Electroencephalogram (EEG) and Electroconvulsive Therapy(ECT) Response in Schizophrenia

Pretreatment Electroencephalogram (EEG) May Predict Electroconvulsive Therapy(ECT) Effect in Schizophrenia

This study is designed to find quantitative Electroencephalogram(qEEG) biomarkers to predict Electroconvulsive Therapy(ECT) Response in Schizophrenia

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Procedure: Electroconvulsive therapy(ECT)

Detailed Description

The purpose of this proposal is to explore quantitative Electroencephalogram(qEEG) biomarkers that would predict Electroconvulsive Therapy(ECT) Response in Schizophrenia (SZD). The investigators will recruit 30 SZD patients who are preparing for ECT treatment and assesse psychotic symptoms using Positive and Negative symptom scale(PANSS) before and after 8-sessions clinical course of ECT treatment. These patients needed ECT treatment are assessed by clinicians according to American Psychiatric Association(APA) guidelines. Meanwhile resting EEG will be recorded for 10 minutes before the first episode of ECT treatment. Decrease of PANSS scores will be calculated after the last session of ECT treatment to distinguish responder/non-responder.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Shanghai Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

schizophrenia patients

Description

Inclusion Criteria:

• DSM-5 criteria for SZD
• patients needed ECT treatment assessed by clinicians using American psychological Association(APA) guidelines.
• symptoms must be of at least moderate severity (PANSS score >71)
• age between 18 to 60 years old
• medications will be stable for at least four weeks prior to ECT, and there will be no dose changes unless medically necessary

Exclusion Criteria:

• any additional current psychiatric comorbidity
• pregnancy or prepare to have a baby
• current use of any Antiepileptic drugs
• history of taking any kinds of Physicotherapeutics within 6 months
• severe psychotic symptoms that make patients could not accomplish the clinical interview

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
schizophrenia patients needed ECT treatment; Whether patients need ECT treatment are assessed by clinicians according to American Psychiatric Association(APA) guidelines.	Procedure: Electroconvulsive therapy(ECT); Patients recieve 8-sessions ECT treatments and those kinds of drugs they take since they were recruited remain unchanged during this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Positive and negative syndrome scale（PANSS）score	It assessed the severity of psychotic symptoms.The responder on PANSS is defined as a PANSS decrease at least 25% from the baseline at post-treatment. PANSS helps us divide cases into response and nonresponse group.	up to 4 weeks
EEG functional connectivity difference between response and nonresponse group	This is a predictive indicator collected before ECT treatment. After treatment, we divided 30 patients into response and nonresponse group using PANSS. Then we explore differences in pretreatment EEG functional connectivity at different frequency bands (Alpha, Beta, Delta, and Theta) to find a predictable biomarker for ECT treatment effect.	through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Investigators: Principal Investigator: Zhen Wang, Ph.D M.D, Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 7, 2020
• Primary Completion (ACTUAL): June 5, 2020
• Study Completion (ACTUAL): July 4, 2020

Study Registration Dates

• First Submitted: December 30, 2019
• First Submitted That Met QC Criteria: January 4, 2020
• First Posted (ACTUAL): January 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 4, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: SMHC-SZD-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No