Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-02 @ 12:21 AM
Study NCT ID:
NCT04181567
Status:
COMPLETED
Last Update Posted:
2019-11-29
First Post:
2019-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Efficacy, Safety, and Relapse of ECT to ECT Plus Agomelatine for Depressed Patients
Sponsor:
Kaohsiung Kai-Suan Psychiatric Hospital
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| KSPH-2013-36 | OTHER | Kaohsiung Municipal Kai-Syuan Psychiatric Hospital | View |