Bipolar and Schizophrenia Consortium for Parsing Intermediate Phenotypes

NCT00666432 | Completed DMC

• 2 other identifiers: HP-00043960R01MH077852
• Study Type: observational
• Target: 3,500
• Locations: 1 country
• Sites: 6

Brief 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. This is a five site study that is slotted for NIMH funding.

Conditions

Schizophrenia; Bipolar

Keywords

schizophrenia; bipolar; eye movements; phenotype; biochemical; relatives

Outcome Measures

Primary Outcomes (1)

• Smooth pursuit eye movement measures; P50 gating; PPI; Cognitive measures; P300 component of evoked potential; genetic markers

  10-13 hrs

Study Arms (3)

1

Controls

Other: This is an observational study model that is family based

2

Patient Family

Other: This is an observational study model that is family based

3

Patients

Other: This is an observational study model that is family based

Interventions

This is an observational study model that is family based OTHER

This is an observational study model that is family based

1; 2; 3

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from the University of Maryland, Community Mental Health Center and Private Psychiatrists.

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (6)

Hartford Hospital- The Institute of Living

Hartford, Connecticut, 06106, United States

Location

Center for Cognitive Medicine

Chicago, Illinois, 60612, United States

Location

Johns Hopkins School of Medicine

Baltimore, Maryland, 21201, United States

Location

University of Maryland, Baltimore

Baltimore, Maryland, 21228, United States

Location

Wayne State University School of Medicine

Detroit, Michigan, 48201, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood or saliva will be stored for future genetic analysis.

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Liyi E Hong, M.D.

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: L.E. Hong

Study Record Dates

• First Submitted: April 21, 2008
• First Posted: April 24, 2008
• Study Start: May 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: November 22, 2019
• Last Updated: May 3, 2021

Record last verified: 2021-04

Locations

US (6)