SchizophreniaNCT04220099
Electroencephalogram (EEG) and Electroconvulsive Therapy(ECT) Response in Schizophrenia
An observational study of Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
This study is designed to find quantitative Electroencephalogram(qEEG) biomarkers to predict Electroconvulsive Therapy(ECT) Response in Schizophrenia Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Electroconvulsive therapy(ECT)
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 7 Jan 2020to 4 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: schizophrenia patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
About this study
Official title: 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
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Electroconvulsive therapy(ECT)
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroconvulsive therapy(ECT)Procedure or surgery
Patients recieve 8-sessions ECT treatments and those kinds of drugs they take since they were recruited remain unchanged during this study.
| Study group | Role | What they receive |
|---|---|---|
| schizophrenia patients needed ECT treatment | Whether patients need ECT treatment are assessed by clinicians according to American Psychiatric Association(APA) guidelines. Receives: Procedure: Electroconvulsive therapy(ECT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start7 Jan 2020
- Primary completion5 Jun 2020
- Study completion4 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Wang, Shanghai Mental Health Center
- Investigators
- Zhen Wang, Ph.D M.D, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220099
- Sponsor's protocol ID
- SMHC-SZD-001
- Status last verified
- Jul 2020
- First submitted
- 30 Dec 2019
- Last updated
- 7 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pretreatment Electroencephalogram (EEG) May Predict Electroconvulsive Therapy(ECT) Effect in Schizophrenia
- ClinicalTrials.gov ID
- NCT04220099
- Acronym / sponsor ID
- SMHC-SZD-001
- Conditions
- Schizophrenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 5 Jun 2020 (actual)
- Study completion
- 4 Jul 2020 (actual)
- First posted
- 7 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| schizophrenia patients needed ECT treatment | – | Procedure: Electroconvulsive therapy(ECT)Whether patients need ECT treatment are assessed by clinicians according to American Psychiatric Association(APA) guidelines. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- schizophrenia patients
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | schizophrenia patients needed ECT treatment |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhen Wang, Ph.D M.D principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Positive and negative syndrome scale（PANSS）score (time frame: up to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.