SchizophreniaNCT05065489
Resting State Electroencephalogram for Psychotic Disorders
An observational study of Schizophrenia and Bipolar Disorder, run by Central South University at 1 site in China.
Trial summary
Electroencephalography (EEG) has been proposed as a neurophysiological biomarker to delineate psychotic disorders. Meanwhile, the increased appetite, which might related to self-control process, has been an increasing concern for the management of psychotic disorders. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Bipolar Disorder, Depression
- How many people
- 201 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 1 Dec 2023
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants were recuited for single center, second xiangya hospital psychiatry department. Both inpatients and outpatients were recuited.
Who may be able to join
- Diagnosed with schizophrenia or bipolar disorder or MDD in accordance with DMS-5 Informed Consent
Who cannot join
- Diagnosed with other mental disease in accordance with DSM-5 Comorbid with other severe physiological disease Drug or alcohol abuse Pregnant or lactating
Trial locations and contacts
1 site in 1 country.
China1 site
Mental Health Institute of 2nd Xiangya Hospital,CSU
Changsha, Hunan, 410011
About this study
Official title: Self-control, Appetite and Psychotic Diagnose: a Resting State EEG Cross Section Study
Electroencephalography (EEG) has been proposed as a neurophysiological biomarker to delineate psychotic disorders. Meanwhile, the increased appetite, which might related to self-control process, has been an increasing concern for the management of psychotic disorders. In this cross-section study, investigators collect the resting state EEG data, self-control related scale, eating behaviour questionnaire and psychotic syndrome related assessement and try to find the connection between those measurers, in order to provide novel understanding on the mechanism of psychotic diseases.
- Conditions
- Schizophrenia, Bipolar Disorder, Depression
- Being tested
- No intervention
- Keywords
- electroencephalography, Eating behavior, self control
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Depression, Feeding Behavior, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenia patients | patients who diagnosed with schizophrenia in accordance with DSM-5 criteria Receives: Other: No intervention | |
| Bipolar disorder patients | patients who diagnosed with bipolar disorder in accordance with DSM-5 criteria Receives: Other: No intervention | |
| Depression patients | patients who diagnosed with major depression disorder in accordance with DSM-5 criteria Receives: Other: No intervention | |
| Health control | health participants who have not diagnosed with any psychological or psychiatric disease. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
resting state EEG
resting state electroencephalography
Measured: baseline
Secondary outcomes (7)
Three factor eating questionnaire
min value 21, max value 84. The higher scores mean more unhealthy eating behavior.
Measured: baseline
Barratt Impulsivity Scale
min score 26, max score 104. The higher score means more impulsive.
Measured: baseline
Self-Control Scale
min score 36, max score 180. The higher score means less self control.
Measured: baseline
The positive and negative syndrome scale
min score 30, max score 210. The higher score means more severe symptoms.
Measured: baseline
Hamilton anxiety rating scale
min score 14, max score 56. The higher score means more severe anxiety symptom
Measured: baseline
Hamilton depression rating scale
min score 17, max score 68. The higher score means more severe depressive symptom
Measured: baseline
Young manic rating scale
min score 0, max score 60, the higher score means more severe manic syndrome.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start1 Sep 2021
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
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.
- 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
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renrong Wu, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065489
- Sponsor's protocol ID
- WU2021EEG
- Status last verified
- Nov 2022
- First submitted
- 23 Sep 2021
- Last updated
- 21 Nov 2022
- 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 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-control, Appetite and Psychotic Diagnose: a Resting State EEG Cross Section Study
- ClinicalTrials.gov ID
- NCT05065489
- Acronym / sponsor ID
- WU2021EEG
- Conditions
- Schizophrenia, Bipolar Disorder, Depression
- Keywords
- electroencephalography, Eating behavior, self control
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 4 Oct 2021 (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.
Electroencephalography (EEG) has been proposed as a neurophysiological biomarker to delineate psychotic disorders. Meanwhile, the increased appetite, which might related to self-control process, has been an increasing concern for the management of psychotic disorders. In this cross-section study, investigators collect the resting state EEG data, self-control related scale, eating behaviour questionnaire and psychotic syndrome related assessement and try to find the connection between those measurers, in order to provide novel understanding on the mechanism of psychotic diseases.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia patients | – | Other: No interventionpatients who diagnosed with schizophrenia in accordance with DSM-5 criteria |
| Bipolar disorder patients | – | Other: No interventionpatients who diagnosed with bipolar disorder in accordance with DSM-5 criteria |
| Depression patients | – | Other: No interventionpatients who diagnosed with major depression disorder in accordance with DSM-5 criteria |
| Health control | – | Other: No interventionhealth participants who have not diagnosed with any psychological or psychiatric disease. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants were recuited for single center, second xiangya hospital psychiatry department. Both inpatients and outpatients were recuited.
Key inclusion criteria (1 listed)
- Diagnosed with schizophrenia or bipolar disorder or MDD in accordance with DMS-5 Informed Consent
Key exclusion criteria (1 listed)
- Diagnosed with other mental disease in accordance with DSM-5 Comorbid with other severe physiological disease Drug or alcohol abuse Pregnant or lactating
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 | Other | Bipolar disorder patients, Depression patients, Health control, Schizophrenia patients |
Primary outcome
resting state EEG
Time frame: baseline
resting state electroencephalography
7 secondary outcomes
Three factor eating questionnaire
Time frame: baseline
Barratt Impulsivity Scale
Time frame: baseline
Self-Control Scale
Time frame: baseline
The positive and negative syndrome scale
Time frame: baseline
Hamilton anxiety rating scale
Time frame: baseline
Hamilton depression rating scale
Time frame: baseline
Young manic rating scale
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- 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.
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 Schizophrenia and Bipolar Disorder, run by Central South University at 1 site in China.
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 1 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 21 Nov 2022. 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 China. 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?
resting state EEG (time frame: baseline). 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 21 Nov 2022.