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

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

Completed

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Change in Positive and negative syndrome scale（PANSS）score

Time frame: 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.
EEG functional connectivity difference between response and nonresponse group

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Jan 7, 2020
Registry last updated: Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed