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

Last updated on November 7, 2019

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

NCT00448630
Pfizer
Completed
An Observational Study On Metabolic Syndrome Parameters In Schizophrenia Patients Treated With Atypical Antipsychotics

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Descriptive Information
Brief TitleAn Observational Study On Metabolic Syndrome Parameters In Schizophrenia Patients Treated With Atypical Antipsychotics
Official TitleA Multi-Center, Non-Interventional, Observational Study On Metabolic Syndrome Parameters In Schizophrenia Patients Treated With Atypical Antipsychotics
Brief SummaryThe purpose of the study is to find and follow-up the metabolic syndrome parameters on patients administering atypical antipsychotics.
Detailed DescriptionSampling Method Details: Group of patients using the same atypical anti-psychotic.
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenRetention:   Samples With DNA
Description:
Whole blood (fasting blood glucose, total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride levels)
Sampling MethodNon-Probability Sample
Study PopulationFemale 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
InterventionOther: No intervention
Non-interventional study
Study Groups/CohortsAtypical 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 StatusCompleted
Actual Enrollment
 (submitted: June 4, 2010)
328
Original Enrollment
 (submitted: March 16, 2007)
450
Actual Study Completion DateJuly 2008
Actual Primary Completion DateJuly 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
Ages18 Years to 45 Years   (Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesTurkey
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00448630
Other Study ID NumbersA1281160
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer Inc
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2010

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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