Brain Imaging in Early Psychosis

NCT03932188 | Unknown

• 1 other identifier: 201904060
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)

Keywords

early psychosis; prodrome; schizophrenia; psychosis

Outcome Measures

Primary Outcomes (1)

• 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 psychotic disorders, including schizophrenia.

  within one month of study enrollment

Secondary Outcomes (1)

• DNA testing through saliva

  within one month of study enrollment

Other Outcomes (1)

• Hair sample for cortisol measurement

  within one month of study enrollment

Study Arms (2)

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; Device: MRI scan

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; Device: MRI scan

Interventions

Mental Health Assessments and Computerized Cognitive Test BEHAVIORAL

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.

Control; Prodromal/Early psychosis

MRI scan DEVICE

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.

Control; Prodromal/Early psychosis

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Individuals aged 13-25 years who have met criteria for a psychosis-risk syndrome or at a very early stage of a psychotic disorder, such as schizophrenia or schizoaffective disorder.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Depression; Psychotic Disorders; Personality Disorders; Substance-Related Disorders; Schizophrenia

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: April 30, 2019
• Study Start: September 1, 2020
• Primary Completion: June 19, 2021
• Study Completion: June 19, 2021
• Last Updated: November 25, 2020

Record last verified: 2020-11

Locations

US (1)