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

• Status: Completed
• Trial end date: 2019-11-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaohsiung Kai-Suan Psychiatric Hospital
• Collaborators: Department of Health, Executive Yuan, R.O.C. (Taiwan); Ministry of Science and Technology, Taiwan
• Treatments: S 20098

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.