SchizophreniaNCT01043250
Effects of Atypical Antipsychotics on Appetite and Eating Behavior of Schizophrenia Patients
An observational study of Schizophrenia and Schizoaffective Disorder, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 59 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- How many people
- 81 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2009to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 59 years
- All sexes
- No healthy volunteers
- Adult
Study population: outpatients clinic for schizophrenia
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- schizophrenia, atypical antipsychotics, appetite, eating behavior
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Risperidone | Receiving risperidone treatment | |
| Olanzapine | Receiving olanzapine treatment | |
| Aripiprazole | Receiving aripiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in appetite and eating behavior Rating Scales: Drug-related eating behavior questionnaire & Korean version of General Food Craving Questionnaire
Measured: between 2 and 24months after starting medication
Secondary outcomes (1)
Body mass index (BMI)
Measured: between 2 and 24 months after starting medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2010 (estimated)
- Study startMay 2009
- Primary completionApr 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea, Korea Otsuka Pharmaceutical Co., Ltd.
- Investigators
- Kyung Sue Hong, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043250
- Sponsor's protocol ID
- 2009-04-005
- Status last verified
- Jul 2011
- First submitted
- 4 Jan 2010
- Last updated
- 25 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.4088/jcp.v62n0404.
PubMed 11379836
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01043250
- Acronym / sponsor ID
- 2009-04-005
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- schizophrenia, atypical antipsychotics, appetite, eating behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea, Korea Otsuka Pharmaceutical Co., Ltd.
- Study start
- May 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 6 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Risperidone | – | –Receiving risperidone treatment |
| Olanzapine | – | –Receiving olanzapine treatment |
| Aripiprazole | – | –Receiving aripiprazole |
Who may qualify
- Ages
- 19 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- outpatients clinic for schizophrenia
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Body mass index (BMI)
Time frame: between 2 and 24 months after starting medication
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2011.
- Background: PubMed 11379836Basson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyung Sue Hong, MD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Schizoaffective Disorder, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01043250, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2011.