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Completed

NCT Number: NCT02756065

Connectomics in Psychiatric Classification of Bipolar Disorder and Schizophrenia

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between ages 18-30

Exclusion criteria

  • Head Injury
  • Unstable Medical Condition

Treatment and study plan

No intervention

Other

no intervention is used

Primary outcomes

  1. MRI Brain Imaging

    Time frame: 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 outcomes

  1. DNA testing through saliva

    Time frame: 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.

  2. Hair sample for cortisol measurement

    Time frame: within one month of study enrollment

    To see how cortisol levels can help characterize brain imaging findings

Sponsors and collaborators

Lead sponsor

Washington University Early Recognition Center

Other

Registry information

Official study title

Connectomics in Psychiatric Classification

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Apr 29, 2016
Registry last updated
Feb 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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