An observational study in Bipolar I Disorder, Unspecified, With Psychotic Features and Bipolar I Disorder, Unspecified, Without Psychotic Features, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-19.
Sponsored by University of Texas Southwestern Medical Center · Observational
The objective of this multi-site research collaboration is to test the manifestation and distribution of biological markers for psychosis and affect dimensions across the schizophrenia/bipolar (SZ-BD) diagnostic boundary, and to examine heritability and genetic associations for these biological markers.
The B-SNIP research consortium previously obtained dense phenotypes across the psychosis spectrum in an effort to observe features both (i) distinctive to and (ii) shared between DSM-type categorical diagnoses. Despite the broad range of extra-clinical phenotypes, we had limited success finding clinical SZ-BD diagnosis-specific features; instead, most phenotypes were distributed continuously across DSM diagnoses. To describe more biologically homogeneous groups, therefore, we combined all psychosis probands and implemented a multi-stage analysis procedure, beginning with identification of psychosis biomarkers (variables with the largest effect sizes for differentiating psychosis and healthy groups) including cognitive, electrophysiological, and oculo-motor measures ('classical' endophenotypes). We then estimated the number of subgroups that efficiently optimized variance among the biomarkers (n=3) and differentiated the individual psychosis cases into these subgroups. Subsequently, the subgroups were tested for biological uniqueness using meaningful external validators (structural and functional brain imaging, social functioning, and familial data). Given the neurobiological distinctiveness of these subgroups, we called them psychosis Biotypes. DSM diagnoses were distributed across all Biotypes. Compared to DSM diagnoses, Biotype membership enhanced group separations on biomarkers. These results indicate that groups of psychosis cases can be generated with homogeneous phenotypic characteristics independent of DSM diagnoses. The proposed study aims to further develop Biotype definitions and demonstrate that psychosis Biotypes constructed from a dense biomarker panel (i) are replicable, (ii) neurobiologically distinctive, and (iii) have unique genetic characteristics.
1,637 studies on the registry are indexed under Bipolar Disorder; 258 are open to participants now.
This study's enrollment of 113 is below the median of 158 across 339 observational studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →University of Texas Southwestern Medical Center is the lead sponsor of 1,009 studies on the registry; 201 are open to participants now.
Of its 138 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
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The study population will be comprised of individuals between the ages of 18-60 years old who meet DSM-IV criteria for Bipolar I disorder, read/speak/understand the English language, and are deemed capable of completing the study procedures by the research investigators.
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Exclusion Criteria:
Individuals diagnosed with Bipolar I disorder, with psychotic features
Individuals diagnosed with Bipolar I disorder, without psychotic features
Must have no personal history of any psychotic or mood disorder, or a family history of psychotic or recurrent mood disorder among their first-degree relatives
Differences in those with Bipolar disorder with psychosis, without psychosis, and healthy controls on functional and structural brain imaging, neurocognitive assessments, and neurophysiological tests
Time frame: One day
Differences in those with Bipolar disorder with psychosis, without psychosis, and healthy controls on clinical assessment questionnaires
The investigators will assess clustering of probands and relatives across composite biomarkers independent of diagnostic status using multivariate taxometric procedures.
Time frame: One day
Differences in those with Bipolar disorder with psychosis, without psychosis, and healthy controls in DNA and dermal biopsy sampling
The investigators will collect DNA from all proband and relative subjects and collaboratively sequence the genetic material to associate genes with specific biomarkers and composite Biotype definitions. We will also collect plasma and cellular specimens to bank for analysis of additional molecular biomarkers unique to each Biotype.
Time frame: One day
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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