SchizophreniaNCT00666432
Bipolar and Schizophrenia Consortium for Parsing Intermediate Phenotypes
An observational study of Schizophrenia and Bipolar, run by University of Maryland, Baltimore at 6 sites in United States.
Trial summary
Briefly, this multisite study is designed to identify endophenotypes (i.e., heritable biomarkers) associated with either schizophrenia or bipolar disorder alone, or both together. The subsequent genetic analyses will search genomic loci and candidate genes associated with each of the independent endophenotypes. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Bipolar
- What is being tested?
- This is an observational study model that is family based
- How many people
- 3,500 participants
- Where
- 6 sitesUnited States
- Study dates
- May 2008to 22 Nov 2019
- Phase
- Observational
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Subjects will be recruited from the University of Maryland, Community Mental Health Center and Private Psychiatrists.
Who may be able to join
- Male and female participants 15 years of age and above.
- Case probands will include individuals who meet DSM-IV criteria for schizophrenia, schizoaffective, or bipolar disorder with psychosis
Who cannot join
- Control subjects who meet DSM-IV criteria for any lifetime psychotic illness or BP, or have a family history of psychotic or BP disorders in their first or second-degree relatives will be excluded.
- A number of exclusions are necessary because they potentially affect neurophysiological measures. Exclusions will be applied to all groups to maintain consistency in recruitment. As a result, the following individuals will be excluded:
- Subjects under 15 years of age will be excluded. Subjects with serious medical, neuro-ophthalmological or neurological illness (e.g., cancer, seizure disorders, encephalopathy) will be excluded, with the exception of family member subjects participating for clinical interview and blood sample only.
- Subjects with current substance abuse (within 6 months), dependence within 2 years or extensive history of drug dependence will be excluded, with the exception of family member subjects participating for clinical interview and blood sample only.
- Subjects with mental retardation will be excluded, with the exception of family member subjects participating for clinical interview and blood sample only.
- Subjects with ferromagnetic objects lodged in body will be excluded, with the exception of family member subjects participating for clinical interview and blood sample only.
- Schizophrenic patients who are judged to be incompetent to provide voluntary informed consent based on the ESC evaluation.
- Any participant who would require an x-ray to rule out the presence of metal in their body prior to an MRI scan
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Johns Hopkins School of Medicine
Baltimore, Maryland, 21201
University of Maryland, Baltimore
Baltimore, Maryland, 21228
Center for Cognitive Medicine
Chicago, Illinois, 60612
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Wayne State University School of Medicine
Detroit, Michigan, 48201
Hartford Hospital- The Institute of Living
Hartford, Connecticut, 06106
About this study
Briefly, this multisite study is designed to identify endophenotypes (i.e., heritable biomarkers) associated with either schizophrenia or bipolar disorder alone, or both together. The subsequent genetic analyses will search genomic loci and candidate genes associated with each of the independent endophenotypes. This is a five site study that is slotted for NIMH funding.
Read the detailed description
We propose to recruit 100 case probands with a diagnosis of SZ, 100 case probands with a diagnosis of BP Disorder I with history of psychosis; BPI-P) and 400 1st degree case relatives. All 1st degree family members who are willing to participate will provide clinical information and blood sample, only a proportion will be eligible for endophenotypic studies). Individuals with psychotic disorder not otherwise specified are also eligible for testing. Their data will be incorporated with the schizophrenia or bipolar data upon confirmation of diagnosis. Family members of individuals with psychotic disorder not otherwise specified will not be tested unless the individual has a later confirmed diagnosis of schizophrenia or bipolar disorder. Probands will not be tested during the acute phase of the illness as judged clinically e.g., significant increase in core symptoms from their stable baseline that requires a change in treatment such increased dose of medication, drug change, or hospitalization). As part of another existing protocol, we have collected most of the endophynotypic information in schizophrenia probands and 1st degree relatives other than brain imaging and few other tests. We will attempt to recruit these subjects to complete the imaging studies and the data will be used in the current study.
We will recruit 100 healthy comparison subjects from the community in order to describe the distribution of normal values for our endophenotype procedures in a demographically matched sample. The SZ and BPI-P probands, and 50 healthy control subjects, will be frequency matched on age, sex ratio, and head of the household's socio-economic status (SES). Another group of 50 healthy control subjects will be similarly matched to the relative groups recruited.
Participants will undergo a number of clinical, electrophysiological, structural brain imaging, perceptual, and cognitive assessments. These data will be used to identify phenotypes likely to be associated with genetic risk for schizophrenia and/or bipolar disorder, and to determine how these phenotypes aggregate in families. Some of the analyses will focus on examining associations between candidate genes and these alternative phenotypes. Thus if we are not able to recruit relatives we may still collect these phenotypic data in probands and their genetic sample for future genotype/phenotype association studies. Family members may elect to participate only in the clinical and blood draw portions of the study. Testing procedures require a 12 -15 hour time commitment and testing will be completed over 2 or more days. Participants will be asked to give a blood (or saliva if difficult to obtain blood sample for instance because of fear of blood draws), which will be stored for future genetic analyses. Data from the previous family study will be combined with the data collected in this protocol for some of the analyses.
- Conditions
- Schizophrenia, Bipolar
- Being tested
- This is an observational study model that is family based
- Keywords
- schizophrenia, bipolar, eye movements, phenotype, biochemical, relatives
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is an observational study model that is family basedOther
This is an observational study model that is family based
| Study group | Role | What they receive |
|---|---|---|
| 1 | Controls Receives: Other: This is an observational study model that is family based | |
| 2 | Patient Family Receives: Other: This is an observational study model that is family based | |
| 3 | Patients Receives: Other: This is an observational study model that is family based |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smooth pursuit eye movement measures; P50 gating; PPI; Cognitive measures; P300 component of evoked potential; genetic markers
Measured: 10-13 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionSep 2012
- Study completion22 Nov 2019
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.
- 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
- Observational
- Observational model
- Family based
- Time perspective
- Other
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, MPRC, University of Maryland, Baltimore
- Investigators
- Liyi E Hong, M.D., Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666432
- Sponsor's protocol ID
- HP-00043960
- Other IDs
- R01MH077852
- Status last verified
- Apr 2021
- First submitted
- 21 Apr 2008
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bipolar and Schizophrenia Consortium for Parsing Intermediate Phenotypes
- ClinicalTrials.gov ID
- NCT00666432
- Acronym / sponsor ID
- HP-00043960
- Conditions
- Schizophrenia, Bipolar
- Keywords
- schizophrenia, bipolar, eye movements, phenotype, biochemical, relatives
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 2008
- Primary completion
- Sep 2012 (actual)
- Study completion
- 22 Nov 2019 (actual)
- First posted
- 24 Apr 2008 (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.
Briefly, this multisite study is designed to identify endophenotypes (i.e., heritable biomarkers) associated with either schizophrenia or bipolar disorder alone, or both together. The subsequent genetic analyses will search genomic loci and candidate genes associated with each of the independent endophenotypes. This is a five site study that is slotted for NIMH funding.
Detailed description
We propose to recruit 100 case probands with a diagnosis of SZ, 100 case probands with a diagnosis of BP Disorder I with history of psychosis; BPI-P) and 400 1st degree case relatives. All 1st degree family members who are willing to participate will provide clinical information and blood sample, only a proportion will be eligible for endophenotypic studies). Individuals with psychotic disorder not otherwise specified are also eligible for testing. Their data will be incorporated with the schizophrenia or bipolar data upon confirmation of diagnosis. Family members of individuals with psychotic disorder not otherwise specified will not be tested unless the individual has a later confirmed diagnosis of schizophrenia or bipolar disorder. Probands will not be tested during the acute phase of the illness as judged clinically e.g., significant increase in core symptoms from their stable baseline that requires a change in treatment such increased dose of medication, drug change, or hospitalization). As part of another existing protocol, we have collected most of the endophynotypic information in schizophrenia probands and 1st degree relatives other than brain imaging and few other tests. We will attempt to recruit these subjects to complete the imaging studies and the data will be used in the current study.
We will recruit 100 healthy comparison subjects from the community in order to describe the distribution of normal values for our endophenotype procedures in a demographically matched sample. The SZ and BPI-P probands, and 50 healthy control subjects, will be frequency matched on age, sex ratio, and head of the household's socio-economic status (SES). Another group of 50 healthy control subjects will be similarly matched to the relative groups recruited.
Participants will undergo a number of clinical, electrophysiological, structural brain imaging, perceptual, and cognitive assessments. These data will be used to identify phenotypes likely to be associated with genetic risk for schizophrenia and/or bipolar disorder, and to determine how these phenotypes aggregate in families. Some of the analyses will focus on examining associations between candidate genes and these alternative phenotypes. Thus if we are not able to recruit relatives we may still collect these phenotypic data in probands and their genetic sample for future genotype/phenotype association studies. Family members may elect to participate only in the clinical and blood draw portions of the study. Testing procedures require a 12 -15 hour time commitment and testing will be completed over 2 or more days. Participants will be asked to give a blood (or saliva if difficult to obtain blood sample for instance because of fear of blood draws), which will be stored for future genetic analyses. Data from the previous family study will be combined with the data collected in this protocol for some of the analyses.
Study design
- Observational model
- Family based
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: This is an observational study model that is family basedControls |
| 2 | – | Other: This is an observational study model that is family basedPatient Family |
| 3 | – | Other: This is an observational study model that is family basedPatients |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects will be recruited from the University of Maryland, Community Mental Health Center and Private Psychiatrists.
Key inclusion criteria (2 listed)
- Male and female participants 15 years of age and above.
- Case probands will include individuals who meet DSM-IV criteria for schizophrenia, schizoaffective, or bipolar disorder with psychosis
Key exclusion criteria (8 listed)
- Control subjects who meet DSM-IV criteria for any lifetime psychotic illness or BP, or have a family history of psychotic or BP disorders in their first or second-degree relatives will be excluded.
- A number of exclusions are necessary because they potentially affect neurophysiological measures. Exclusions will be applied to all groups to maintain consistency in recruitment. As a result, the following individuals will be excluded:
- Subjects under 15 years of age will be excluded. Subjects with serious medical, neuro-ophthalmological or neurological illness (e.g., cancer, seizure disorders, encephalopathy) will be excluded, with the exception of family member subjects participating for clinical interview and blood sample only.
- Subjects with current substance abuse (within 6 months), dependence within 2 years or extensive history of drug dependence will be excluded, with the exception of family member subjects participating for clinical interview and blood sample only.
- Subjects with mental retardation will be excluded, with the exception of family member subjects participating for clinical interview and blood sample only.
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 |
|---|---|---|
| This is an observational study model that is family basedThis is an observational study model that is family based | Other | 1, 2, 3 |
Primary outcome
Smooth pursuit eye movement measures; P50 gating; PPI; Cognitive measures; P300 component of evoked potential; genetic markers
Time frame: 10-13 hrs
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 3 May 2021.
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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.
Liyi E Hong, M.D. principal investigator
University of Maryland, Baltimore
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Bipolar, run by University of Maryland, Baltimore at 6 sites 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 2 inclusion and 8 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 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Smooth pursuit eye movement measures; P50 gating; PPI; Cognitive measures; P300 component of evoked potential; genetic markers (time frame: 10-13 hrs). 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 3 May 2021.