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Psychosis and Affective Research Domains and Intermediate Phenotypes (PARDIP)

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ClinicalTrials.gov Identifier: NCT02218853
Recruitment Status : Recruiting
First Posted : August 18, 2014
Last Update Posted : May 16, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Bipolar I Disorder, Unspecified, With Psychotic Features Bipolar I Disorder, Unspecified, Without Psychotic Features

Detailed Description:
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.

Study Design

Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Psychosis and Affective Research Domains and Intermediate Phenotypes
Study Start Date : April 2014
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Bipolar I disorder, with psychosis
Individuals diagnosed with Bipolar I disorder, with psychotic features
Bipolar I disorder, without psychosis
Individuals diagnosed with Bipolar I disorder, without psychotic features
Healthy Controls
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Differences in those with Bipolar disorder with psychosis, without psychosis, and healthy controls on clinical assessment questionnaires [ Time Frame: One day ]
    The investigators will assess clustering of probands and relatives across composite biomarkers independent of diagnostic status using multivariate taxometric procedures.


Other Outcome Measures:
  1. Differences in those with Bipolar disorder with psychosis, without psychosis, and healthy controls in DNA and dermal biopsy sampling [ Time Frame: One day ]
    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.


Biospecimen Retention:   Samples With DNA
DNA will be extracted from blood (or buccal swab) and stored at the UT Southwestern Human Genetic Center in a departmental freezer at -80 degrees. Part of the blood sample will be used to create an immortalized lymphocyte culture (a lymphoblastoid cell line) for future genetic analysis, and will be stored in a Cell Bank at the UT Southwestern Human Genetic Center. The blood samples will be labeled by a coded identifier (number) and will not be personally identifiable. Only specifically designated research staff from Dr. Tamminga's group and from the UT Southwestern Human Genetic Center will have an access to stored DNA samples. All samples will be de-identified. The genetic data will be in password-protected computers in the Investigators' research offices.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • Must provide consent to participate after being fully informed about the study procedures and the information to be collected
  • Males and females
  • Ages 18-60 years old
  • All races and ethnicities
  • Probands: Must meet DSM-IV criteria for bipolar I disorder with or without lifetime history of psychosis; Healthy Controls: 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
  • Must be judged to be capable of completing the study procedures by study investigators
  • Must be able to read, speak, and understand English

Exclusion Criteria:

  • An estimated IQ<70
  • Major neurological or cognitive disorder (e.g., seizure disorder, traumatic brain injury, cerebrovascular disease, pervasive developmental disorder)
  • Serious medical, neuro-ophthalmological, or neurological illness that could affect CNS functioning (e.g., decompensated cardiovascular disease, decompensated chronic obstructive pulmonary disease, late stages of diabetes, AIDS)
  • DSM-IV diagnosis of alcohol or illicit substance abuse within 1 month, or alcohol or substance dependence within 3 months, or extensive history of past substance use
  • Women who are pregnant (due to unknown risks related to MRI exposure)
  • Presence of medical (e.g., artificial joints, brain aneurism clips, surgical pins, rods, wires, implants) or non-medical (e.g., metal piercing) irremovable metallic objects on/inside body (due to MRI-relevant risks)
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT02218853


Contacts
Contact: Asha Philip, M.D. 214-648-5276 asha.philip@utsouthwestern.edu
Contact: Morteza Rastegari, B.A. 214-648-5283 morteza.rastegari@utsouthwestern.edu

Locations
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Sub-Investigator: Elena Ivleva, M.D., Ph.D.         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Beth Israel Deaconess Medical Center
Hartford Hospital
University of Georgia
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Carol A Tamminga, M.D. UT Southwestern Medical Center
More Information

Additional Information:
Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02218853     History of Changes
Other Study ID Numbers: MH077851
1R01MH096913-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: May 16, 2016
Last Verified: May 2016

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

Additional relevant MeSH terms:
Disease
Psychotic Disorders
Mental Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders