Bipolar I Disorder, Unspecified, With Psychotic Features Clinical Trial
— PARDIPOfficial title:
Psychosis and Affective Research Domains and Intermediate Phenotypes
Verified date | September 2019 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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.
Status | Completed |
Enrollment | 113 |
Est. completion date | December 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | UT Southwestern Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center | Beth Israel Deaconess Medical Center, Hartford Hospital, National Institute of Mental Health (NIMH), University of Georgia |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | One day | |
Primary | Differences in those with Bipolar disorder with psychosis, without psychosis, and healthy controls on functional and structural brain imaging, neurocognitive assessments, and neurophysiological tests | One day | ||
Secondary | 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. | One day |