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

NCT04181567 | Completed Phase 4 DMC

• 2 other identifiers: MOST-103-2314-B-280-001-MY3KSPH-2013-36
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

electroconvulsive therapy; agomelatine; relapse; major depressive disorder; response

Outcome Measures

Primary Outcomes (1)

• 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.

  up to month 3.

Secondary Outcomes (9)

• Clinical severity by Clinical Global Impression-Severity (CGI-S)

  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)

  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

  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)

  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)

  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.

Study Arms (2)

electroconvulsive therapy + agomelatine

EXPERIMENTAL

electroconvulsive therapy 2 times weekly + agomelatine 50 mg daily

Other: electroconvulsive therapy; Drug: agomelatine

electroconvulsive therapy + placebo

ACTIVE COMPARATOR

electroconvulsive therapy 2 times weekly + placebo

Other: electroconvulsive therapy; Drug: Placebo

Interventions

electroconvulsive therapy OTHER

electroconvulsive therapy 2 times weekly

Also known as: ECT

electroconvulsive therapy + agomelatine; electroconvulsive therapy + placebo

agomelatine DRUG

agomelatine

electroconvulsive therapy + agomelatine

Placebo DRUG

placebo

electroconvulsive therapy + placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaohsiung Kai-Suan Psychiatric Hospital: lead
• Department of Health, Executive Yuan, R.O.C. (Taiwan): collaborator
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

Kaohsiung Municipal Kai-Syuan Psychiatric Hospital

Kaohsiung City, 886, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 35220359 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Recurrence

Interventions

Electroconvulsive Therapy; agomelatine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Adult Psychiatry

Study Record Dates

• First Submitted: November 24, 2019
• First Posted: November 29, 2019
• Study Start: March 3, 2014
• Primary Completion: October 8, 2019
• Study Completion: November 22, 2019
• Last Updated: November 29, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)