Comparison of the Efficacy, Safety, and Relapse of ECT to ECT Plus Agomelatine for Depressed Patients

November 27, 2019 updated by: Ching-Hua Lin, MD, PhD, Kaohsiung Kai-Suan Psychiatric Hospital

A Randomized, Double-blind, Comparison of the Efficacy, Safety, and Relapse of Electroconvulsive Therapy (ECT) to ECT Plus Agomelatine in the Treatment of Patients With Major Depressive Disorder

Our hypothesis is that using antidepressants during the ECT has a better efficacy and longer time to relapse/recurrence to the ECT without antidepressants. The purpose of this study is to compare the efficacy, safety, and time to relapse/recurrence of ECT to ECT plus agomelatine in the treatment of patients with major depressive disorder. Inpatients with major depressive disorder for ECT will be randomly assigned to double-blind treatment with placebo or agomelatine 50 mg/d.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Objective: Electroconvulsive therapy (ECT) is the safe and the most effective treatment for patients with major depressive disorder. It is still inconclusive whether antidepressants are continued during the course ot ECT. In terms of efficacy and safety, three essential questions arise: 1) does concomitant treatment improve the short-term antidepressant effects of ECT, 2) does concomitant treatment reduce the rate of early relapse/recurrence following ECT, 3) does concomitant treatment has more side effects? The purpose of this study is to conduct a clinical trial to compare the efficacy, safety, and time to relapse/recurrence of ECT to ECT plus agomelatine in the treatment of patients with major depressive disorder.

Methods: This is a prospective study. Inpatients with major depressive disorder for ECT will be randomly assigned to double-blind treatment with placebo or agomelatine 50 mg/d. After the ECT, the patients who meet the response criteria (i.e., at least a 50% reduction in symptom scores) or receive at least 6 treatments (i.e., acute phase) will receive the agomelatine 50 mg/d for 3 months (i.e., follow-up phase). The severity of depression, severity of anxiety, psychosocial functioning and side effects will be measured using the 17-item Hamilton Rating Scale for Depression (HAMD-17), the Clinical Global Impression-Severity (CGI-S), Depression and Somatic Symptoms Scale (DSSS), Zung's Depression Scale (ZDS), Hamilton Anxiety Rating Scale (HAM-A), Global Assessment of Functioning (GAF), Work and Social Adjustment Scale (WSAS), and UKU Side Effect Rating Scale before ECT, after every 3 sessions of ECT, at the end of acute ECT, and monthly during the 3-month follow-up period. Medical Outcomes Study Short-Form 36, Arizona Sexual Experiences Scale(ASEX), MINI Mental State Examination (MMSE), neuropsychological tests, and electroencephalography will be assessed before ECT, after ECT, and after the 3-month follow-up period. Questionnaire for patient attitudes about ECT after acute ECT will be completed. The Pearson chi-square test will be used to compare the response rate and remission (i.e., HAM-17≦7) rate between two groups. Analyses of group differences in efficacy will be performed by generalized estimating equations or ANCOVA. Survival analysis will be used to compare the time to response/remission and time to relapse/recurrence (i.e., HAM-D-17≧14 or CGI-S ≧4 or rehospitalization) after ECT between two groups.

Expected results: The results will provide evidence base for clinicians to decide to use antidepressants during ECT or not.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
97

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 886
        • Kaohsiung Municipal Kai-Syuan Psychiatric Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Major depressive disorder
  • Aged 18 years or older
  • HAMD-17 >=18
  • CGI-S >=4
  • Treatment-resistant depression: a lack of response to two or more adequate trials of different classes of antidepressants
  • Given written informed consent

Exclusion Criteria:

  • History of schizophrenia, schizoaffective disorder or organic mental disorders
  • Severe cognitive impairment
  • Female subjects with lactation or pregnancy
  • Serious medical conditions or neurological illnesses that restricte the use of ECT
  • Receiving ECT within the 6 months
  • Substance abuse/dependence within the 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: electroconvulsive therapy + agomelatine
electroconvulsive therapy 2 times weekly + agomelatine 50 mg daily
Other: electroconvulsive therapy
electroconvulsive therapy 2 times weekly
Other Names:
  • ECT
Drug: agomelatine
agomelatine
ACTIVE_COMPARATOR: electroconvulsive therapy + placebo
electroconvulsive therapy 2 times weekly + placebo
Drug: Placebo
placebo
Other: electroconvulsive therapy
electroconvulsive therapy 2 times weekly
Other Names:
  • ECT

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
17-item Hamilton Rating Scale for Depression (HAMD-17)
Time Frame: up to month 3.
The HAMD-17 is widely used in clinical setting to evaluate depression symptoms in the past week. Higher total HAMD-17 scores (ranging from 0 to 52) indicate more severe depression.
up to month 3.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical severity by Clinical Global Impression-Severity (CGI-S)
Time Frame: In acute phase, the CGI-S is rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination). In follow-up phase, the CGI-S is rated at months 1, 2, and 3.
The CGI-S is developed for use in NIMH-sponsored clinical trials to provide a brief, stand-alone assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication. The CGI comprises one-item measures evaluating the severity of psychopathology from 1 to 7 and higher scores indicate higher severity.
In acute phase, the CGI-S is rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination). In follow-up phase, the CGI-S is rated at months 1, 2, and 3.
Work and Social Adjustment Scale (WSAS)
Time Frame: In acute phase, the WSAS is rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination). In follow-up phase, the WSAS is rated at months 1, 2, and 3.
The Work and Social Adjustment Scale (WSAS) is a 5-item self-rating scale designed to measure psychosocial functional impairment. Each item is scored from 0 (not affected at all) to 8 (severely affected).
In acute phase, the WSAS is rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination). In follow-up phase, the WSAS is rated at months 1, 2, and 3.
UKU side effects rating scale
Time Frame: In acute phase, the UKU scale is rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination). In follow-up phase, the UKU scale is rated at months 1, 2, and 3.
UKU side effects rating scale, with the score of each item ranging from 0 (none) to 3 (severe), is used to measure adverse events during the study period.
In acute phase, the UKU scale is rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination). In follow-up phase, the UKU scale is rated at months 1, 2, and 3.
Electroencephalograph (EEG)
Time Frame: In acute phase, the EEG is recorded at baseline and again at week 6 (or on early termination). In follow-up phase, the EEG is recorded at month 3.
The EEG is used to analyze the change of electroencephalogram complexity. EEG The recording lasted about 3 minutes after habituation to environment, and the EEG technician monitored subject vigilance. Recordings are in 19 electrodes (Fp1, Fp2, F7, F3, Fz, F4, F8, T7, C3, Cz, C4, T8, P7, P3, Pz, P4, P8, O1, O2) in the standard 10-20 International placement with mastoid reference. The raw EEG signal is transposed to MATLAB software (MathWorks Inc., Natick, MA, USA) for processing. Each electrode complexity will be calculated.
In acute phase, the EEG is recorded at baseline and again at week 6 (or on early termination). In follow-up phase, the EEG is recorded at month 3.
Medical Outcomes Study Short-Form 36 (SF-36)
Time Frame: In acute phase, the SF-36 is rated at baseline and again at week 6 (or on early termination). In follow-up phase, the SF-36 is rated at month 3.
The SF-36 is used to assay the quality of life. Scores for the 8 SF-36 subscales range from 0 to 100, with a higher score representing better QOL.
In acute phase, the SF-36 is rated at baseline and again at week 6 (or on early termination). In follow-up phase, the SF-36 is rated at month 3.
Mini Mental State Examination (MMSE)
Time Frame: In acute phase, the MMSE is administered at baseline and again at week 6 (or on early termination). In follow-up phase, the MMSE is administered at month 3.
The MMSE used to assay the cognitive function. It consists of 30 points. Lower scores indicate poorer performance and greater cognitive impairment. The total score ranges from 0 to 30.
In acute phase, the MMSE is administered at baseline and again at week 6 (or on early termination). In follow-up phase, the MMSE is administered at month 3.
Arizona Sexual Experiences Scale (ASEX)
Time Frame: In acute phase, the ASEX is rated at baseline and again at week 6 (or on early termination). In follow-up phase, the ASEX is rated at month 3.
The ASEX is used to assay the sexual dysfunction. The ASEX taps five domains of sexual function using 6-point Likert scales scored from 1 (hyperfunction) to 6 (extreme hypofunction) to yield a total score ranging from 5 to 30.
In acute phase, the ASEX is rated at baseline and again at week 6 (or on early termination). In follow-up phase, the ASEX is rated at month 3.
Depression and Somatic Symptoms Scale (DSSS)
Time Frame: In acute phase, the DSSS is rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination). In follow-up phase, the DSSS is rated at months 1, 2, and 3.
The DSSS, a self-rating scale, is used to assay the severity of depression. The DSSS contains 22 items. Item responses are ranked from 0 to 3, with higher scores corresponding to more severe depression.
In acute phase, the DSSS is rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination). In follow-up phase, the DSSS is rated at months 1, 2, and 3.
The Wechsler Memory Scale (WMS).
Time Frame: In acute phase, the WMS is administered at baseline and again at week 6 (or on early termination). In follow-up phase, The WMS is administered at month 3.
The WMS is designed to measure different memory functions. Higher scores indicate higher memory functions.
In acute phase, the WMS is administered at baseline and again at week 6 (or on early termination). In follow-up phase, The WMS is administered at month 3.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kaohsiung Kai-Suan Psychiatric Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Science and Technology, Taiwan
Department of Health, Executive Yuan, R.O.C. (Taiwan)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 3, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 8, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 22, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MOST-103-2314-B-280-001-MY3
  • KSPH-2013-36 (OTHER: Kaohsiung Municipal Kai-Syuan Psychiatric Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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