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

July 22, 2011 updated by: Samsung Medical Center

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

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

81

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

outpatients clinic for schizophrenia

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
between 2 and 24months after starting medication

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

Korea Otsuka Pharmaceutical Co., Ltd.
Ministry of Health & Welfare, Korea

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

January 4, 2010

First Submitted That Met QC Criteria

January 5, 2010

First Posted (Estimate)

January 6, 2010

Study Record Updates

Last Update Posted (Estimate)

July 25, 2011

Last Update Submitted That Met QC Criteria

July 22, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-04-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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