Clinical trial NCT04181567: Comparison of the Efficacy, Safety, and Relapse of ECT to ECT Plus Agomelatine for Depressed Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Keywords: electroconvulsive therapy
agomelatine
relapse
major depressive disorder
response
Lead sponsor: Kaohsiung Kai-Suan Psychiatric Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Department of Health, Executive Yuan, R.O.C. (Taiwan)
name: Ministry of Science and Technology, Taiwan
First posted: 2019-11-29
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 17-item Hamilton Rating Scale for Depression (HAMD-17)
timeFrame: up to month 3.
Secondary outcomes:
measure: Clinical severity by Clinical Global Impression-Severity (CGI-S)
timeFrame: 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.
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: 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.
measure: UKU side effects rating scale
timeFrame: 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.
measure: Electroencephalograph (EEG)
timeFrame: 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.
measure: Medical Outcomes Study Short-Form 36 (SF-36)
timeFrame: 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.
measure: Mini Mental State Examination (MMSE)
timeFrame: 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.
measure: Arizona Sexual Experiences Scale (ASEX)
timeFrame: 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.
measure: Depression and Somatic Symptoms Scale (DSSS)
timeFrame: 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.
measure: The Wechsler Memory Scale (WMS).
timeFrame: 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.
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Municipal Kai-Syuan Psychiatric Hospital
Study officials:
References:
citation: 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.