are not excluded) 7. History of substance addiction or abuse within less than or equal to 3 months prior to enrolment 8. Expected poor compliance with the study protocol and/or poor control of fat intake 9. For females of child-bearing potential: pregnancy, lactation, or inability or unwillingness to use medically acceptable contraception means during the study 10. Significant (greater than or equal to 1 kg) weight change within less than or equal to 4 weeks prior to enrolment 11. Polydipsia, bulimia, binge-eating, or other condition with rapid unexpected weight changes At baseline (in addition to those at screening): 1. Clinically relevant abnormalities in the laboratory tests 2. Poor compliance at screening e.g. inaccurate intake of study drug (investigator’s decision) |
| Anticipated start date | 01/01/2003 |
| Anticipated end date | 31/12/2004 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 80 |
| Interventions | Orlistat medication plus education about lifestyle habits |
| Primary outcome measure(s) | Weight loss |
| Secondary outcome measure(s) |
1. Number of responders (persons with weight loss of 5% or more)
2. BMI 3. Waist measurement 4. Lipids |
| Sources of funding | The Stanley Medical Research Institute (SMRI) (USA) |
| Trial website | |
| Publications | 1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20816037 |
| Contact name | Dr Grigori Joffe |
| Address | Hospital of Kellokoski |
| City/town | Kellokoski |
| Zip/Postcode | 04500 |
| Country | Finland |
| Tel | +358 (0)405 136500 |
| Fax | +358 (0)927 163461 |
| grigori.joffe@hus.fi | |
| Sponsor | The Stanley Medical Research Institute (SMRI) (USA) |
| Address |
5430 Grosvenor Lane
Suite 200 |
| City/town | Bethesda |
| Zip/Postcode | MD 20814-2142 |
| Country | United States of America |
| Tel | +1 301 571 0760 ext. 119 |
| Fax | +1 301 571 0769 |
| Herrerax@stanleyresearch.org | |
| Sponsor website: | http://www.stanleyresearch.org |
| Date applied | 19/09/2005 |
| Last edited | 04/07/2011 |
| Date ISRCTN assigned | 25/05/2006 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|