Neurophysiological Studies in Schizophrenia and Psychiatric Disorders (BSNIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01384604
Recruitment Status : Unknown
Verified June 2012 by Carol A. Tamminga, University of Texas Southwestern Medical Center.
Recruitment status was:  Recruiting
First Posted : June 29, 2011
Last Update Posted : June 22, 2012
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Carol A. Tamminga, University of Texas Southwestern Medical Center

Brief Summary:

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 or disease
Schizophrenia Schizoaffective Disorder Bipolar Disorder

Study Type : Observational
Estimated Enrollment : 1189 participants
Observational Model: Family-Based
Time Perspective: Cross-Sectional
Official Title: Neurophysiological and Genetic Studies in Schizophrenia and Other Psychiatric Disorders
Study Start Date : December 2007
Estimated Primary Completion Date : August 2012

Resource links provided by the National Library of Medicine

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Individuals with schizophrenia, schizoaffective, or bipolar I disorder.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01384604

Contact: Carol A Tamminga, MD 214-645-2789
Contact: Debra Moore Bushong, MS, LPC 214-648-4653

United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Carol A Tamminga, MD    214-645-2789   
Contact: Debra Moore Bushong, MS, LPC    214-648-4653   
Principal Investigator: Carol A Tamminga, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
National Institute of Mental Health (NIMH)

Additional Information:
Responsible Party: Carol A. Tamminga, Principal Investigator, University of Texas Southwestern Medical Center Identifier: NCT01384604     History of Changes
Other Study ID Numbers: STU 112010-097
1R01MH077851-01A2 ( U.S. NIH Grant/Contract )
First Posted: June 29, 2011    Key Record Dates
Last Update Posted: June 22, 2012
Last Verified: June 2012

Keywords provided by Carol A. Tamminga, University of Texas Southwestern Medical Center:
Schizoaffective disorder
Bipolar disorder

Additional relevant MeSH terms:
Bipolar Disorder
Psychotic Disorders
Mental Disorders
Problem Behavior
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Bipolar and Related Disorders
Behavioral Symptoms