SchizophreniaNCT01425671
Neural Oscillations as Genetic and Functional Biomarkers in Normal and Disease States
An observational study of Schizophrenia and Schizoaffective Disorder, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The principle aim of the project is to analyze brain electrical activity and genetic information that will help identify the nature and cause of the disease schizophrenia. This effort should lay the groundwork for future treatment in schizophrenic patients. Read more about this study
- Who is it for?
- Ages 14 to 62 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2010to Jan 2024
- 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 14 to 62 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Schizophrenic patients, family members, controls
Who may be able to join
- Male and Female between ages 14-62 (clinical assessment and blood draw only above 62)
- Ability to give written assent (subjects who are below the age of 18)
- Ability to give written informed consent (age 18 or above)
- Sufficient understanding of the study and risks (ESC score 10 or above)
- Subjects above age 62 will not participate in brain electrical activity measurements although they may still participate in clinical assessments and blood draw.
Who cannot join
- Inability to sign informed consent/assent
- Any major medical illness that may affect normal brain functioning. Examples of these conditions include, but not limited to, stroke, repeated seizure, history of significant head trauma, CNS infection or tumor, an other significant brain neurological conditions.
- Significant alcohol or drug use (substance dependence within 6 months or substance abuse within 1 month) other than nicotine or marijuana dependence.
- Woman who is pregnant (child bearing potential but not on contraceptive and missing menstrual period; or by self-report; or by positive pregnancy test).
- Can not refrain from using alcohol and/or marijuana 24 hours or more\& cigarette smoking half and hour or more prior to experiments.
Trial locations and contacts
1 site in 1 country.
United States1 site
Maryland Psychiatric Research Center
Baltimore, Maryland, 21228
About this study
The principle aim of the project is to analyze brain electrical activity and genetic information that will help identify the nature and cause of the disease schizophrenia. This effort should lay the groundwork for future treatment in schizophrenic patients.
Read the detailed description
There are several studies and hypotheses to be tested. This project includes a cross-sectional study design measuring brain waves, clinical symptoms, cognitive and functional ability, and genetic information in schizophrenic patients and normal controls. Subjects are expected to do a brain wave recording (EEG/ERP), role-play test designed to measure functionality and cognitive ability, and clinical symptom assessments. Expected duration of subject participation will be approximately 8 hours (about 2 visits). Outcome measures includes biomarkers, clinical symptoms and function, and genetic information.
- Keywords
- Schizophrenia, Family, Psychosis
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenic patients, family members | Schizophrenia Spectrum Disorder Patients | |
| Controls | Normal controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
We will measure oscillatory abnormalities in resting, sensory response to single sound (SS), response to steady state auditory evoked potential , to a continuous matching task , and response during encoding and retrieval during a sensory retention task.
Measured: 10-12 hours
Secondary outcomes (1)
Symptom and Cognition rating
Measured: 2 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2011 (estimated)
- Study start30 Nov 2010
- Primary completionAug 2023
- Study completionJan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Cross-sectional
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, L. Elliot Hong, University of Maryland, Baltimore
- Investigators
- L.Elliot Hong, M.D., Principal investigator, Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425671
- Sponsor's protocol ID
- HP-00043082
- Other IDs
- R01MH085646
- Status last verified
- Nov 2023
- First submitted
- 28 Aug 2011
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Oscillations as Genetic and Functional Biomarkers in Normal and Disease States
- ClinicalTrials.gov ID
- NCT01425671
- Acronym / sponsor ID
- HP-00043082
- Keywords
- Schizophrenia, Family, Psychosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 30 Nov 2010 (actual)
- Primary completion
- Aug 2023 (actual)
- Study completion
- Jan 2024 (actual)
- First posted
- 30 Aug 2011 (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.
The principle aim of the project is to analyze brain electrical activity and genetic information that will help identify the nature and cause of the disease schizophrenia. This effort should lay the groundwork for future treatment in schizophrenic patients.
Detailed description
There are several studies and hypotheses to be tested. This project includes a cross-sectional study design measuring brain waves, clinical symptoms, cognitive and functional ability, and genetic information in schizophrenic patients and normal controls. Subjects are expected to do a brain wave recording (EEG/ERP), role-play test designed to measure functionality and cognitive ability, and clinical symptom assessments. Expected duration of subject participation will be approximately 8 hours (about 2 visits). Outcome measures includes biomarkers, clinical symptoms and function, and genetic information.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Schizophrenic patients, family members | – | –Schizophrenia Spectrum Disorder Patients |
| Controls | – | –Normal controls |
Who may qualify
- Ages
- 14 to 62 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Schizophrenic patients, family members, controls
Key inclusion criteria (5 listed)
- Male and Female between ages 14-62 (clinical assessment and blood draw only above 62)
- Ability to give written assent (subjects who are below the age of 18)
- Ability to give written informed consent (age 18 or above)
- Sufficient understanding of the study and risks (ESC score 10 or above)
- Subjects above age 62 will not participate in brain electrical activity measurements although they may still participate in clinical assessments and blood draw.
Key exclusion criteria (5 listed)
- Inability to sign informed consent/assent
- Any major medical illness that may affect normal brain functioning. Examples of these conditions include, but not limited to, stroke, repeated seizure, history of significant head trauma, CNS infection or tumor, an other significant brain neurological conditions.
- Significant alcohol or drug use (substance dependence within 6 months or substance abuse within 1 month) other than nicotine or marijuana dependence.
- Woman who is pregnant (child bearing potential but not on contraceptive and missing menstrual period; or by self-report; or by positive pregnancy test).
- Can not refrain from using alcohol and/or marijuana 24 hours or more\& cigarette smoking half and hour or more prior to experiments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
We will measure oscillatory abnormalities in resting, sensory response to single sound (SS), response to steady state auditory evoked potential , to a continuous matching task , and response during encoding and retrieval during a sensory retention task.
Time frame: 10-12 hours
1 secondary outcome
Symptom and Cognition rating
Time frame: 2 hrs
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 26 Apr 2024.
- 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.
L.Elliot Hong, M.D. principal investigator
Maryland Psychiatric Research Center, Department of Psychiatry, University of Maryland 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 Schizophrenia and Schizoaffective Disorder, run by University of Maryland, Baltimore 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 5 inclusion and 5 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 26 Apr 2024. 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?
We will measure oscillatory abnormalities in resting, sensory response to single sound (SS), response to steady state auditory evoked potential , to a continuous matching task , and response during encoding and retrieval during a sensory retention task. (time frame: 10-12 hours). 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 26 Apr 2024.