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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01043250
Recruitment Status : Completed
First Posted : January 6, 2010
Last Update Posted : July 25, 2011
Ministry of Health & Welfare, Korea
Korea Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Samsung Medical Center

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 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
U.S. FDA Resources

Receiving risperidone treatment
Receiving olanzapine treatment
Receiving aripiprazole

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

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 identifier (NCT number): NCT01043250

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.
Principal Investigator: Kyung Sue Hong, MD Samsung Medical Center

Responsible Party: Kyung Sue Hong, M.D., Professor, Samsung Medical Center 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:
atypical antipsychotics
eating behavior

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
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
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators