A Phase 4 interventional study of electroconvulsive therapy and agomelatine in Major Depressive Disorder, sponsored by Kaohsiung Kai-Suan Psychiatric Hospital. Completed at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-29.
Sponsored by Kaohsiung Kai-Suan Psychiatric Hospital · Phase 4, Interventional, and Treatment
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.
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.
3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.
This study's enrollment of 97 is above the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Kaohsiung Kai-Suan Psychiatric Hospital is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
electroconvulsive therapy 2 times weekly + agomelatine 50 mg daily
Other: electroconvulsive therapy · Drug: agomelatine
electroconvulsive therapy 2 times weekly + placebo
Other: electroconvulsive therapy · Drug: Placebo
electroconvulsive therapy 2 times weekly
Also known as: ECT
agomelatine
placebo
17-item Hamilton Rating Scale for Depression (HAMD-17)
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.
Time frame: up to month 3.
Clinical severity by Clinical Global Impression-Severity (CGI-S)
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.
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.
Work and Social Adjustment Scale (WSAS)
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).
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.
UKU side effects rating scale
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.
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.
Electroencephalograph (EEG)
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.
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.
Medical Outcomes Study Short-Form 36 (SF-36)
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.
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.
Mini Mental State Examination (MMSE)
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.
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.
Arizona Sexual Experiences Scale (ASEX)
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.
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.
Depression and Somatic Symptoms Scale (DSSS)
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.
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 Wechsler Memory Scale (WMS).
The WMS is designed to measure different memory functions. Higher scores indicate higher memory functions.
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.
Plan to share: No
Ran from Mar 2014 to primary completion in Oct 2019, 67 months.
Of 79 non-industry phase 4 interventional studies under Depressive Disorder, Major, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 60. This study's 67 months is above that.
Counting every sponsor, half of 98 studies reached it within 35 months; a quarter within 20 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Agomelatine
Kaohsiung Kai-Suan Psychiatric Hospital