Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)NCT03932188
Brain Imaging in Early Psychosis
An observational study of Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), run by Washington University School of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
- What is being tested?
- Mental Health Assessments and Computerized Cognitive Test and MRI scan
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 19 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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.
Read the 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.
- Being tested
- Mental Health Assessments and Computerized Cognitive Test, MRI scan
- Keywords
- early psychosis, prodrome, schizophrenia, psychosis
- Medical subject headings
- Depression, Psychotic Disorders, Personality Disorders, Substance-Related Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Health Assessments and Computerized Cognitive TestBehavioural
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.
MRI scanDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Mental Health Assessments and Computerized Cognitive Test; Device: MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within one month of study enrollment
Secondary outcomes (1)
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.
Measured: within one month of study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start1 Sep 2020
- Primary completion19 Jun 2021 (estimated)
- Study completion19 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)Studies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932188
- Sponsor's protocol ID
- 201904060
- Status last verified
- Nov 2020
- First submitted
- 26 Apr 2019
- Last updated
- 25 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Imaging in Early Psychosis
- ClinicalTrials.gov ID
- NCT03932188
- Acronym / sponsor ID
- 201904060
- Keywords
- early psychosis, prodrome, schizophrenia, psychosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 19 Jun 2021 (estimated)
- Study completion
- 19 Jun 2021 (estimated)
- First posted
- 30 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Behavioral: Mental Health Assessments and Computerized Cognitive Test, Device: MRI scanIndividuals 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 | – | Behavioral: Mental Health Assessments and Computerized Cognitive Test, Device: MRI scanIndividuals between 13-25 years old that meet diagnostic criteria for a prodromal syndrome or early psychosis |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mental Health Assessments and Computerized Cognitive TestParticipants 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. | Behavioural | Control, Prodromal/Early psychosis |
| MRI scanUp 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. | Device | Control, Prodromal/Early psychosis |
Primary outcome
MRI Brain Imaging
Time frame: 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.
1 secondary outcome
DNA testing through saliva
Time frame: within one month of study enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
Related trials for Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
Recruiting
Preventing Vulnerable Child Syndrome in the NICU With Cognitive Behavioral Therapy (PreVNT Trial)
Premature Infant, Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI Brain Imaging (time frame: within one month of study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2020.