Bipolar DisorderNCT02756065
Connectomics in Psychiatric Classification of Bipolar Disorder and Schizophrenia
An observational study of Bipolar Disorder and Schizophrenia, run by Washington University Early Recognition Center at 1 site in United States.
Trial summary
Washington University Early Recognition Center is conducting a research study to examine brain functional connectivity and network patterns in participants with bipolar disorder and schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Bipolar Disorder, Schizophrenia
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Aug 2019
- 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 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Study population: Individuals between the ages of 18-30 with a diagnosis of Bipolar Disorder or Schizophrenia
Who may be able to join
- Between ages 18-30
Who cannot join
- Head Injury
- Unstable Medical Condition
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Connectomics in Psychiatric Classification
Washington University Early Recognition Center is conducting a research study to examine brain functional connectivity and network patterns in participants with bipolar disorder and schizophrenia.
Read the detailed description
This study extends the assessment of brain connectivity and function, being conducted in the Human Connectome Project (HCP), to psychiatrically ill populations. The HCP consortium has made significant improvements in MRI instrumentation, data acquisition, preprocessing, and analysis. These improvements are currently providing publicly available data on the structure, function, and connectivity of young adult human (age 22-35) brains at unprecedented spatial resolution, temporal resolution, and accuracy. This study will focus on individuals aged 18-40 years who have a diagnosis of either schizophrenia/schizoaffective disorder or bipolar disorder, or are healthy controls. Additionally, similar to the HCP, the investigator will study the effect of genetics on the patterns of brain connectivity in various psychiatric populations. DNA will be collected non-invasively from saliva. Furthermore, this investigator will study cortisol levels in hair samples as an additional assessment to help characterize brain imagining findings.
- Conditions
- Bipolar Disorder, Schizophrenia
- Being tested
- no intervention
- Keywords
- Bipolar, schizophrenia, schizoaffective
- Medical subject headings
- Bipolar Disorder, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention is used
| Study group | Role | What they receive |
|---|---|---|
| Control | Individuals between 18-30 years old No diagnosis of Bipolar Disorder or Schizophrenia No intervention used Receives: Other: no intervention | |
| Bipolar Disorder | Individuals between 18-30 years old Diagnosis of Bipolar Disorder No intervention used Receives: Other: no intervention | |
| Schizophrenia | Individuals between 18-30 years old Diagnosis of Schizophrenia or Schizoaffective Disorder No intervention used Receives: Other: no intervention |
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 schizophrenia (SZ) and bipolar (BP).
Measured: within one month of study enrollment
Secondary outcomes (2)
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 in schizophrenia, bipolar disorder and control subjects.
Measured: within one month of study enrollment
Hair sample for cortisol measurement
To see how cortisol levels can help characterize brain imaging findings
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 posted29 Apr 2016 (estimated)
- Study startSep 2014
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- 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
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University Early Recognition Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Mamah, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756065
- Sponsor's protocol ID
- 201404123
- Status last verified
- Feb 2021
- First submitted
- 17 Jun 2015
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connectomics in Psychiatric Classification
- ClinicalTrials.gov ID
- NCT02756065
- Acronym / sponsor ID
- 201404123
- Conditions
- Bipolar Disorder, Schizophrenia
- Keywords
- Bipolar, schizophrenia, schizoaffective
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Washington University Early Recognition CenterUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 29 Apr 2016 (estimated)
- 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.
Washington University Early Recognition Center is conducting a research study to examine brain functional connectivity and network patterns in participants with bipolar disorder and schizophrenia.
Detailed description
This study extends the assessment of brain connectivity and function, being conducted in the Human Connectome Project (HCP), to psychiatrically ill populations. The HCP consortium has made significant improvements in MRI instrumentation, data acquisition, preprocessing, and analysis. These improvements are currently providing publicly available data on the structure, function, and connectivity of young adult human (age 22-35) brains at unprecedented spatial resolution, temporal resolution, and accuracy. This study will focus on individuals aged 18-40 years who have a diagnosis of either schizophrenia/schizoaffective disorder or bipolar disorder, or are healthy controls. Additionally, similar to the HCP, the investigator will study the effect of genetics on the patterns of brain connectivity in various psychiatric populations. DNA will be collected non-invasively from saliva. Furthermore, this investigator will study cortisol levels in hair samples as an additional assessment to help characterize brain imagining findings.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: no interventionIndividuals between 18-30 years old No diagnosis of Bipolar Disorder or Schizophrenia No intervention used |
| Bipolar Disorder | – | Other: no interventionIndividuals between 18-30 years old Diagnosis of Bipolar Disorder No intervention used |
| Schizophrenia | – | Other: no interventionIndividuals between 18-30 years old Diagnosis of Schizophrenia or Schizoaffective Disorder No intervention used |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Individuals between the ages of 18-30 with a diagnosis of Bipolar Disorder or Schizophrenia
Key inclusion criteria (1 listed)
- Between ages 18-30
Key exclusion criteria (2 listed)
- Head Injury
- Unstable Medical Condition
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 |
|---|---|---|
| no interventionno intervention is used | Other | Bipolar Disorder, Control, Schizophrenia |
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 schizophrenia (SZ) and bipolar (BP).
2 secondary outcomes
DNA testing through saliva
Time frame: within one month of study enrollment
Hair sample for cortisol measurement
Time frame: within one month of study enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Daniel Mamah principal investigator
Washington University School of Medicine
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 Bipolar Disorder and Schizophrenia, run by Washington University Early Recognition Center 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 8 Feb 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 8 Feb 2021.