SchizophreniaMESSAGENCT00448630
An Observational Study On Metabolic Syndrome Parameters In Schizophrenia Patients Treated With Atypical Antipsychotics
An observational study of Schizophrenia and Metabolic Syndrome X, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 47 sites in Turkey (Türkiye).
Trial summary
The purpose of the study is to find and follow-up the metabolic syndrome parameters on patients administering atypical antipsychotics. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia, Metabolic Syndrome X
- How many people
- 328 participants
- Where
- 47 sitesTurkey (Türkiye)
- Study dates
- 23 Oct 2007to 30 Jul 2008
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: * Female and male patients diagnosed as schizophrenia by DSM-IV criteria; Age between 18-45 years * Patients who started atypical antipsychotic drug treatment or patients who switched from the previous conventional or atypical antipsychotic treatment to another atypical antipsychotic drug treatment by the decision of their physicians in psychiatry clinics in state and university hospitals.
Who may be able to join
- Female and male patients diagnosed as schizophrenia by the Diagnostic and Statistical Manual of Mental Disorders.
- Age between 18-45 years
- Patients who started atypical antipsychotic drug treatment or patients who switched from the previous conventional or atypical antipsychotic treatment to another atypical antipsychotic drug treatment by the decision of their physicians.
Who cannot join
- Patients who are pregnant or considering pregnancy.
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
Turkey (Türkiye)47 sites
Adana Psychiatry and Neurology Hospital
Adana
Cukurova University Scool of Medicine
Adana
Pfizer Investigational Site
Adana
Ankara Oncology Research and Training Hospital
Ankara, 06200
Pfizer Investigational Site
Ankara, 06200
Ankara Diskapi Training and Research Hospital
Ankara
Ankara Numune Research Hospital
Ankara
Ankara Numune Training and Research Hospital Department of Psychiatry
Ankara
Pfizer Investigational Site
Ankara
Antakya Mustafa Kemal University School of Medicine
Antakya
Pfizer Investigational Site
Antakya
Bolu Psychiatry and Neurology Hospital
Bolu
Pfizer Investigational Site
Bolu
Pamukkale University School Of Medicine
Denizli
Pfizer Investigational Site
Denizli
Elazig Mental Illness And Diseases Hospital
Elâzığ
Pfizer Investigational Site
Elâzığ
Eskisehir Osmangazi University
Eskişehir
Pfizer Investigational Site
Eskişehir
Bakirkoy Psychiatry and Neurology Hospital
Istanbul, 34147
Pfizer Investigational Site
Istanbul, 34147
Bakirkoy Mental Health Hospital, First Clinic of Neurosis
Istanbul
Bakirkoy Psychiatry and Neurology Hospital
Istanbul
Cerrahpasa School of Medicine
Istanbul
Erenkoy Psychology and neurology hospital
Istanbul
Istanbul University Istanbul School of Medicine
Istanbul
Marmara School of Medicine
Istanbul
Pfizer Investigational Site
Istanbul
Sisli Etfal Research and training Hospital
Istanbul
Vakif Gureba Hospital, Department of Psychiatry
Istanbul
Ege University School Of Medicine
Izmir
Pfizer Investigational Site
Izmir
Kayseri Public Hospital
Kayseri
Pfizer Investigational Site
Kayseri
Pfizer Investigational Site
Konya
Selcuk University Medical School Department of Psychiatry
Konya
Adana Psychiatry and Neurology Hospital
Kurttepe, Adana, 01360
Pfizer Investigational Site
Kurttepe, Adana, 01360
Manisa Mental Illness And Diseases Hospital
Manisa
Pfizer Investigational Site
Manisa
19 may University School of Medicine
Samsun
Pfizer Investigational Site
Samsun
Samsun Mental Illness And Diseases Hospital
Samsun
Pfizer Investigational Site
Trabzon
Trabzon Numune Research Hospital
Trabzon
Pfizer Investigational Site
Trakya
Trakya University School of Medicine
Trakya
About this study
Official title: A MULTI-CENTER, NON-INVASIVE OBSERVATIONAL STUDY OF METABOLIC SYNDROME PARAMETERS IN SCHIZOPHRENIC PATIENTS USING ATYPICAL ANTIPSYCHOTICS
The purpose of the study is to find and follow-up the metabolic syndrome parameters on patients administering atypical antipsychotics.
Read the detailed description
Sampling Method Details: Group of patients using the same atypical anti-psychotic.
- Conditions
- Schizophrenia, Metabolic Syndrome X
- Being tested
- No intervention
- Keywords
- Atypical antipsychotics, Metabolic syndrome, Safety
- Medical subject headings
- Schizophrenia, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Atypical Antispychotics (or second generation antipsychotics) | Patients with schizophrenia who are currently receiving or are going to start a new treatment with atypical antipsychotics, ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, amisulpride. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Syndrome Parameter Body Mass Index (BMI)
Iterative mean Body Mass Index at time points.
Measured: Baseline, 1 Month, 4 Months
Metabolic Syndrome Parameter Body Weight
Iterative measurement of body weight. Mean at time points.
Measured: Baseline, 1 Month, 4 Months
Metabolic Syndrome Parameter Waist Circumference
Iterative measurement of waist circumference. Mean at timepoints.
Measured: Baseline, 1 Month, 4 Months
Metabolic Syndrome Parameter Fasting Blood Sugar
Iterative measurement of fasting blood sugar. Mean at time points.
Measured: Baseline, 1 Month, 4 Months
Metabolic Syndrome Parameter Total Cholesterol
Iterative measurement of total cholesterol. Mean at time points.
Measured: Baseline, 1 Month, 4 Months
Metabolic Syndrome Parameter Low Density Lipoprotein (LDL)
Iterative measurement of LDL. Mean at time points
Measured: Baseline, 1 Month, 4 Months
Metabolic Syndrome Parameter High Density Lipoprotein (HDL)
Iterative measurement of HDL. Mean at time points
Measured: Baseline, 1 Month, 4 Months
Metabolic Syndrome Parameter Triglycerides
Iterative measurement of triglycerides. Mean at time points
Measured: Baseline, 1 Month, 4 Months
Secondary outcomes (4)
Metabolic Syndrome Parameter BMI by Treatment Group
Iterative measurement of BMI. Mean at time points.
Measured: Baseline, 1 Month, 4 Months
Metabolic Syndrome Parameter Weight by Treatment Group
Iterative measurement of weight. Mean at time points.
Measured: Baseline, 1 Month, 4 Months
Metabolic Syndrome Parameter Waist Circumference by Treatment Group
Iterative measurement of waist circumference. Mean at time points.
Measured: Baseline, 1 Month, 4 Months
Metabolic Syndrome Parameter Triglycerides by Treatment Group
Iterative measurement of triglycerides. Mean at time points.
Measured: Baseline, 1 Month, 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2007 (estimated)
- Study start23 Oct 2007
- Primary completion30 Jul 2008
- Study completion30 Jul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448630
- Sponsor's protocol ID
- A1281160
- Acronym
- MESSAGE
- Status last verified
- Apr 2022
- First submitted
- 16 Mar 2007
- Last updated
- 3 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A MULTI-CENTER, NON-INVASIVE OBSERVATIONAL STUDY OF METABOLIC SYNDROME PARAMETERS IN SCHIZOPHRENIC PATIENTS USING ATYPICAL ANTIPSYCHOTICS
- ClinicalTrials.gov ID
- NCT00448630
- Acronym / sponsor ID
- MESSAGE / A1281160
- Conditions
- Schizophrenia, Metabolic Syndrome X
- Keywords
- Atypical antipsychotics, Metabolic syndrome, Safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Oct 2007 (actual)
- Primary completion
- 30 Jul 2008 (actual)
- Study completion
- 30 Jul 2008 (actual)
- First posted
- 19 Mar 2007 (estimated)
- Results
- Posted 7 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to find and follow-up the metabolic syndrome parameters on patients administering atypical antipsychotics.
Detailed description
Sampling Method Details: Group of patients using the same atypical anti-psychotic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atypical Antispychotics (or second generation antipsychotics) | – | Other: No interventionPatients with schizophrenia who are currently receiving or are going to start a new treatment with atypical antipsychotics, ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, amisulpride. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- * Female and male patients diagnosed as schizophrenia by DSM-IV criteria; Age between 18-45 years * Patients who started atypical antipsychotic drug treatment or patients who switched from the previous conventional or atypical antipsychotic treatment to another atypical antipsychotic drug treatment by the decision of their physicians in psychiatry clinics in state and university hospitals.
Key inclusion criteria (3 listed)
- Female and male patients diagnosed as schizophrenia by the Diagnostic and Statistical Manual of Mental Disorders.
- Age between 18-45 years
- Patients who started atypical antipsychotic drug treatment or patients who switched from the previous conventional or atypical antipsychotic treatment to another atypical antipsychotic drug treatment by the decision of their physicians.
Key exclusion criteria (1 listed)
- Patients who are pregnant or considering pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNon-interventional study | Other | Atypical Antispychotics (or second generation antipsychotics) |
Primary outcome
Metabolic Syndrome Parameter Body Mass Index (BMI)
Time frame: Baseline, 1 Month, 4 Months
Iterative mean Body Mass Index at time points.
Metabolic Syndrome Parameter Body Weight
Time frame: Baseline, 1 Month, 4 Months
Iterative measurement of body weight. Mean at time points.
Metabolic Syndrome Parameter Waist Circumference
Time frame: Baseline, 1 Month, 4 Months
Iterative measurement of waist circumference. Mean at timepoints.
Metabolic Syndrome Parameter Fasting Blood Sugar
Time frame: Baseline, 1 Month, 4 Months
Iterative measurement of fasting blood sugar. Mean at time points.
Metabolic Syndrome Parameter Total Cholesterol
Time frame: Baseline, 1 Month, 4 Months
Iterative measurement of total cholesterol. Mean at time points.
Metabolic Syndrome Parameter Low Density Lipoprotein (LDL)
Time frame: Baseline, 1 Month, 4 Months
Iterative measurement of LDL. Mean at time points
Metabolic Syndrome Parameter High Density Lipoprotein (HDL)
Time frame: Baseline, 1 Month, 4 Months
Iterative measurement of HDL. Mean at time points
Metabolic Syndrome Parameter Triglycerides
Time frame: Baseline, 1 Month, 4 Months
Iterative measurement of triglycerides. Mean at time points
4 secondary outcomes
Metabolic Syndrome Parameter BMI by Treatment Group
Time frame: Baseline, 1 Month, 4 Months
Metabolic Syndrome Parameter Weight by Treatment Group
Time frame: Baseline, 1 Month, 4 Months
Metabolic Syndrome Parameter Waist Circumference by Treatment Group
Time frame: Baseline, 1 Month, 4 Months
Metabolic Syndrome Parameter Triglycerides by Treatment Group
Time frame: Baseline, 1 Month, 4 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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.
Pfizer CT.gov Call Center study director
Pfizer
47 sites 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 Metabolic Syndrome X, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 47 sites in Turkey (Türkiye).
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 3 inclusion and 1 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 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in Turkey (Türkiye). 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?
Yes. Results are posted in the registry (first posted 7 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Metabolic Syndrome Parameter Body Mass Index (BMI) (time frame: Baseline, 1 Month, 4 Months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2022; AzTrials last refreshed its copy on 7 Nov 2026.