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Improving Outcome in Schizophrenia Through Identification of Genetic Risk Factors

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2010 by Vanderbilt University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00178932
First Posted: September 15, 2005
Last Update Posted: November 3, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Vanderbilt University
  Purpose
The goals of this study are to replicate previous findings of genetic predictors of response to clozapine and other antipsychotic drugs.

Condition Intervention
Schizophrenia Schizoaffective Disorder Bipolar Disorder Major Depression Procedure: genetic analysis Procedure: genetic assay

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Improving Outcome in Schizophrenia Through Identification of Genetic Risk Factors

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • We plan to compare the polymorphisms across schizophrenic patients and adults who do not have a diagnosed major mental illness. . [ Time Frame: single visit ]

Secondary Outcome Measures:
  • We will also evaluate relationships between the polymorphism and past and current mental health among the non-diagnosed sample [ Time Frame: single visit ]

Estimated Enrollment: 1000
Study Start Date: November 1998
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: genetic analysis
    genetic assay of blood sample drawn with patient's consent
    Procedure: genetic assay
    genetic assay of blood sample drawn with patient's consent
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patients with the diagnoses of schizophrenia or schizoaffective disorder, and bipolar disorder or major depression with psychotic features, or volunteers with no history of a psychotic disorder.

Exclusion Criteria:

Patients with DSM-IV diagnoses other than schizophrenia or schizoaffective disorder, and bipolar disorder or major depression with psychotic features.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00178932


Contacts
Contact: Barrett Share, M.A. 615-936-6796 daniel.b.share@vanderbilt.edu

Locations
United States, Tennessee
Psychiatric Hospital at Vanderbilt Recruiting
Nashville, Tennessee, United States, 37212
Contact: Kara L Watts, M.A.    615-343-9717    kara.l.watts@vanderbilt.edu   
Principal Investigator: Herbert Y Meltzer, M.D.         
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Herbert Y Meltzer, M.D. Vanderbilt University Medical Center
  More Information

Responsible Party: Herbert Meltzer, M.D., Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00178932     History of Changes
Other Study ID Numbers: 9132
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: November 3, 2010
Last Verified: November 2010

Additional relevant MeSH terms:
Disease
Schizophrenia
Bipolar Disorder
Depressive Disorder, Major
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders
Depressive Disorder
Mood Disorders