Brain Imaging in Early Psychosis

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

Official title:

Brain Imaging in Early Psychosis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03932188
• Other study ID #: 201904060
• Status: Enrolling by invitation
• Start date: September 1, 2020
• Est. completion date: June 19, 2021

Study information

• Verified date: November 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: June 19, 2021
• Est. primary completion date: June 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
• Personality Disorders
• Psychotic Disorders
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hair sample for cortisol measurement	To see how cortisol levels can help characterize brain imaging findings	within one month of study enrollment
Primary	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	DNA testing through saliva	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.	within one month of study enrollment