Contact information
Type
Scientific
Primary contact
Dr Grigori Joffe
ORCID ID
Contact details
Hospital of Kellokoski
Kellokoski
04500
Finland
+358 (0)405 136500
grigori.joffe@hus.fi
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
02T-134
Study information
Scientific title
Acronym
Study hypothesis
Orlistat is better then placebo in olanzapine- or clozapine-treated psychiatric patients who are overweight or obese.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Obesity
Intervention
Orlistat medication plus education about lifestyle habits
Intervention type
Drug
Phase
Not Specified
Drug names
Orlistat, clozapine, olanzapine
Primary outcome measures
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 trial start date
01/01/2003
Overall trial end date
31/12/2004
Reason abandoned
Eligibility
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 type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
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
Trial participating centre
Hospital of Kellokoski
Kellokoski
04500
Finland
Sponsor information
Organisation
The Stanley Medical Research Institute (SMRI) (USA)
Sponsor details
5430 Grosvenor Lane
Suite 200
Bethesda
MD 20814-2142
United States of America
+1 301 571 0760 ext. 119
Herrerax@stanleyresearch.org
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
The Stanley Medical Research Institute (SMRI) (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20816037
Publication citations
-
Results
Tchoukhine E, Takala P, Hakko H, Raidma M, Putkonen H, Räsänen P, Terevnikov V, Stenberg JH, Eronen M, Joffe G, Orlistat in clozapine- or olanzapine-treated patients with overweight or obesity: a 16-week open-label extension phase and both phases of a randomized controlled trial., J Clin Psychiatry, 2011, 72, 3, 326-330, doi: 10.4088/JCP.09m05283yel.