Connectomics in Psychiatric Classification of Bipolar Disorder and Schizophrenia

Completed

• Conditions: Schizophrenia; Bipolar Disorder
• Interventions: Other: no intervention

• Registration Number: NCT02756065
• Lead Sponsor: Washington University Early Recognition Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-06-17
• Study First Submitted QC: 2016-04-26
• Study First Posted: 2016-04-29
• Primary Completion: 2019-08
• Study Completion: 2019-08
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-03
• Last Update Posted: 2021-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• Between ages 18-30

Exclusion Criteria

• Head Injury
• Unstable Medical Condition

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bipolar Disorder	no intervention	Individuals between 18-30 years old Diagnosis of Bipolar Disorder No intervention used
Schizophrenia	no intervention	Individuals between 18-30 years old Diagnosis of Schizophrenia or Schizoaffective Disorder No intervention used
Control	no intervention	Individuals between 18-30 years old No diagnosis of Bipolar Disorder or Schizophrenia No intervention used

Primary Outcome Measures

Name	Time	Method
MRI Brain Imaging	within one month of study enrollment	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).

Secondary Outcome Measures

Name	Time	Method
Hair sample for cortisol measurement	within one month of study enrollment	To see how cortisol levels can help characterize brain imaging findings
DNA testing through saliva	within one month of study enrollment	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.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States