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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04220099
• Other study ID #: SMHC-SZD-001
• Status: Completed
• Start date: January 7, 2020
• Est. completion date: July 4, 2020

Study information

• Verified date: July 2020
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 4, 2020
• Est. primary completion date: June 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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