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

NCT04220099 | Completed

• 1 other identifier: SMHC-SZD-001
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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)

Interventions

Electroconvulsive therapy(ECT) PROCEDURE

Patients recieve 8-sessions ECT treatments and those kinds of drugs they take since they were recruited remain unchanged during this study.

schizophrenia patients needed ECT treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

schizophrenia patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Electroconvulsive Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Zhen Wang, Ph.D M.D

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice-president

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 7, 2020
• Study Start: January 7, 2020
• Primary Completion: June 5, 2020
• Study Completion: July 4, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

CN (1)