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CompletedNCT00178932Updated Mar 18, 2025

Improving Outcome in Schizophrenia Through Identification of Genetic Risk Factors

An interventional study of genetic analysis and genetic assay in Schizophrenia, Schizoaffective Disorder and Bipolar Disorder, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-18.

Sponsored by Northwestern University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 6 years 10 months after the study started (first participant enrolled Nov 1998, registered Sep 2005).
Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The goals of this study are to replicate previous findings of genetic predictors of response to clozapine and other antipsychotic drugs.

02

Conditions studied

  • Schizophrenia
  • Schizoaffective Disorder
  • Bipolar Disorder
  • Major Depression
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 37 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Active comparator
    1 Outcome in schizophrenia with certain antipsychotic

    clozapine

    Procedure: genetic analysis · Procedure: genetic assay

  • Active comparator
    2 Outcome in schizophrenia with other Antipsychotics

    Other Antipsychotics

    Procedure: genetic analysis · Procedure: genetic assay

Interventions

  • Proceduregenetic analysis

    genetic assay of blood sample drawn with patient's consent

  • Proceduregenetic assay

    genetic assay of blood sample drawn with patient's consent

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. We will also evaluate relationships between the polymorphism and past and current mental health among the non-diagnosed sample

    Time frame: single visit

07

Study locations

1 site
  • Psychiatric Hospital at Vanderbilt
    Nashville, Tennessee 37212, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00178932
Lead sponsor
Northwestern University
Responsible party
Sponsor
First posted
Sep 15, 2005
Start date
Nov 1998
Primary completion
May 16, 2024
Completion
May 16, 2024
Last update
Mar 18, 2025

Study contacts

Herbert Y Meltzer, M.D.
principal investigator · Vanderbilt University Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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