Orlistat therapy in clozapine- and olanzapine-treated patients who are overweight or obese

Completed

• Conditions: Obesity; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN65731856
• Lead Sponsor: The Stanley Medical Research Institute (SMRI) (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-25
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight loss

Secondary Outcome Measures

Name	Time	Method
1. Number of responders (persons with weight loss of 5% or more)<br>2. BMI<br>3. Waist measurement<br>4. Lipids