Connectomics in Psychiatric Classification of Bipolar Disorder and Schizophrenia

Schizophrenia Clinical Trial

Official title:

Connectomics in Psychiatric Classification

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02756065
• Other study ID #: 201404123
• Status: Completed
• Start date: September 2014
• Est. completion date: August 2019

Study information

• Verified date: February 2021
• Source: Washington University Early Recognition Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Washington University Early Recognition Center is conducting a research study to examine brain functional connectivity and network patterns in participants with bipolar disorder and schizophrenia.

Description:

This study extends the assessment of brain connectivity and function, being conducted in the Human Connectome Project (HCP), to psychiatrically ill populations. The HCP consortium has made significant improvements in MRI instrumentation, data acquisition, preprocessing, and analysis. These improvements are currently providing publicly available data on the structure, function, and connectivity of young adult human (age 22-35) brains at unprecedented spatial resolution, temporal resolution, and accuracy. This study will focus on individuals aged 18-40 years who have a diagnosis of either schizophrenia/schizoaffective disorder or bipolar disorder, or are healthy controls. Additionally, similar to the HCP, the investigator will study the effect of genetics on the patterns of brain connectivity in various psychiatric populations. DNA will be collected non-invasively from saliva. Furthermore, this investigator will study cortisol levels in hair samples as an additional assessment to help characterize brain imagining findings.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Between ages 18-30

Exclusion Criteria:

• Head Injury

• Unstable Medical Condition

Related Conditions & MeSH terms

• Bipolar Disorder
• Schizophrenia

Intervention

Other:
• no intervention
no intervention is used

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University Early Recognition Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI Brain Imaging	The current project aims to uncover latent, homogenous, connectivity phenotypes using neuroimaging tools, which are free from the limitations of traditional diagnostic boundaries, and which correlate with clinical characteristics. The investigator will use resting state functional connectivity MRI (rs-fcMRI), diffusion MRI (dMRI) and tract-based spatial statistics (TBSS) to identify brain signatures that cut across schizophrenia (SZ) and bipolar (BP).	within one month of study enrollment
Secondary	DNA testing through saliva	Saliva samples will be collected from participants for DNA extraction and the development of lymphoblastoid cell lines. DNA is used for research purposes only, for studies assessing brain connectivity in schizophrenia, bipolar disorder and control subjects.	within one month of study enrollment
Secondary	Hair sample for cortisol measurement	To see how cortisol levels can help characterize brain imaging findings	within one month of study enrollment