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

NCT ID: NCT04181567

Last Updated: 2019-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-03

Study Completion Date

2019-11-22

Brief Summary

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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

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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.

Conditions

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Major Depressive Disorder

Keywords

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electroconvulsive therapy agomelatine relapse major depressive disorder response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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electroconvulsive therapy + agomelatine

electroconvulsive therapy 2 times weekly + agomelatine 50 mg daily

Group Type EXPERIMENTAL

electroconvulsive therapy

Intervention Type OTHER

electroconvulsive therapy 2 times weekly

agomelatine

Intervention Type DRUG

agomelatine

electroconvulsive therapy + placebo

electroconvulsive therapy 2 times weekly + placebo

Group Type ACTIVE_COMPARATOR

electroconvulsive therapy

Intervention Type OTHER

electroconvulsive therapy 2 times weekly

Placebo

Intervention Type DRUG

placebo

Interventions

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electroconvulsive therapy

electroconvulsive therapy 2 times weekly

Intervention Type OTHER

agomelatine

agomelatine

Intervention Type DRUG

Placebo

placebo

Intervention Type DRUG

Other Intervention Names

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ECT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Department of Health, Executive Yuan, R.O.C. (Taiwan)

OTHER_GOV

Sponsor Role collaborator

Ministry of Science and Technology, Taiwan

OTHER_GOV

Sponsor Role collaborator

Kaohsiung Kai-Suan Psychiatric Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ching-Hua Lin, MD, PhD

Chief of Adult Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kaohsiung Municipal Kai-Syuan Psychiatric Hospital

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

References

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Lin CH, Yang WC, Chan MH, Chen CC. The Relationship Between Depression and Pain During Acute Electroconvulsive Therapy and Follow-Up Period for Patients With Treatment-Resistant Depression. J ECT. 2022 Sep 1;38(3):192-199. doi: 10.1097/YCT.0000000000000830. Epub 2022 Mar 1.

Reference Type DERIVED
PMID: 35220359 (View on PubMed)

Other Identifiers

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KSPH-2013-36

Identifier Type: OTHER

Identifier Source: secondary_id

MOST-103-2314-B-280-001-MY3

Identifier Type: -

Identifier Source: org_study_id