Effects of Atypical Antipsychotics on Appetite and Eating Behavior of Schizophrenia Patients

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ClinicalTrials.gov Identifier: NCT01043250

Recruitment Status : Completed

First Posted : January 6, 2010

Last Update Posted : July 25, 2011

Sponsor:

Collaborators:

Ministry of Health & Welfare, Korea

Korea Otsuka Pharmaceutical Co., Ltd.

Information provided by:

Samsung Medical Center

Study Description

Brief Summary:

In this study, we are going to investigate quantitative and qualitative natures of appetite and eating-behavior changes induced by atypical antipsychotics, i.e., risperidone, olanzapine and aripiprazole, in schizophrenia patients.

Condition or disease
Schizophrenia Schizoaffective Disorder

Detailed Description:

This is an observational study. 2 Self-report questionnaires assessing changes of appetite and eating behaviors after medication are applied to patients who have been receiving one of the three atypical antipsychotics. We are going to compare changes of appetite and eating behaviors after medication between three atypical antipsychotics and investigate the association between changes of appetite and eating behaviors and changes of weight after medication.

Study Design


Study Type :	Observational
Actual Enrollment :	81 participants
Observational Model:	Case-Only
Time Perspective:	Retrospective
Official Title:	Effects of Atypical Antipsychotics on Appetite and Eating Behavior of Schizophrenia Patients: Analysis for Three Drugs, Olanzapine, Risperidone, and Aripiprazole, Known to Induce Different Degrees of Weight Gain
Study Start Date :	May 2009
Actual Primary Completion Date :	April 2010
Actual Study Completion Date :	December 2010

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Schizoaffective disorder Schizophrenia

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Risperidone Receiving risperidone treatment
Olanzapine Receiving olanzapine treatment
Aripiprazole Receiving aripiprazole

Outcome Measures

Primary Outcome Measures :

Changes in appetite and eating behavior Rating Scales: Drug-related eating behavior questionnaire & Korean version of General Food Craving Questionnaire [ Time Frame: between 2 and 24months after starting medication ]

Secondary Outcome Measures :

Body mass index (BMI) [ Time Frame: between 2 and 24 months after starting medication ]

Eligibility Criteria

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Ages Eligible for Study:	19 Years to 59 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

outpatients clinic for schizophrenia

Criteria

Inclusion Criteria:

Patients meeting the DSM-IV criteria of schizophrenia, schizophreniform disorder, or schizoaffective disorder
Male and female patients aged 19~59
Patients receiving monotherapy with one of the three AAPs, i.e., olanzapine, risperidone, and aripiprazole for more than two and less than 24 months
Patients who had at least one-week antipsychotics-free periods before starting the above antipsychotics
Clinically stable and able to complete the questionnaires
Patients who sufficiently understand the objective of the study and sign informed consent form

Exclusion Criteria:

Patients having any medical illness or taking any medicine affecting appetite and body weight
Patients with severe and unstable medical, neurological or systemic illnesses
Patients having any comorbid psychiatric disorders including substance use disorders and eating disorders.
Pregnant or breast-feeding women

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01043250

Locations


Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710

Sponsors and Collaborators

Samsung Medical Center

Ministry of Health & Welfare, Korea

Korea Otsuka Pharmaceutical Co., Ltd.

Investigators


Principal Investigator:	Kyung Sue Hong, MD	Samsung Medical Center

More Information

Publications:

Basson BR, Kinon BJ, Taylor CC, Szymanski KA, Gilmore JA, Tollefson GD. Factors influencing acute weight change in patients with schizophrenia treated with olanzapine, haloperidol, or risperidone. J Clin Psychiatry. 2001 Apr;62(4):231-8.


Responsible Party:	Kyung Sue Hong, M.D., Professor, Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT01043250 History of Changes
Other Study ID Numbers:	2009-04-005
First Posted:	January 6, 2010 Key Record Dates
Last Update Posted:	July 25, 2011
Last Verified:	July 2011

Keywords provided by Samsung Medical Center:


schizophrenia atypical antipsychotics appetite eating behavior

Additional relevant MeSH terms:


Schizophrenia Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Risperidone Antipsychotic Agents Aripiprazole Olanzapine Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs	Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Dopamine Antagonists Dopamine Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators

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