An Observational Study On Metabolic Syndrome Parameters In Schizophrenia Patients Treated With Atypical Antipsychotics

NCT00448630

Last updated date
Study Location
Pfizer Investigational Site
Kurttepe, Adana, 01360, Turkey
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia, Metabolic Syndrome X
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-45 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Patients who are pregnant or considering pregnancy.


- Patients who were included in a similar study

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Schizophrenia, Metabolic Syndrome XAn Observational Study On Metabolic Syndrome Parameters In Schizophrenia Patients Treated With Atypical Antipsychotics NCT00448630
  1. Kurttepe, Adana
  2. Adana,
  3. Ankara,
  4. Ankara,
  5. Antakya,
  6. Bolu,
  7. Denizli,
  8. Elazig,
  9. Eskisehir,
  10. Istanbul,
  11. Istanbul,
  12. Izmir,
  13. Kayseri,
  14. Konya,
  15. Manisa,
  16. Samsun,
  17. Trabzon,
  18. Trakya,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title An Observational Study On Metabolic Syndrome Parameters In Schizophrenia Patients Treated With Atypical Antipsychotics
Official Title A Multi-Center, Non-Interventional, Observational Study On Metabolic Syndrome Parameters In Schizophrenia Patients Treated With Atypical Antipsychotics
Brief Summary 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood (fasting blood glucose, total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride levels)
Sampling Method Non-Probability Sample
Study Population Female and male patients diagnosed as schizophrenia by DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) 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.
Condition
  • Schizophrenia
  • Metabolic Syndrome X
Intervention Other: No intervention
Non-interventional study
Study Groups/Cohorts 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.
Intervention: Other: No intervention
Publications * Not Provided

*   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: June 4, 2010)
328
Original Enrollment
 (submitted: March 16, 2007)
450
Actual Study Completion Date July 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients who are pregnant or considering pregnancy.
  • Patients who were included in a similar study
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT00448630
Other Study ID Numbers A1281160
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2010