Orlistat therapy in clozapine- and olanzapine-treated patients who are overweight or obese
| ISRCTN | ISRCTN65731856 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65731856 |
| Secondary identifying numbers | 02T-134 |
- Submission date
- 19/09/2005
- Registration date
- 25/05/2006
- Last edited
- 04/07/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Grigori Joffe
Scientific
Scientific
Hospital of Kellokoski
Kellokoski
04500
Finland
| Phone | +358 (0)405 136500 |
|---|---|
| grigori.joffe@hus.fi |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study hypothesis | Orlistat is better then placebo in olanzapine- or clozapine-treated psychiatric patients who are overweight or obese. |
| Ethics approval(s) | 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). |
| Condition | Obesity |
| Intervention | Orlistat medication plus education about lifestyle habits |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Orlistat, clozapine, olanzapine |
| Primary outcome measure | Weight loss |
| Secondary outcome measures | 1. Number of responders (persons with weight loss of 5% or more) 2. BMI 3. Waist measurement 4. Lipids |
| Overall study start date | 01/01/2003 |
| Overall study end date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 |
| Participant 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 investigators 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 |
| Participant 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 (investigators decision) |
| Recruitment start date | 01/01/2003 |
| Recruitment end date | 31/12/2004 |
Locations
Countries of recruitment
- Finland
Study participating centre
Hospital of Kellokoski
Kellokoski
04500
Finland
04500
Finland
Sponsor information
The Stanley Medical Research Institute (SMRI) (USA)
Research organisation
Research organisation
5430 Grosvenor Lane
Suite 200
Bethesda
MD 20814-2142
United States of America
| Phone | +1 301 571 0760 ext. 119 |
|---|---|
| Herrerax@stanleyresearch.org | |
| Website | http://www.stanleyresearch.org |
"ROR" |
https://ror.org/01pj5nn22 |
Funders
Funder type
Research organisation
The Stanley Medical Research Institute (SMRI) (USA)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2011 | Yes | No |
