Brain Imaging in Early Psychosis

Sponsor
Washington University School of Medicine (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03932188
Collaborator
(none)
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Study Details

Study Description

Brief Summary

This study assesses brain connectivity and function of individuals ages 13-25 at a prodromal or early stage of a psychotic disorder. Participation involves approximately 3 hours of MRI scanning and up to 6 hours of behavioral testing at Washington University School of Medicine's campus.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mental Health Assessments and Computerized Cognitive Test
  • Device: MRI scan

Detailed Description

Schizophrenia is a devastating illness inflicting about 1% of the population worldwide. Symptoms of schizophrenia include paranoia, hallucinations, and disorganized behaviors, and is associated with lifelong occupational and social disability. It typically develops in adolescence or early adulthood, which are particularly formative periods in life when major educational, vocational, and social life changes occur, and then the brain undergoes a rearrangement of critical neural circuits. The "prodrome" is the period before the onset of a psychotic disorder, like schizophrenia. Prodromal youth often have significant emotional distress and social withdrawal, and family members may observe a concerning change in behavior or school or work performance. Identifying those at clinical high risk for a psychotic disorder is important, as early intervention can improve symptoms and functioning, and could prevent the eventual development of a psychotic disorder. This study will focus on individuals aged 13-25 years who have met criteria for a psychosis-risk syndrome (or attenuated psychosis syndrome) or are at a very early stage (first 3 years after diagnosis) of a psychotic disorder, such as schizophrenia or schizoaffective disorder. Involvement will be either 2 or 3 partial days at Washington University and will involve approximately 3 hours of MRI scanning and up to 6 hours of behavioral testing. Additionally, the investigators will study the effect of genetics on the patterns of brain connectivity in various psychiatric populations. DNA will be collected non-invasively from saliva and stored and processed in Washington University facilities.

Study Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Brain Imaging in Early Psychosis
Actual Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
Jun 19, 2021
Anticipated Study Completion Date :
Jun 19, 2021

Arms and Interventions

Arm Intervention/Treatment
Control

Individuals between 13-25 years old that do not meet criteria for any prodromal syndrome, any current or past psychotic disorder, or Cluster A personality disorder diagnosis

Behavioral: Mental Health Assessments and Computerized Cognitive Test
Participants will be asked to complete questionnaires and will be asked questions that address a broad range of personal life experiences involving social, occupational, domestic, and other behaviors.

Device: MRI scan
Up to two MRI scan sessions will be done, altogether totaling just under 3 hours of scanning. MR scanners measure brain anatomy and activity using very strong magnets. No X-rays or radiation are involved.

Prodromal/Early psychosis

Individuals between 13-25 years old that meet diagnostic criteria for a prodromal syndrome or early psychosis

Behavioral: Mental Health Assessments and Computerized Cognitive Test
Participants will be asked to complete questionnaires and will be asked questions that address a broad range of personal life experiences involving social, occupational, domestic, and other behaviors.

Device: MRI scan
Up to two MRI scan sessions will be done, altogether totaling just under 3 hours of scanning. MR scanners measure brain anatomy and activity using very strong magnets. No X-rays or radiation are involved.

Outcome Measures

Primary Outcome Measures

  1. 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 psychotic disorders, including schizophrenia.

Secondary Outcome Measures

  1. 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.

Other Outcome Measures

  1. Hair sample for cortisol measurement [within one month of study enrollment]

    To see how cortisol levels can help characterize brain imaging findings

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Male or female between the ages of 13 and 25

  • Meet diagnostic criteria for a prodromal syndrome or early psychosis by either meeting: 1) criteria for psychosis-risk on the structured assessment of psychosis-risk syndrome, or 2) meeting criteria for a psychotic disorder on the SCID diagnostic interview only within the last 3 years.

  • Understand and sign an informed consent (or assent form for minors) document in English

Exclusion Criteria:
  • IQ of 70 or under

  • Past or current history of clinically significant central nervous system disorder that may contribute to psychotic symptoms or confound their assessment

  • Pregnancy

  • The diagnostic symptoms are clearly caused by an Axis I disorder, including substance use disorders, as judged by the evaluating clinician.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Washington University School of Medicine Saint Louis Missouri United States 63110

Sponsors and Collaborators

  • Washington University School of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT03932188
Other Study ID Numbers:
  • 201904060
First Posted:
Apr 30, 2019
Last Update Posted:
Nov 25, 2020
Last Verified:
Nov 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Washington University School of Medicine
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 25, 2020