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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

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 groups in NCT00666432
Study groupRoleWhat they receive
1Controls
Receives: Other: This is an observational study model that is family based
2Patient Family
Receives: Other: This is an observational study model that is family based
3Patients
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.

  1. 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.

  1. First posted24 Apr 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionSep 2012
  4. Study completion22 Nov 2019

Resources

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)
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

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.

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Clinical Trial NCT00666432 | AzTrials