Orlistat therapy in clozapine- and olanzapine-treated patients who are overweight or obese
| ISRCTN | ISRCTN65731856 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65731856 |
| Protocol serial number | 02T-134 |
| Sponsor | The Stanley Medical Research Institute (SMRI) (USA) |
| Funder | The Stanley Medical Research Institute (SMRI) (USA) |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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). |
| Health condition(s) or problem(s) studied | Obesity |
| Intervention | Orlistat medication plus education about lifestyle habits |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Orlistat, clozapine, olanzapine |
| Primary outcome measure(s) |
Weight loss |
| Key secondary outcome measure(s) |
1. Number of responders (persons with weight loss of 5% or more) |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 80 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/01/2003 |
| Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- Finland
Study participating centre
Hospital of Kellokoski
Kellokoski
04500
Finland
04500
Finland
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 | 01/03/2011 | Yes | No |
