Resting State Electroencephalogram for Psychotic Disorders

• Sponsor: Central South University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05065489
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Anticipated Duration (Months): 15
• Patients Per Site Per Month: 13.3

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia; Bipolar Disorder; Depression	Other: No intervention

Study Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Self-control, Appetite and Psychotic Diagnose: a Resting State EEG Cross Section Study
• Actual Study Start Date: Sep 1, 2021
• Anticipated Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Schizophrenia patients patients who diagnosed with schizophrenia in accordance with DSM-5 criteria	Other: No intervention; No intervention
Bipolar disorder patients patients who diagnosed with bipolar disorder in accordance with DSM-5 criteria	Other: No intervention; No intervention
Depression patients patients who diagnosed with major depression disorder in accordance with DSM-5 criteria	Other: No intervention; No intervention
Health control health participants who have not diagnosed with any psychological or psychiatric disease.	Other: No intervention; No intervention

Outcome Measures

Primary Outcome Measures

1. resting state EEG [baseline]

   resting state electroencephalography

Secondary Outcome Measures

1. Three factor eating questionnaire [baseline]

   min value 21, max value 84. The higher scores mean more unhealthy eating behavior.

2. Barratt Impulsivity Scale [baseline]

   min score 26, max score 104. The higher score means more impulsive.

3. Self-Control Scale [baseline]

   min score 36, max score 180. The higher score means less self control.

4. The positive and negative syndrome scale [baseline]

   min score 30, max score 210. The higher score means more severe symptoms.

5. Hamilton anxiety rating scale [baseline]

   min score 14, max score 56. The higher score means more severe anxiety symptom

6. Hamilton depression rating scale [baseline]

   min score 17, max score 68. The higher score means more severe depressive symptom

7. Young manic rating scale [baseline]

   min score 0, max score 60, the higher score means more severe manic syndrome.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mental Health Institute of 2nd Xiangya Hospital,CSU	Changsha	Hunan	China	410011

Sponsors and Collaborators

• Central South University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Renrong Wu,PhD, Professor, Central South University
• ClinicalTrials.gov Identifier: NCT05065489
• Other Study ID Numbers: WU2021EEG
• First Posted: Oct 4, 2021
• Last Update Posted: Oct 13, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Renrong Wu,PhD, Professor, Central South University: electroencephalography; Eating behavior; self control
• Additional relevant MeSH terms: Schizophrenia; Bipolar Disorder

Study Results

No Results Posted as of Oct 13, 2021