Clinical trial NCT03932188: Brain Imaging in Early Psychosis
Official title: Brain Imaging in Early Psychosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
Keywords: early psychosis
prodrome
schizophrenia
psychosis
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2019-04-30
Enrollment: 20
Sex: ALL
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: MRI Brain Imaging
timeFrame: within one month of study enrollment
Secondary outcomes:
measure: DNA testing through saliva
timeFrame: within one month of study enrollment
Other outcomes:
measure: Hair sample for cortisol measurement
timeFrame: within one month of study enrollment
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
References: