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

Completed

• Conditions: Schizophrenia
• Interventions: Procedure: Electroconvulsive therapy(ECT)

• Registration Number: NCT04220099
• Lead Sponsor: Shanghai Mental Health Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-12-30
• Study First Submitted QC: 2020-01-04
• Study Start: 2020-01-07
• Study First Posted: 2020-01-07
• Primary Completion: 2020-06-05
• Status Verified: 2020-07
• Study Completion: 2020-07-04
• Last Update Submitted: 2020-07-04
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
schizophrenia patients needed ECT treatment	Electroconvulsive therapy(ECT)	Whether patients need ECT treatment are assessed by clinicians according to American Psychiatric Association(APA) guidelines.

Primary Outcome Measures

Name	Time	Method
EEG functional connectivity difference between response and nonresponse group	through study completion, an average of 6 months	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.
Change in Positive and negative syndrome scale（PANSS）score	up to 4 weeks	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.

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, Shanghai, China