Back to resultsImproving Outcome in Schizophrenia Through Identification of Genetic Risk Factors
Primary Purpose
Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
genetic analysis
genetic assay
Sponsored by
About this trial
This is an interventional diagnostic trial for Schizophrenia
Eligibility 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.
Sites / Locations
- Psychiatric Hospital at VanderbiltRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1 Outcome in schizophrenia with certain antipsychotic
2 Outcome in schizophrenia with other Antipsychotics
Arm Description
clozapine
Other Antipsychotics
Outcomes
Primary Outcome Measures
We plan to compare the polymorphisms across schizophrenic patients and adults who do not have a diagnosed major mental illness. .
Secondary Outcome Measures
We will also evaluate relationships between the polymorphism and past and current mental health among the non-diagnosed sample
Full Information
NCT ID
NCT00178932
First Posted
September 12, 2005
Last Updated
April 3, 2023
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT00178932
Brief Title
Improving Outcome in Schizophrenia Through Identification of Genetic Risk Factors
Official Title
Improving Outcome in Schizophrenia Through Identification of Genetic Risk Factors
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1998 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goals of this study are to replicate previous findings of genetic predictors of response to clozapine and other antipsychotic drugs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major Depression
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1 Outcome in schizophrenia with certain antipsychotic
Arm Type
Active Comparator
Arm Description
clozapine
Arm Title
2 Outcome in schizophrenia with other Antipsychotics
Arm Type
Active Comparator
Arm Description
Other Antipsychotics
Intervention Type
Procedure
Intervention Name(s)
genetic analysis
Intervention Description
genetic assay of blood sample drawn with patient's consent
Intervention Type
Procedure
Intervention Name(s)
genetic assay
Intervention Description
genetic assay of blood sample drawn with patient's consent
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
We will also evaluate relationships between the polymorphism and past and current mental health among the non-diagnosed sample
Time Frame
single visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barrett Share, M.A.
Phone
615-936-6796
Email
daniel.b.share@vanderbilt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert Y Meltzer, M.D.
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatric Hospital at Vanderbilt
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kara L Watts, M.A.
Phone
615-343-9717
Email
kara.l.watts@vanderbilt.edu
First Name & Middle Initial & Last Name & Degree
Herbert Y Meltzer, M.D.
12. IPD Sharing Statement
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Improving Outcome in Schizophrenia Through Identification of Genetic Risk Factors
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