Major Depressive EpisodePhase 4NCT02032576
Predictors of the Response and Relapse/Recurrence After ECT for Depressed Patients
A Phase 4 study testing ECT for depressed patients in people with Major Depressive Episode, run by Kaohsiung Kai-Suan Psychiatric Hospital at 1 site in Taiwan.
Trial summary
Objective: Psychiatrists have long sought a quantifiable biomarker of electroconvulsive therapy (ECT) response. Although ECT is highly effective for treatment of patients with major depressive episode, a high rate of relapse/recurrence is a major problem after discontinuation of ECT. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Major Depressive Episode
- What is being tested?
- ECT for depressed patients
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2008to Dec 2013
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of major depressive disorder or bipolar depression
- Poor drug response
- Severity or urgency of illness
Who cannot join
- Subjects cannot write the imform consents
- Subjects with severe physical illness
Trial locations and contacts
1 site in 1 country.
About this study
Objective: Psychiatrists have long sought a quantifiable biomarker of electroconvulsive therapy (ECT) response. Although ECT is highly effective for treatment of patients with major depressive episode, a high rate of relapse/recurrence is a major problem after discontinuation of ECT. The purpose of this study is to examine the factors related to the response of ECT, to predict ECT response early, and to investigate the clinical predictors affecting the time to relapse/recurrence after ECT.
Methods: Patients with major depressive episode who require ECT treatment will be enrolled. ECT will be performed regularly. The 17-item Hamilton Rating Scale for Depression (HAMD-17) and other scales will be assessed before ECT, after every 10 days, till to an expected average of 50 days, and monthly during the 6-month follow-up period. Other measures also will be performed before the first ECT, at an expected average of 50 days, and at the end of follow-up period. Predictors of the response and relapse/recurrence after ECT and early prediction of ECT response will be obtained by statistic methods.
Read the detailed description
Objective: Electroconvulsive therapy (ECT) is a safe and the most effective treatment for patients with major depressive episode, but the mechanism underlying the therapeutic action of this treatment is still unknown. Psychiatrists have long sought a quantifiable biomarker of ECT treatment response. Till now, no biomarker of ECT is used in clinical practice, but potential biomarkers that have been studied include brain-derived neurotrophic factor (BDNF), DNA polymorphism, RNA, electroencephalogram (EEG), auditory evoked potential (AEP), and cognitive function test. Although ECT is highly effective for treatment of major depressive episode, a high rate of relapse/recurrence is a major problem after discontinuation of ECT. The purpose of this study is to examine the factors related to the response of ECT for patients with major depressive episode, to predict the ECT response, and to investigate the clinical predictors affecting the time to relapse/recurrence after ECT.
Methods: Subjects with major depressive episode diagnosed according to DSM-IV criteria who require ECT treatment will be enrolled for study. ECT will be performed regularly using a brief-pulse, constant-current device. ECT will be given two or three times a week. The 17-item Hamilton Rating Scale for Depression (HAMD-17), Clinical Global Impression-severity (CGI-S), global assessment scale (GAF), UKU side effect rating scale and other scales will be assessed before ECT, after every 10 days, till to an expected average of 50 days, and monthly during the 6-month follow-up period. Response will be defined as a reduction of 60% or more of the HAMD-17 score after treatment. Other measures collected before ECT and at an expected average of 50 days include Zung's Depression Scale (SDS), Short-Form 36 (SF-36), Work and Social Adjustment Scale (WSAS), plasma BDNF level, auditory evoked potentials (AEP), electroencephalography (EEG), neuropsychological test, and RNA. After ECT, CGI-S, HAMD-17, GAF and WSAS are reexamined monthly for 6 months. The definition of relapse/recurrence will be readmission, a HAM-D-17 score at least 18, or a CGI-S score at least 4 during the follow-up period. A logistic regression model will be used to obtain the predictors for ECT response. To establish the early prediction of ECT response, receiver operating characteristic curve (ROC) will be used to determine the cutoff point. Possible predictors related to relapse/recurrence will be analyzed using the Cox proportional hazards regression model.
- Conditions
- Major Depressive Episode
- Being tested
- ECT for depressed patients
- Keywords
- major depressive episode, electroconvulsive therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECT for depressed patientsDevice
Also called bilateral ECT with a bipolar brief pulse square wave
electroconvulsive therapy with a bipolar brief pulse square wave
| Study group | Role | What they receive |
|---|---|---|
| ECT for depressed patients | Experimental | electroconvulsive therapy with a bipolar brief pulse square wave Receives: Device: ECT for depressed patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictors of ECT response
Response will be defined as a reduction of 60% or more of the HAMD-17 score after treatment. Potential factors related to ECT response will be assayed. Early prediction model of response will be established.
Measured: an expected average of 50 days after initiation of ECT
Predictors of relapse/recurrence after ECT
The definition of relapse/recurrence of the major depressive episode will be readmission or a HAMD-17 score at least 18. Predictors (demographic and clinical variables) associated with time to relapse/recurrence during the 6-month follow-up period will be assayed using survival analysis.
Measured: After ECT, HAMD-17 will be assessed monthly until the relapse/recurrence of the major depressive episode during the 6-month follow-up period.
Secondary outcomes (8)
The changes of plasma brain-derived neurotrophic factor (BDNF) level after ECT
The association between response and the change of BDNF will be examined.
Measured: Prior to undergoing the first ECT and at an expected average of 50 days, plasma BDNF will be tested.
The changes of cognitive functions after ECT
The impact of ECT on cognitive functions will be assayed.
Measured: Neuropsychological test will be performed before the first ECT and at an expected average of 50 days.
Assessments of safety for general adverse events after ECT
General adverse events were evaluated by a standardized the UKU Side Effect Rating Scale.
Measured: UKU Side Effect Rating Scale will be assessed before ECT, after every 10 days, till to an expected average of 50 days.
The changes of quality of life after ECT
The association between response and the change of SF-36 will be examined.
Measured: Short-Form 36 (SF-36) will be examined before the first ECT and at an expected average of 50 days.
The changes of psychosocial functioning after ECT
The association between response and the change of WSAS will be examined.
Measured: Work and Social Adjustment Scale (WSAS) will be examined before the first ECT and at an expected average of 50 days.
The changes of auditory evoked potentials (AEP) after ECT
The association between response and the change of AEP will be examined.
Measured: Prior to undergoing the first ECT and at an expected average of 50 days, AEP will be tested.
The changes of electroencephalography (EEG) after ECT
The impact of ECT on EEG will be assayed.
Measured: Prior to undergoing the first ECT and at an expected average of 50 days, EEG will be tested.
The changes of RNA after ECT
The association between response and the change of RNA will be examined.
Measured: Prior to undergoing the first ECT and at an expected average of 50 days, RNA will be extracted from the blood.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startJan 2008
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Major Depressive EpisodeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Kai-Suan Psychiatric Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ching-Hua Lin, MD, PhD, Kaohsiung Kai-Suan Psychiatric Hospital
- Investigators
- Ching-Hua Lin, M.D., Study chair, Kai-Suan Psychiatric Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032576
- Sponsor's protocol ID
- KSPH-2008-12
- Status last verified
- Jan 2014
- First submitted
- 3 Jun 2012
- Last updated
- 10 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wahlund B, von Rosen D. ECT of major depressed patients in relation to biological and clinical variables: a brief overview. Neuropsychopharmacology. 2003 Jul;28 Suppl 1:S21-6. doi: 10.1038/sj.npp.1300135.
PubMed 12827140Bourgon LN, Kellner CH. Relapse of depression after ECT: a review. J ECT. 2000 Mar;16(1):19-31. doi: 10.1097/00124509-200003000-00003.
PubMed 10735328Marano CM, Phatak P, Vemulapalli UR, Sasan A, Nalbandyan MR, Ramanujam S, Soekadar S, Demosthenous M, Regenold WT. Increased plasma concentration of brain-derived neurotrophic factor with electroconvulsive therapy: a pilot study in patients with major depression. J Clin Psychiatry. 2007 Apr;68(4):512-7. doi: 10.4088/jcp.v68n0404.
PubMed 17474805
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of the Response and Relapse/Recurrence After ECT for Depressed Patients
- ClinicalTrials.gov ID
- NCT02032576
- Acronym / sponsor ID
- KSPH-2008-12
- Conditions
- Major Depressive Episode
- Keywords
- major depressive episode, electroconvulsive therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Kaohsiung Kai-Suan Psychiatric HospitalOther government
- Study start
- Jan 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 10 Jan 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.
Objective: Psychiatrists have long sought a quantifiable biomarker of electroconvulsive therapy (ECT) response. Although ECT is highly effective for treatment of patients with major depressive episode, a high rate of relapse/recurrence is a major problem after discontinuation of ECT. The purpose of this study is to examine the factors related to the response of ECT, to predict ECT response early, and to investigate the clinical predictors affecting the time to relapse/recurrence after ECT.
Methods: Patients with major depressive episode who require ECT treatment will be enrolled. ECT will be performed regularly. The 17-item Hamilton Rating Scale for Depression (HAMD-17) and other scales will be assessed before ECT, after every 10 days, till to an expected average of 50 days, and monthly during the 6-month follow-up period. Other measures also will be performed before the first ECT, at an expected average of 50 days, and at the end of follow-up period. Predictors of the response and relapse/recurrence after ECT and early prediction of ECT response will be obtained by statistic methods.
Detailed description
Objective: Electroconvulsive therapy (ECT) is a safe and the most effective treatment for patients with major depressive episode, but the mechanism underlying the therapeutic action of this treatment is still unknown. Psychiatrists have long sought a quantifiable biomarker of ECT treatment response. Till now, no biomarker of ECT is used in clinical practice, but potential biomarkers that have been studied include brain-derived neurotrophic factor (BDNF), DNA polymorphism, RNA, electroencephalogram (EEG), auditory evoked potential (AEP), and cognitive function test. Although ECT is highly effective for treatment of major depressive episode, a high rate of relapse/recurrence is a major problem after discontinuation of ECT. The purpose of this study is to examine the factors related to the response of ECT for patients with major depressive episode, to predict the ECT response, and to investigate the clinical predictors affecting the time to relapse/recurrence after ECT.
Methods: Subjects with major depressive episode diagnosed according to DSM-IV criteria who require ECT treatment will be enrolled for study. ECT will be performed regularly using a brief-pulse, constant-current device. ECT will be given two or three times a week. The 17-item Hamilton Rating Scale for Depression (HAMD-17), Clinical Global Impression-severity (CGI-S), global assessment scale (GAF), UKU side effect rating scale and other scales will be assessed before ECT, after every 10 days, till to an expected average of 50 days, and monthly during the 6-month follow-up period. Response will be defined as a reduction of 60% or more of the HAMD-17 score after treatment. Other measures collected before ECT and at an expected average of 50 days include Zung's Depression Scale (SDS), Short-Form 36 (SF-36), Work and Social Adjustment Scale (WSAS), plasma BDNF level, auditory evoked potentials (AEP), electroencephalography (EEG), neuropsychological test, and RNA. After ECT, CGI-S, HAMD-17, GAF and WSAS are reexamined monthly for 6 months. The definition of relapse/recurrence will be readmission, a HAM-D-17 score at least 18, or a CGI-S score at least 4 during the follow-up period. A logistic regression model will be used to obtain the predictors for ECT response. To establish the early prediction of ECT response, receiver operating characteristic curve (ROC) will be used to determine the cutoff point. Possible predictors related to relapse/recurrence will be analyzed using the Cox proportional hazards regression model.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECT for depressed patients | Experimental | Device: ECT for depressed patientselectroconvulsive therapy with a bipolar brief pulse square wave |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of major depressive disorder or bipolar depression
- Poor drug response
- Severity or urgency of illness
Key exclusion criteria (2 listed)
- Subjects cannot write the imform consents
- Subjects with severe physical illness
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 for depressed patientsAlso: bilateral ECT with a bipolar brief pulse square waveelectroconvulsive therapy with a bipolar brief pulse square wave | Device | ECT for depressed patients |
Primary outcome
Predictors of ECT response
Time frame: an expected average of 50 days after initiation of ECT
Response will be defined as a reduction of 60% or more of the HAMD-17 score after treatment. Potential factors related to ECT response will be assayed. Early prediction model of response will be established.
Predictors of relapse/recurrence after ECT
Time frame: After ECT, HAMD-17 will be assessed monthly until the relapse/recurrence of the major depressive episode during the 6-month follow-up period.
The definition of relapse/recurrence of the major depressive episode will be readmission or a HAMD-17 score at least 18. Predictors (demographic and clinical variables) associated with time to relapse/recurrence during the 6-month follow-up period will be assayed using survival analysis.
8 secondary outcomes
The changes of plasma brain-derived neurotrophic factor (BDNF) level after ECT
Time frame: Prior to undergoing the first ECT and at an expected average of 50 days, plasma BDNF will be tested.
The changes of cognitive functions after ECT
Time frame: Neuropsychological test will be performed before the first ECT and at an expected average of 50 days.
Assessments of safety for general adverse events after ECT
Time frame: UKU Side Effect Rating Scale will be assessed before ECT, after every 10 days, till to an expected average of 50 days.
The changes of quality of life after ECT
Time frame: Short-Form 36 (SF-36) will be examined before the first ECT and at an expected average of 50 days.
The changes of psychosocial functioning after ECT
Time frame: Work and Social Adjustment Scale (WSAS) will be examined before the first ECT and at an expected average of 50 days.
The changes of auditory evoked potentials (AEP) after ECT
Time frame: Prior to undergoing the first ECT and at an expected average of 50 days, AEP will be tested.
The changes of electroencephalography (EEG) after ECT
Time frame: Prior to undergoing the first ECT and at an expected average of 50 days, EEG will be tested.
The changes of RNA after ECT
Time frame: Prior to undergoing the first ECT and at an expected average of 50 days, RNA will be extracted from the blood.
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 10 Jan 2014.
- Results publication: PubMed 12827140Wahlund B, von Rosen D. ECT of major depressed patients in relation to biological and clinical variables: a brief overview. Neuropsychopharmacology. 2003 Jul;28 Suppl 1:S21-6. doi: 10.1038/sj.npp.1300135.
- Results publication: PubMed 10735328Bourgon LN, Kellner CH. Relapse of depression after ECT: a review. J ECT. 2000 Mar;16(1):19-31. doi: 10.1097/00124509-200003000-00003.
- Results publication: PubMed 17474805Marano CM, Phatak P, Vemulapalli UR, Sasan A, Nalbandyan MR, Ramanujam S, Soekadar S, Demosthenous M, Regenold WT. Increased plasma concentration of brain-derived neurotrophic factor with electroconvulsive therapy: a pilot study in patients with major depression. J Clin Psychiatry. 2007 Apr;68(4):512-7. doi: 10.4088/jcp.v68n0404.
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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.
Ching-Hua Lin, M.D. study chair
Kai-Suan Psychiatric Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ECT for depressed patients in people with Major Depressive Episode, run by Kaohsiung Kai-Suan Psychiatric Hospital at 1 site in Taiwan.
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 3 inclusion and 2 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 10 Jan 2014. 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 Taiwan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Predictors of ECT response (time frame: an expected average of 50 days after initiation of ECT). 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?
On the ClinicalTrials.gov record for NCT02032576, which also lists 3 linked publications.
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 10 Jan 2014.