Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/09/2005
Date assigned
25/05/2006
Last edited
04/07/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 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

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 (investigator’s 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

http://www.stanleyresearch.org

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

  1. 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.

Additional files

Editorial Notes