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

• ClinicalTrials.gov Identifier: NCT01043250
• Recruitment Status: Completed
• First Posted: January 6, 2010
• Last Update Posted: July 25, 2011
• Sponsor: Samsung Medical Center
• Collaborators: Ministry of Health & Welfare, Korea; Korea Otsuka Pharmaceutical Co., Ltd.
• Information provided by: Samsung Medical Center

Tracking Information

• First Submitted Date: January 4, 2010
• First Posted Date: January 6, 2010
• Last Update Posted Date: July 25, 2011
• Study Start Date: May 2009
• Actual Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 5, 2010): 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 ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: January 5, 2010): Body mass index (BMI) [ Time Frame: between 2 and 24 months after starting medication ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: outpatients clinic for schizophrenia

Condition

• Schizophrenia
• Schizoaffective Disorder

• Intervention: Not Provided

Study Groups/Cohorts

• Risperidone
  Receiving risperidone treatment
• Olanzapine
  Receiving olanzapine treatment
• Aripiprazole
  Receiving aripiprazole

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 22, 2011): 81
• Original Estimated Enrollment (submitted: January 5, 2010): 90
• Actual Study Completion Date: December 2010
• Actual Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years to 59 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT01043250
• Other Study ID Numbers: 2009-04-005
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Kyung Sue Hong, M.D., Professor, Samsung Medical Center
• Study Sponsor: Samsung Medical Center

Collaborators

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

Investigators

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

• PRS Account: Samsung Medical Center
• Verification Date: July 2011