CompletedPhase 4

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

Taiwan97 participantsStarted 2014-03-03

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

17-item Hamilton Rating Scale for Depression (HAMD-17)

Timeframe: up to month 3.

Trial details

NCT IDNCT04181567

SponsorKaohsiung Kai-Suan Psychiatric Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2019-10-08

View on ClinicalTrials.gov More Major Depressive Disorder trials