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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
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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
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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

MedlinePlus related topics: Schizophrenia

Groups and Cohorts
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Group/Cohort
Risperidone
Receiving risperidone treatment
Olanzapine
Receiving olanzapine treatment
Aripiprazole
Receiving aripiprazole


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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:

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

Exclusion Criteria:

  1. Patients having any medical illness or taking any medicine affecting appetite and body weight
  2. Patients with severe and unstable medical, neurological or systemic illnesses
  3. Patients having any comorbid psychiatric disorders including substance use disorders and eating disorders.
  4. Pregnant or breast-feeding women
Contacts and Locations
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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
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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
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Principal Investigator: Kyung Sue Hong, MD Samsung Medical Center
More Information
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Publications:

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Responsible Party: Kyung Sue Hong, M.D., Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01043250    
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:
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Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders