Major Depressive DisorderNCT02066077
The Efficacy And Cognitive Impairment Of Modified Electroconvulsive Therapy
A study testing Etomidate, Propofol and Bilateral temporal MECT in people with Major Depressive Disorder, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
1. To determine the influencing factors of modified electroconvulsive therapy (MECT); 2. To determine the influencing factors and reversibility of the cognitive impairment caused by MECT; 3. To determine the duration of efficacy of MECT and its affecting factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Etomidate, Propofol and Bilateral temporal MECT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2013to 31 Dec 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged over 18 years (when informed consent was got), male or female
- Meet International Classification of Diseases-10(ICD-10) diagnostic criteria for depression
- Scored 18 or above on the HAM-D Scale which included 17 items
- Clinical Global Impression(CGI)-severity score ≥ 4
- Provided written informed consent
Who cannot join
- Any depressive disorders not due to major depressive disorder
- Meet other diagnosis criteria in Diagnostic and Statistical Manual of Mental Disorders-IV-Test Revision(DSM-IV-TR) Axis I
- With a history of acute or chronic renal failure, liver cirrhosis or active hepatopathy
- With clinically significant abnormal results of laboratory test, which are considered to have impact on treatment efficacy and the safety of participants
- With a history of severe or unstable physical disease including nervous system disease and myocardial infarction
- Undergoing alcoholism or alcohol (or substance) abuse during 30 days or 6 months before the trial
Show all 12Show fewer
- With no response to previous ECT treatment
- Received transcranial magnetic stimulation treatment in the last 6 months
- Allergic to propofol, etomidate and succinylcholine chloride
- During pregnancy or lactation
- With a history of stroke in the last month
- Enrolled in any other clinical trial 30 days prior to the baseline
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy And Cognitive Impairment Of Modified Electroconvulsive Therapy: A Randomized Clinical Trial And Its Standard Technology Promotion Research
- To determine the influencing factors of modified electroconvulsive therapy (MECT);
- To determine the influencing factors and reversibility of the cognitive impairment caused by MECT;
- To determine the duration of efficacy of MECT and its affecting factors.
- Conditions
- Major Depressive Disorder
- Being tested
- Etomidate, Propofol, Bilateral temporal MECT, The right temporal MECT, Bilateral frontal MECT
- Keywords
- Major Depressive Disorder, Modified Electroconvulsive Therapy, Cognition, Memory
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtomidateDrug
PropofolDrug
Bilateral temporal MECTDevice
The right temporal MECTDevice
Bilateral frontal MECTDevice
| Study group | Role | What they receive |
|---|---|---|
| Bilateral temporal and propofol | Experimental | During the MECT treatment, electrodes are placed at bilateral temporal, with propofol 2mg/kg to Induce anesthesia. Receives: Drug: Propofol; Device: Bilateral temporal MECT |
| Bilateral temporal and etomidate | Experimental | During the MECT treatment, electrodes are placed at bilateral temporal, with etomidate 0.3mg/kg to Induce anesthesia. Receives: Drug: Etomidate; Device: Bilateral temporal MECT |
| The right temporal and propofol | Experimental | During the MECT treatment, electrodes are placed at the right temporal, with propofol 2mg/kg to Induce anesthesia. Receives: Drug: Propofol; Device: The right temporal MECT |
| The right temporal and etomidate | Experimental | During the MECT treatment, electrodes are placed at the right temporal, with etomidate 0.3mg/kg to Induce anesthesia. Receives: Drug: Etomidate; Device: The right temporal MECT |
| Bilateral frontal and propofol | Experimental | During the MECT treatment, electrodes are placed at bilateral frontal, with propofol 2mg/kg to Induce anesthesia. Receives: Drug: Propofol; Device: Bilateral frontal MECT |
| Bilateral frontal and etomidate | Experimental | During the MECT treatment, electrodes are placed at bilateral frontal, with etomidate 0.3mg/kg to Induce anesthesia. Receives: Drug: Etomidate; Device: Bilateral frontal MECT |
| Standard-therapy Group | Active comparator | During the MECT treatment, electrodes are placed at bilateral temporal, with etomidate 0.3mg/kg to Induce anesthesia. Receives: Drug: Etomidate; Device: Bilateral temporal MECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hamilton Depression Scale(HAMD) Scores
Measured: Change from Baseline in Hamilton Depression Scale scores at 7d, 14d, 21d, 28d, 35d, 42d and 180d after the last MECT session
Change in Wechsler Memory Scale (WMS) Scores as a Measure of Safety
Measured: Change from Baseline in Wechsler Memory Scale (WMS) Scores at 42d and 180d after the last MECT session
Secondary outcomes (6)
Young Manic Rating Scale(MMSE) as a Measure for Evaluation of Mania State
Measured: 42d and 180d after the last MECT session
Resting-state/Task-state functional magnetic resonance imaging (fMRI)
Measured: Change form Baseline in Resting-state/Task-state fMRI Imging Results at 42d and 180d after the last MECT session
Change in Hamilton Anxiety Scale(HAMA) Scores
Measured: Change from Baseline in Hamilton Anxiety Scale Scores at 7d, 14d, 21d, 28d, 35d, 42d and 180d after the last MECT session
Change in Clinical Global Impression-severity of illness(CGI-SI) Scores as a Measure of Efficacy
Measured: Change from Baseline in CGI-SI Scores at 7d, 14d, 21d, 28d, 35d, 42d and 180d after the last MECT session
Change in Wisconsin Card Sorting Test(WCST) Scores as a Measure of Safety
Measured: Change from Baseline in Wisconsin Card Sorting Test(WCST) Scores at 42d and 180d after the last MECT session
Change in P300/P50 Event-Related Potentials(ERP)
Measured: Change from Baseline in P300/P50 Event-Related Potentials(ERP) at 42d and 180d after after the last MECT session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study start1 Jan 2013
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Tongji Hospital, Huashan Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066077
- Sponsor's protocol ID
- SHDC12012109
- Status last verified
- Dec 2017
- First submitted
- 13 Feb 2014
- Last updated
- 23 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy And Cognitive Impairment Of Modified Electroconvulsive Therapy: A Randomized Clinical Trial And Its Standard Technology Promotion Research
- ClinicalTrials.gov ID
- NCT02066077
- Acronym / sponsor ID
- SHDC12012109
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, Modified Electroconvulsive Therapy, Cognition, Memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Tongji Hospital, Huashan Hospital
- Study start
- 1 Jan 2013
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 19 Feb 2014 (estimated)
- 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.
- To determine the influencing factors of modified electroconvulsive therapy (MECT);
- To determine the influencing factors and reversibility of the cognitive impairment caused by MECT;
- To determine the duration of efficacy of MECT and its affecting factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Bilateral temporal and propofol | Experimental | Drug: Propofol, Device: Bilateral temporal MECTDuring the MECT treatment, electrodes are placed at bilateral temporal, with propofol 2mg/kg to Induce anesthesia. |
| Bilateral temporal and etomidate | Experimental | Drug: Etomidate, Device: Bilateral temporal MECTDuring the MECT treatment, electrodes are placed at bilateral temporal, with etomidate 0.3mg/kg to Induce anesthesia. |
| The right temporal and propofol | Experimental | Drug: Propofol, Device: The right temporal MECTDuring the MECT treatment, electrodes are placed at the right temporal, with propofol 2mg/kg to Induce anesthesia. |
| The right temporal and etomidate | Experimental | Drug: Etomidate, Device: The right temporal MECTDuring the MECT treatment, electrodes are placed at the right temporal, with etomidate 0.3mg/kg to Induce anesthesia. |
| Bilateral frontal and propofol | Experimental | Drug: Propofol, Device: Bilateral frontal MECTDuring the MECT treatment, electrodes are placed at bilateral frontal, with propofol 2mg/kg to Induce anesthesia. |
| Bilateral frontal and etomidate | Experimental | Drug: Etomidate, Device: Bilateral frontal MECTDuring the MECT treatment, electrodes are placed at bilateral frontal, with etomidate 0.3mg/kg to Induce anesthesia. |
| Standard-therapy Group | Active comparator | Drug: Etomidate, Device: Bilateral temporal MECTDuring the MECT treatment, electrodes are placed at bilateral temporal, with etomidate 0.3mg/kg to Induce anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged over 18 years (when informed consent was got), male or female
- Meet International Classification of Diseases-10(ICD-10) diagnostic criteria for depression
- Scored 18 or above on the HAM-D Scale which included 17 items
- Clinical Global Impression(CGI)-severity score ≥ 4
- Provided written informed consent
Key exclusion criteria (12 listed)
- Any depressive disorders not due to major depressive disorder
- Meet other diagnosis criteria in Diagnostic and Statistical Manual of Mental Disorders-IV-Test Revision(DSM-IV-TR) Axis I
- With a history of acute or chronic renal failure, liver cirrhosis or active hepatopathy
- With clinically significant abnormal results of laboratory test, which are considered to have impact on treatment efficacy and the safety of participants
- With a history of severe or unstable physical disease including nervous system disease and myocardial infarction
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 |
|---|---|---|
| Etomidate | Drug | Bilateral frontal and etomidate, Bilateral temporal and etomidate, Standard-therapy Group, The right temporal and etomidate |
| Propofol | Drug | Bilateral frontal and propofol, Bilateral temporal and propofol, The right temporal and propofol |
| Bilateral temporal MECT | Device | Bilateral temporal and etomidate, Bilateral temporal and propofol, Standard-therapy Group |
| The right temporal MECT | Device | The right temporal and etomidate, The right temporal and propofol |
| Bilateral frontal MECT | Device | Bilateral frontal and etomidate, Bilateral frontal and propofol |
Primary outcome
Change in Hamilton Depression Scale(HAMD) Scores
Time frame: Change from Baseline in Hamilton Depression Scale scores at 7d, 14d, 21d, 28d, 35d, 42d and 180d after the last MECT session
Change in Wechsler Memory Scale (WMS) Scores as a Measure of Safety
Time frame: Change from Baseline in Wechsler Memory Scale (WMS) Scores at 42d and 180d after the last MECT session
6 secondary outcomes
Young Manic Rating Scale(MMSE) as a Measure for Evaluation of Mania State
Time frame: 42d and 180d after the last MECT session
Resting-state/Task-state functional magnetic resonance imaging (fMRI)
Time frame: Change form Baseline in Resting-state/Task-state fMRI Imging Results at 42d and 180d after the last MECT session
Change in Hamilton Anxiety Scale(HAMA) Scores
Time frame: Change from Baseline in Hamilton Anxiety Scale Scores at 7d, 14d, 21d, 28d, 35d, 42d and 180d after the last MECT session
Change in Clinical Global Impression-severity of illness(CGI-SI) Scores as a Measure of Efficacy
Time frame: Change from Baseline in CGI-SI Scores at 7d, 14d, 21d, 28d, 35d, 42d and 180d after the last MECT session
Change in Wisconsin Card Sorting Test(WCST) Scores as a Measure of Safety
Time frame: Change from Baseline in Wisconsin Card Sorting Test(WCST) Scores at 42d and 180d after the last MECT session
Change in P300/P50 Event-Related Potentials(ERP)
Time frame: Change from Baseline in P300/P50 Event-Related Potentials(ERP) at 42d and 180d after after the last MECT session
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 23 Apr 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Etomidate, Propofol and Bilateral temporal MECT in people with Major Depressive Disorder, 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 12 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 23 Apr 2018. 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 Hamilton Depression Scale(HAMD) Scores (time frame: Change from Baseline in Hamilton Depression Scale scores at 7d, 14d, 21d, 28d, 35d, 42d and 180d after the last MECT session). 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 23 Apr 2018.