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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01043250
• Other study ID #: 2009-04-005
• Status: Completed
• Phase: N/A
• First received: January 4, 2010
• Last updated: July 22, 2011
• Start date: May 2009
• Est. completion date: December 2010

Study information

• Verified date: July 2011
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: December 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 59 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Samsung Medical Center	Korea Otsuka Pharmaceutical Co.,Ltd., Ministry of Health & Welfare, Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Body mass index (BMI)		between 2 and 24 months after starting medication	No