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

NCT01043250 | Completed DMC

• 1 other identifier: 2009-04-005
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

schizophrenia; atypical antipsychotics; appetite; eating behavior

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Body mass index (BMI)

  between 2 and 24 months after starting medication

Study Arms (3)

Risperidone

Receiving risperidone treatment

Olanzapine

Receiving olanzapine treatment

Aripiprazole

Receiving aripiprazole

Eligibility Criteria

• Age: 19 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

outpatients clinic for schizophrenia

You may qualify if:

• Patients meeting the DSM-IV criteria of schizophrenia, schizophreniform disorder, or schizoaffective disorder
• Male and female patients aged 19\~59
• Patients receiving monotherapy with one of the three AAPs, i.e., olanzapine, risperidone, and aripiprazole for more than two and less than 24 months
• Patients who had at least one-week antipsychotics-free periods before starting the above antipsychotics
• Clinically stable and able to complete the questionnaires
• Patients who sufficiently understand the objective of the study and sign informed consent form

You may not qualify if:

• Patients having any medical illness or taking any medicine affecting appetite and body weight
• Patients with severe and unstable medical, neurological or systemic illnesses
• Patients having any comorbid psychiatric disorders including substance use disorders and eating disorders.
• Pregnant or breast-feeding women

Sponsors & Collaborators

• Samsung Medical Center: lead
• Ministry of Health & Welfare, Korea: collaborator
• Korea Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related 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. doi: 10.4088/jcp.v62n0404.

  PMID: 11379836 BACKGROUND

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Feeding Behavior

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavior, Animal; Behavior

Study Officials

• Kyung Sue Hong, MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 4, 2010
• First Posted: January 6, 2010
• Study Start: May 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 25, 2011

Record last verified: 2011-07

Locations

KR (1)