Clinical trial NCT01043250: Effects of Atypical Antipsychotics on Appetite and Eating Behavior of Schizophrenia Patients
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: schizophrenia
atypical antipsychotics
appetite
eating behavior
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Ministry of Health & Welfare, Korea
name: Korea Otsuka Pharmaceutical Co., Ltd.
First posted: 2010-01-06
Enrollment: 81
Sex: ALL
Minimum age (years): 19
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: outpatients clinic for schizophrenia

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.

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.

Eligibility 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

Primary outcomes:
measure: Changes in appetite and eating behavior Rating Scales: Drug-related eating behavior questionnaire & Korean version of General Food Craving Questionnaire
timeFrame: between 2 and 24months after starting medication
Secondary outcomes:
measure: Body mass index (BMI)
timeFrame: between 2 and 24 months after starting medication
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Kyung Sue Hong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.4088/jcp.v62n0404.