- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05065489
Resting State Electroencephalogram for Psychotic Disorders
November 18, 2022 updated by: Renrong Wu, Central South University
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
201
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410011
- Mental Health Institute of 2nd Xiangya Hospital,CSU
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants were recuited for single center, second xiangya hospital psychiatry department.
Both inpatients and outpatients were recuited.
Description
Inclusion Criteria:
Diagnosed with schizophrenia or bipolar disorder or MDD in accordance with DMS-5 Informed Consent
Exclusion Criteria:
Diagnosed with other mental disease in accordance with DSM-5 Comorbid with other severe physiological disease Drug or alcohol abuse Pregnant or lactating
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Schizophrenia patients
patients who diagnosed with schizophrenia in accordance with DSM-5 criteria
|
No intervention
|
|
Bipolar disorder patients
patients who diagnosed with bipolar disorder in accordance with DSM-5 criteria
|
No intervention
|
|
Depression patients
patients who diagnosed with major depression disorder in accordance with DSM-5 criteria
|
No intervention
|
|
Health control
health participants who have not diagnosed with any psychological or psychiatric disease.
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
resting state EEG
Time Frame: baseline
|
resting state electroencephalography
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Three factor eating questionnaire
Time Frame: baseline
|
min value 21, max value 84.
The higher scores mean more unhealthy eating behavior.
|
baseline
|
|
Barratt Impulsivity Scale
Time Frame: baseline
|
min score 26, max score 104.
The higher score means more impulsive.
|
baseline
|
|
Self-Control Scale
Time Frame: baseline
|
min score 36, max score 180.
The higher score means less self control.
|
baseline
|
|
The positive and negative syndrome scale
Time Frame: baseline
|
min score 30, max score 210.
The higher score means more severe symptoms.
|
baseline
|
|
Hamilton anxiety rating scale
Time Frame: baseline
|
min score 14, max score 56.
The higher score means more severe anxiety symptom
|
baseline
|
|
Hamilton depression rating scale
Time Frame: baseline
|
min score 17, max score 68.
The higher score means more severe depressive symptom
|
baseline
|
|
Young manic rating scale
Time Frame: baseline
|
min score 0, max score 60, the higher score means more severe manic syndrome.
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 1, 2021
Primary Completion (ANTICIPATED)
June 1, 2023
Study Completion (ANTICIPATED)
December 1, 2023
Study Registration Dates
First Submitted
September 23, 2021
First Submitted That Met QC Criteria
September 23, 2021
First Posted (ACTUAL)
October 4, 2021
Study Record Updates
Last Update Posted (ACTUAL)
November 21, 2022
Last Update Submitted That Met QC Criteria
November 18, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WU2021EEG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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