NCT05065489

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
201

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 4, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 21, 2022

Status Verified

November 1, 2022

Enrollment Period

1.7 years

First QC Date

September 23, 2021

Last Update Submit

November 18, 2022

Conditions

SchizophreniaBipolar DisorderDepression

Keywords

electroencephalographyEating behaviorself control

Outcome Measures

Primary Outcomes (1)

  • resting state EEG

    resting state electroencephalography

    baseline

Secondary Outcomes (7)

  • Three factor eating questionnaire

    baseline

  • Barratt Impulsivity Scale

    baseline

  • Self-Control Scale

    baseline

  • The positive and negative syndrome scale

    baseline

  • Hamilton anxiety rating scale

    baseline

  • +2 more secondary outcomes

Study Arms (4)

Schizophrenia patients

patients who diagnosed with schizophrenia in accordance with DSM-5 criteria

Other: No intervention

Bipolar disorder patients

patients who diagnosed with bipolar disorder in accordance with DSM-5 criteria

Other: No intervention

Depression patients

patients who diagnosed with major depression disorder in accordance with DSM-5 criteria

Other: No intervention

Health control

health participants who have not diagnosed with any psychological or psychiatric disease.

Other: No intervention

Interventions

No interventionOTHER

No intervention

Bipolar disorder patientsDepression patientsHealth controlSchizophrenia patients

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants were recuited for single center, second xiangya hospital psychiatry department. Both inpatients and outpatients were recuited.

You may qualify if:

  • Diagnosed with schizophrenia or bipolar disorder or MDD in accordance with DMS-5 Informed Consent

You may not qualify if:

  • Diagnosed with other mental disease in accordance with DSM-5 Comorbid with other severe physiological disease Drug or alcohol abuse Pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mental Health Institute of 2nd Xiangya Hospital,CSU

Changsha, Hunan, 410011, China

Location

MeSH Terms

Conditions

SchizophreniaBipolar DisorderDepressionFeeding BehaviorSelf-Control

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood DisordersBehavioral SymptomsBehaviorBehavior, AnimalSocial Behavior

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 23, 2021

First Posted

October 4, 2021

Study Start

September 1, 2021

Primary Completion

June 1, 2023

Study Completion

December 1, 2023

Last Updated

November 21, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)