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

This study has been completed.
Sponsor:
Collaborators:
Ministry of Health & Welfare, Korea
Korea Otsuka Pharmaceutical Co.,Ltd.
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01043250
First received: January 4, 2010
Last updated: July 22, 2011
Last verified: July 2011
  Purpose

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
Schizophrenia
Schizoaffective Disorder

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body mass index (BMI) [ Time Frame: between 2 and 24 months after starting medication ] [ Designated as safety issue: No ]

Enrollment: 81
Study Start Date: May 2009
Study Completion Date: December 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Risperidone
Receiving risperidone treatment
Olanzapine
Receiving olanzapine treatment
Aripiprazole
Receiving aripiprazole

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

Ages Eligible for Study:   19 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

outpatients clinic for schizophrenia

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01043250

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Ministry of Health & Welfare, Korea
Korea Otsuka Pharmaceutical Co.,Ltd.
Investigators
Principal Investigator: Kyung Sue Hong, MD Samsung Medical Center
  More Information

Publications:
Responsible Party: Kyung Sue Hong, M.D., Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01043250     History of Changes
Other Study ID Numbers: 2009-04-005
Study First Received: January 4, 2010
Last Updated: July 22, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
schizophrenia
atypical antipsychotics
appetite
eating behavior

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Aripiprazole
Antipsychotic Agents
Olanzapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014