Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01043250
Recruitment Status : Completed
First Posted : January 6, 2010
Last Update Posted : July 25, 2011
Sponsor:
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
Change History
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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