NCT00178932

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Nov 1998

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1998

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
18.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2024

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

25.6 years

First QC Date

September 12, 2005

Last Update Submit

March 13, 2025

Conditions

SchizophreniaSchizoaffective DisorderBipolar DisorderMajor Depression

Outcome Measures

Primary Outcomes (1)

  • We plan to compare the polymorphisms across schizophrenic patients and adults who do not have a diagnosed major mental illness. .

    single visit

Secondary Outcomes (1)

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

    single visit

Study Arms (2)

1 Outcome in schizophrenia with certain antipsychotic

ACTIVE COMPARATOR

clozapine

Procedure: genetic analysisProcedure: genetic assay

2 Outcome in schizophrenia with other Antipsychotics

ACTIVE COMPARATOR

Other Antipsychotics

Procedure: genetic analysisProcedure: genetic assay

Interventions

genetic analysisPROCEDURE

genetic assay of blood sample drawn with patient's consent

1 Outcome in schizophrenia with certain antipsychotic2 Outcome in schizophrenia with other Antipsychotics
genetic assayPROCEDURE

genetic assay of blood sample drawn with patient's consent

1 Outcome in schizophrenia with certain antipsychotic2 Outcome in schizophrenia with other Antipsychotics

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatric Hospital at Vanderbilt

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersBipolar DisorderDepressive Disorder, Major

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood DisordersDepressive Disorder

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health Services

Study Officials

  • Herbert Y Meltzer, M.D.

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

November 1, 1998

Primary Completion

May 16, 2024

Study Completion

May 16, 2024

Last Updated

March 18, 2025

Record last verified: 2025-03

Locations

US(1)