Neurophysiological Studies in Schizophrenia and Psychiatric Disorders (BSNIP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Texas Southwestern Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Carol A. Tamminga, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01384604
First received: June 27, 2011
Last updated: June 21, 2012
Last verified: June 2012
  Purpose

The overall goal of this project is to identify intermediate phenotypes for psychosis across the schizophrenia and bipolar disorders boundary with implications for future genetic studies. Recent studies provide considerable evidence that schizophrenia and psychotic bipolar disorder may share overlapping etiologic determinants. Identifying disease-related genetic effects is a major focus in schizophrenia and bipolar research, with enormous implications for diagnosis and treatment for these two disorders. Efforts have been multifaceted, with the ultimate goal of describing causal paths from specific genetic variants, to changes in neuronal functioning, to altered brain anatomy, to behavioral and functional impairments. Parallel efforts have identified and refined several alternative endophenotypes that are stable, heritable, have (partly) known biological substrates, and are associated with psychosis liability. Although many such endophenotypes have been individually studied in schizophrenia, and to a lesser extent in bipolar disorder, no study has comprehensively assessed a broad panel of these markers in the two disorders with parallel recruitment, and the extent to which they mark independent aspects of psychosis risk, or their overlap in the two disorders. In this research project, we will examine a broad panel of putative endophenotypes in affected individuals and their first degree, biological relatives in order to: 1) characterize the degree of familial phenotypic overlap between schizophrenia and psychotic bipolar disorders; 2) identify patterns of endophenotypes unique to the two disorders; and, 3) contrast the heritability of endophenotypes across the disorders. We will obtain measures of neurophysiology (e.g., eye tracking, P50 gating, PPI, and P300), neurocognition (e.g., attention/vigilance, episodic and working memory), and brain structure (e.g., volumes of gray and white matter in specified brain regions). Blood samples will also be collected and stored for formal DNA linkage analyses using the independent phenotypes identified above. All volunteers will also be given the option to donate dermal biopsies for future research studies.

Establishing similarities and differences in the endophenotypic signatures within schizophrenia and bipolar families will provide important insights for future genetic studies, and clarify concepts about common and distinct aspects of pathophysiology, potentially meaningful heterogeneity with disorders, and the clinical boundaries of the two most common psychotic disorders in adult psychiatry. This line of investigation will potentially impact our conceptualization of psychotic disorders, help us make critical strides to identify the pathophysiology of psychosis, and guide development of new specific treatments targeting particular deficits.


Condition
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Cross-Sectional
Official Title: Neurophysiological and Genetic Studies in Schizophrenia and Other Psychiatric Disorders

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Biospecimen Retention:   Samples With DNA

Blood, no more than 30cc; urine, small collection cup (about 30cc) to administer drug urine screen and pregnancy tests for females; buccal swabs (at least 5 swabs from volunteers that cannot donate blood); and, optional: 4mm punch of skin for dermal biopsy.


Estimated Enrollment: 1189
Study Start Date: December 2007
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   15 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Individuals with schizophrenia, schizoaffective, or bipolar I disorder.

Criteria

Inclusion Criteria:

  • DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder with psychotic features
  • Ages 15-70 years old
  • Must have a first degree, biological relative in the same age range who is willing and available to participate

Exclusion Criteria:

  • Diagnosis of an organic brain disease
  • Meets criteria for alcohol or substance abuse with the last month; alcohol or substance dependence within the last 3 months; or, has an extensive history of drug dependence
  • History of seizures, serious head injury, concussions, or other evidence of brain disease
  • Medical illnesses that are not currently well-controlled
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01384604

Contacts
Contact: Carol A Tamminga, MD 214-645-2789 Carol.Tamminga@utsouthwestern.edu
Contact: Debra Moore Bushong, MS, LPC 214-648-4653 Debra.Bushong@UTSouthwestern.edu

Locations
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Carol A Tamminga, MD    214-645-2789    Carol.Tamminga@utsouthwestern.edu   
Contact: Debra Moore Bushong, MS, LPC    214-648-4653    Debra.Bushong@utsouthwestern.edu   
Principal Investigator: Carol A Tamminga, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Carol A. Tamminga, Principal Investigator, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01384604     History of Changes
Other Study ID Numbers: STU 112010-097, 1R01MH077851-01A2
Study First Received: June 27, 2011
Last Updated: June 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Schizophrenia
Schizoaffective disorder
Bipolar disorder
Psychosis
Genetics
Phenotype

Additional relevant MeSH terms:
Bipolar Disorder
Disease
Mental Disorders
Psychotic Disorders
Schizophrenia
Affective Disorders, Psychotic
Mood Disorders
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on October 23, 2014