Brain Imaging in Early Psychosis

• Conditions: Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
• Interventions: Behavioral: Mental Health Assessments and Computerized Cognitive Test; Device: MRI scan

• Registration Number: NCT03932188
• Lead Sponsor: Washington University School of Medicine

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.

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 Timeline

• Study First Submitted: 2019-04-26
• Study First Submitted QC: 2019-04-26
• Study First Posted: 2019-04-30
• Study Start: 2020-09-01
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-24
• Last Update Posted: 2020-11-25
• Primary Completion: 2021-06-19
• Study Completion: 2021-06-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Mental Health Assessments and Computerized Cognitive Test	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
Prodromal/Early psychosis	MRI scan	Individuals between 13-25 years old that meet diagnostic criteria for a prodromal syndrome or early psychosis
Prodromal/Early psychosis	Mental Health Assessments and Computerized Cognitive Test	Individuals between 13-25 years old that meet diagnostic criteria for a prodromal syndrome or early psychosis
Control	MRI scan	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

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 psychotic disorders, including schizophrenia.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

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