Agomelatine Augmentation Added to SSRIs or SNRIs for Depression

Sponsor

Central South University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04589143

Collaborator

(none)

300

Enrollment

Location

Arms

Anticipated Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study was to evaluate the efficacy and safety of agomelatine augmentation antidepressant therapy in patients with major depressive disorder with inadequate response during early stage of treatment.

Condition or Disease	Intervention/Treatment	Phase
MDD	Drug: Agomelatine Drug: Placebos	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel AssignmentParallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Agomelatine Added to SSRIs or SNRIs for Early-nonresponsive Patients With Major Depressive Disorder: a Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial

Actual Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experience group In this group,participants take agomelatine at a dose of 25-50 mg/d for 8 weeks.	Drug: Agomelatine Oral tablets of agomelatine at a dose of 25-50 mg/d for 8 weeks
Placebo Comparator: Contral group In this group,participants take a placebo at a dose of 25-50 mg/d for 8 weeks.	Drug: Placebos Oral tablets of placebos at a dose of 25-50 mg/d for 8 weeks

Arm

Intervention/Treatment

Experimental: Experience group

In this group,participants take agomelatine at a dose of 25-50 mg/d for 8 weeks.

Drug: Agomelatine

Oral tablets of agomelatine at a dose of 25-50 mg/d for 8 weeks

Placebo Comparator: Contral group

In this group,participants take a placebo at a dose of 25-50 mg/d for 8 weeks.

Drug: Placebos

Oral tablets of placebos at a dose of 25-50 mg/d for 8 weeks

Outcome Measures

Primary Outcome Measures

Response rate [at baseline and in 2, 4 and 8 week]
The ratio of patients who achieved percentage improvement of HAMD17 score ≥50%
Remission rate [at baseline and in 2, 4 and 8 week]
The ratio of patients who achieved HAMD17 score ≤ 7 points

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

-1.Aged 18-60 years old; 2.Meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria for a current major depressive episode; 3.Inadequate response to antidepressants with at least 2-weeks treatment duration and under a standard dose. Inadequate response is defined by a < 20% in the percentage change of HAMD-17 score or according to patients' self-report in antidepressant treatment questionnaire. Standard dose is defined as follows: sertraline: >50mg; fluoxetine: >20 mg; citalopram: >20 mg; escitalopram: >10mg; venlafaxine: >150 mg; duloxetine: >60 mg; 4.Score of Clinical Global Impression-Severity (CGI-S) ≥4; 5.Educational level of junior high school and above, having the ability to give informed consent and complete cognitive tests.

6.The primary providers agreeing and patients willing to maintain current antidepressants with the adjunctive treatment of agomelatine.

Exclusion Criteria:

1.Current or history of a systematic medical condition (especially rheumatic-immune systemic diseases, endocrine and metabolism diseases, and neurologic system diseases), brain injury or loss of consciousness for more than 5 minutes; 2.Significant current suicidal ideation or suicidal attempt; 3.Meeting the criteria of substance use disorder according to DSM-5 during the past 6 months; 4.History of adjunctive treatment with antidepressants and/or antipsychotics (allowing a combination of small doses of benzodiazepines); 5.Having used anticoagulants (heparin, warfarin, etc.), glucocorticoids or medications for thyroid diseases in the past 3 months; 6.Abnormal urine toxicology or thyroid screening results; 7.History of seizures or family history of epilepsy; 8.History of antidepressant treatment other than medication within the past six months (i.e. ECT, rTMS, psychotherapy); 9.Pregnant or breast breeding women; 10.Color-blindness 11.Transaminase (ALT and AST) showed in liver function tests 2 times above the upper limit of the normal range; 12.Electrocardiogram examination of QTc ≥ 430 ms in male, QTc ≥ 450 ms in female.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University	Changsha	Hunan	China	410001

Sponsors and Collaborators

Central South University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lingjiang Li, President of Chinese Psychiatry Society of Chinese Medical Association, Central South University

ClinicalTrials.gov Identifier:

NCT04589143

Other Study ID Numbers:

Second Xiangya hospital

First Posted:

Oct 19, 2020

Last Update Posted:

Oct 19, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Lingjiang Li, President of Chinese Psychiatry Society of Chinese Medical Association, Central South University

adjunctive agomelatine

antidepressant therapy

major depressive disorder

Additional relevant MeSH terms:

Depressive Disorder

S 20098

Study Results

No Results Posted as of Oct 19, 2020