Schizophrenia, Bipolar DisorderNCT03651674
Longitudinal Effect of Electroconvulsive Therapy on Schizophrenia and Bipolar Disorder: a MRI Study
A study testing ECT treatment and Drug treatment in people with Schizophrenia, Bipolar Disorder, run by Xidian University.
Trial summary
For more severe and treatment-resistant cases in schizophrenia and bipolar disorder, electroconvulsive therapy (ECT) is often very effective. The purpose of this study is to investigate the brain structure and function changes after ECT treatment. Read more about this study
- Who is it for?
- Ages 15 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Bipolar Disorder
- What is being tested?
- ECT treatment and Drug treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2018to 1 Apr 2020
- Phase
- Interventional
- 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 15 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- International classification of diseases (ICD) diagnosis of Schizophrenia and bipolar disorder;
- Ages 15-70
- All participants are ethnic Han
- Not received ECT treatment before
- PANSS ≥ 60 for schizophrenia subjects
- The patient's written informed consent can be obtained. If the patient is incapacitated during the onset period, the written informed consent of the legal guardian is required.
Who cannot join
- Those with mental retardation, generalized developmental disorders,delirium, dementia, memory impairment or cognitive impairment that meet the diagnostic criteria of ICD-10;
- Patients with cognitive impairment, such as Parkinson's, multiple sclerosis, stroke, and patients who meet the diagnostic criteria for ICD-10 alcohol dependence (except nicotine dependence);
- The course of the disease is very short (fast phase inversion), such as 4 or more different mood abnormalities (depression, mild mania, mania, mental illness) in one year;
- With severe unstable physical diseases; diagnosed diabetes, thyroid disease, hypertension, heart disease, etc.;
- Narrow angle glaucoma;
- With a history of epilepsy, except those with febrile seizures;
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- Have or have had drug-induced malignant syndrome and severe tardive dyskinesia;
- With serious suicide attempts;
- Cannot take medication as directed by their doctors, or who do not have guardians;
- Pregnant or lactating women, or those who plan to become pregnant;
Trial locations and contacts
No sites are listed yet.
About this study
For more severe and treatment-resistant cases in schizophrenia and bipolar disorder, electroconvulsive therapy (ECT) is often very effective. The purpose of this study is to investigate the brain structure and function changes after ECT treatment. The neuroimaging marker which may predict the outcome of ECT is also studied in this research.
- Conditions
- Schizophrenia, Bipolar Disorder
- Being tested
- ECT treatment, Drug treatment
- Medical subject headings
- Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECT treatmentDevice
Patients had bilateral temporal modified ECT four times a week for 3 consecutive weeks
Drug treatmentDrug
Also called olanzapine,clozapine,magnesium valproat,etc.
Patients only have antipsychotic drugs
| Study group | Role | What they receive |
|---|---|---|
| ECT treatment | Active comparator | Patients received bilateral temporal modified ECT (MECT) for three weeks,four times a week. Meanwhile, they also had antipsychotic drugs. Receives: Device: ECT treatment |
| Drug treatment | Sham comparator | Patients only received antipsychotic drugs during observation period. Receives: Drug: Drug treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Positive And Negative Syndrome Scale(PANSS)for Schizophrenia;
Scales changes from baseline will be documented after three weeks treatment and 3 months follow-up visit.
Measured: 3 time points: baseline, the end of the three-week treatment，3 months after ECT or drugs treatment
Change of Bech-Rafaelsen Mania Rating Scale (BRMS) for Bipolar disorder
Scales changes from baseline will be documented after three weeks treatment and 3 months follow-up visit.
Measured: 3 time points: baseline, the end of the three-week treatment，3 months after ECT or drugs treatment
Change of Hamilton Anxiety Scale (HAMA) for Bipolar disorder
Scales changes from baseline will be documented after three weeks treatment and 3 months follow-up visit.
Measured: 3 time points: baseline, the end of the three-week treatment，3 months after ECT or drugs treatment
Change of Hamilton depression scale (HAMD) for Bipolar disorder
Scales changes from baseline will be documented after three weeks treatment and 3 months follow-up visit.
Measured: 3 time points: baseline, the end of the three-week treatment，3 months after ECT or drugs treatment
Secondary outcomes (2)
Changes of brain gray matter, white matter and functional based on MRI data analysis
The changes of gray matter volume,structural integrity of white matter,and brain function during resting state after treatment will be analyzed.
Measured: 2 time points:baseline, the end of the three-week treatment]
Change of Mini-Mental State Examination
Scale change from baseline will be documented after three weeks treatment and 3 months follow-up visit.
Measured: 3 time points: baseline, the end of the three-week treatment，3 months after ECT or drugs treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start20 Sep 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion1 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia, Bipolar DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xidian University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651674
- Sponsor's protocol ID
- 81471815
- Status last verified
- Aug 2018
- First submitted
- 23 Aug 2018
- Last updated
- 29 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Effect of Electroconvulsive Therapy on Schizophrenia and Bipolar Disorder: a MRI Study
- ClinicalTrials.gov ID
- NCT03651674
- Acronym / sponsor ID
- 81471815
- Conditions
- Schizophrenia, Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xidian UniversityUniversity, hospital or other
- Study start
- 20 Sep 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 1 Apr 2020 (estimated)
- First posted
- 29 Aug 2018 (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.
For more severe and treatment-resistant cases in schizophrenia and bipolar disorder, electroconvulsive therapy (ECT) is often very effective. The purpose of this study is to investigate the brain structure and function changes after ECT treatment. The neuroimaging marker which may predict the outcome of ECT is also studied in this research.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECT treatment | Active comparator | Device: ECT treatmentPatients received bilateral temporal modified ECT (MECT) for three weeks,four times a week. Meanwhile, they also had antipsychotic drugs. |
| Drug treatment | Sham comparator | Drug: Drug treatmentPatients only received antipsychotic drugs during observation period. |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- International classification of diseases (ICD) diagnosis of Schizophrenia and bipolar disorder;
- Ages 15-70
- All participants are ethnic Han
- Not received ECT treatment before
- PANSS ≥ 60 for schizophrenia subjects
Key exclusion criteria (10 listed)
- Those with mental retardation, generalized developmental disorders,delirium, dementia, memory impairment or cognitive impairment that meet the diagnostic criteria of ICD-10;
- Patients with cognitive impairment, such as Parkinson's, multiple sclerosis, stroke, and patients who meet the diagnostic criteria for ICD-10 alcohol dependence (except nicotine dependence);
- The course of the disease is very short (fast phase inversion), such as 4 or more different mood abnormalities (depression, mild mania, mania, mental illness) in one year;
- With severe unstable physical diseases; diagnosed diabetes, thyroid disease, hypertension, heart disease, etc.;
- Narrow angle glaucoma;
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 |
|---|---|---|
| ECT treatmentPatients had bilateral temporal modified ECT four times a week for 3 consecutive weeks | Device | ECT treatment |
| Drug treatmentAlso: olanzapine,clozapine,magnesium valproat,etc.Patients only have antipsychotic drugs | Drug | Drug treatment |
Primary outcome
Changes of Positive And Negative Syndrome Scale(PANSS)for Schizophrenia;
Time frame: 3 time points: baseline, the end of the three-week treatment，3 months after ECT or drugs treatment
Scales changes from baseline will be documented after three weeks treatment and 3 months follow-up visit.
Change of Bech-Rafaelsen Mania Rating Scale (BRMS) for Bipolar disorder
Time frame: 3 time points: baseline, the end of the three-week treatment，3 months after ECT or drugs treatment
Scales changes from baseline will be documented after three weeks treatment and 3 months follow-up visit.
Change of Hamilton Anxiety Scale (HAMA) for Bipolar disorder
Time frame: 3 time points: baseline, the end of the three-week treatment，3 months after ECT or drugs treatment
Scales changes from baseline will be documented after three weeks treatment and 3 months follow-up visit.
Change of Hamilton depression scale (HAMD) for Bipolar disorder
Time frame: 3 time points: baseline, the end of the three-week treatment，3 months after ECT or drugs treatment
Scales changes from baseline will be documented after three weeks treatment and 3 months follow-up visit.
2 secondary outcomes
Changes of brain gray matter, white matter and functional based on MRI data analysis
Time frame: 2 time points:baseline, the end of the three-week treatment]
Change of Mini-Mental State Examination
Time frame: 3 time points: baseline, the end of the three-week treatment，3 months after ECT or drugs treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing ECT treatment and Drug treatment in people with Schizophrenia, Bipolar Disorder, run by Xidian University.
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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Qin (86-02981891070, wqin@xidian.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Positive And Negative Syndrome Scale(PANSS)for Schizophrenia; (time frame: 3 time points: baseline, the end of the three-week treatment，3 months after ECT or drugs treatment). The study lists 4 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 29 Aug 2018.