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

Sponsor

Samsung Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01043250

Collaborator

Ministry of Health & Welfare, Korea (Other), Korea Otsuka Pharmaceutical Co., Ltd. (Industry)

Enrollment

Location

Duration (Months)

4.3

Patients Per Site Per Month

Study Details

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	Intervention/Treatment	Phase
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 1, 2009

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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 [between 2 and 24months after starting medication]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 59 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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