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Improving Outcome in Schizophrenia Through Identification of Genetic Risk Factors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Vanderbilt University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00178932
First received: September 12, 2005
Last updated: November 1, 2010
Last verified: November 2010
History of Changes
  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: Open Label
Primary Purpose: Diagnostic
Official Title: Improving Outcome in Schizophrenia Through Identification of Genetic Risk Factors

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Herbert Meltzer, M.D., Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00178932     History of Changes
Other Study ID Numbers: 9132
Study First Received: September 12, 2005
Last Updated: November 1, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Psychotic Disorders
Schizophrenia
Depressive Disorder, Major
 Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 19, 2013