SchizophreniaNCT00178932
Improving Outcome in Schizophrenia Through Identification of Genetic Risk Factors
A study testing genetic analysis and genetic assay in people with Schizophrenia and Schizoaffective Disorder, run by Northwestern University at 1 site in United States.
Trial summary
The goals of this study are to replicate previous findings of genetic predictors of response to clozapine and other antipsychotic drugs. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
- What is being tested?
- genetic analysis and genetic assay
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1998to 16 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with DSM-IV diagnoses other than schizophrenia or schizoaffective disorder, and bipolar disorder or major depression with psychotic features.
Trial locations and contacts
1 site in 1 country.
United States1 site
Psychiatric Hospital at Vanderbilt
Nashville, Tennessee, 37212
About this study
The goals of this study are to replicate previous findings of genetic predictors of response to clozapine and other antipsychotic drugs.
- Being tested
- genetic analysis, genetic assay
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Bipolar Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genetic analysisProcedure or surgery
genetic assay of blood sample drawn with patient's consent
genetic assayProcedure or surgery
genetic assay of blood sample drawn with patient's consent
| Study group | Role | What they receive |
|---|---|---|
| 1 Outcome in schizophrenia with certain antipsychotic | Active comparator | clozapine Receives: Procedure: genetic analysis; Procedure: genetic assay |
| 2 Outcome in schizophrenia with other Antipsychotics | Active comparator | Other Antipsychotics Receives: Procedure: genetic analysis; Procedure: genetic assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
We plan to compare the polymorphisms across schizophrenic patients and adults who do not have a diagnosed major mental illness. .
Measured: single visit
Secondary outcomes (1)
We will also evaluate relationships between the polymorphism and past and current mental health among the non-diagnosed sample
Measured: single visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startNov 1998
- Primary completion16 May 2024
- Study completion16 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Herbert Y Meltzer, M.D., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00178932
- Sponsor's protocol ID
- 9132
- Status last verified
- Mar 2025
- First submitted
- 12 Sep 2005
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Outcome in Schizophrenia Through Identification of Genetic Risk Factors
- ClinicalTrials.gov ID
- NCT00178932
- Acronym / sponsor ID
- 9132
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Nov 1998 (actual)
- Primary completion
- 16 May 2024 (actual)
- Study completion
- 16 May 2024 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goals of this study are to replicate previous findings of genetic predictors of response to clozapine and other antipsychotic drugs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Outcome in schizophrenia with certain antipsychotic | Active comparator | Procedure: genetic analysis, Procedure: genetic assayclozapine |
| 2 Outcome in schizophrenia with other Antipsychotics | Active comparator | Procedure: genetic analysis, Procedure: genetic assayOther Antipsychotics |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with DSM-IV diagnoses other than schizophrenia or schizoaffective disorder, and bipolar disorder or major depression with psychotic features.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| genetic analysisgenetic assay of blood sample drawn with patient's consent | Procedure or surgery | 1 Outcome in schizophrenia with certain antipsychotic, 2 Outcome in schizophrenia with other Antipsychotics |
| genetic assaygenetic assay of blood sample drawn with patient's consent | Procedure or surgery | 1 Outcome in schizophrenia with certain antipsychotic, 2 Outcome in schizophrenia with other Antipsychotics |
Primary outcome
We plan to compare the polymorphisms across schizophrenic patients and adults who do not have a diagnosed major mental illness. .
Time frame: single visit
1 secondary outcome
We will also evaluate relationships between the polymorphism and past and current mental health among the non-diagnosed sample
Time frame: single visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herbert Y Meltzer, M.D. principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing genetic analysis and genetic assay in people with Schizophrenia and Schizoaffective Disorder, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
We plan to compare the polymorphisms across schizophrenic patients and adults who do not have a diagnosed major mental illness. . (time frame: single visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.