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Agomelatine Augmentation Added to SSRIs or SNRIs for Depression

Primary Purpose

MDD

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Agomelatine
Placebos
Sponsored by
Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for MDD focused on measuring adjunctive agomelatine, antidepressant therapy, major depressive disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experience group

Contral group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Response rate
The ratio of patients who achieved percentage improvement of HAMD17 score ≥50%
Remission rate
The ratio of patients who achieved HAMD17 score ≤ 7 points

Secondary Outcome Measures

Full Information

First Posted
October 9, 2020
Last Updated
October 9, 2020
Sponsor
Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT04589143
Brief Title
Agomelatine Augmentation Added to SSRIs or SNRIs for Depression
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MDD
Keywords
adjunctive agomelatine, antidepressant therapy, major depressive disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experience group
Arm Type
Experimental
Arm Description
In this group,participants take agomelatine at a dose of 25-50 mg/d for 8 weeks.
Arm Title
Contral group
Arm Type
Placebo Comparator
Arm Description
In this group,participants take a placebo at a dose of 25-50 mg/d for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Agomelatine
Intervention Description
Oral tablets of agomelatine at a dose of 25-50 mg/d for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Oral tablets of placebos at a dose of 25-50 mg/d for 8 weeks
Primary Outcome Measure Information:
Title
Response rate
Description
The ratio of patients who achieved percentage improvement of HAMD17 score ≥50%
Time Frame
at baseline and in 2, 4 and 8 week
Title
Remission rate
Description
The ratio of patients who achieved HAMD17 score ≤ 7 points
Time Frame
at baseline and in 2, 4 and 8 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lingjiang Li, MD Ph.D
Phone
+86 13807314575
Email
LLJ2920@csu.edu.cn
Facility Information:
Facility Name
Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lingjiang Li, MD Ph.D
Phone
+86 13807314575
Email
LLJ2920@csu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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Agomelatine Augmentation Added to SSRIs or SNRIs for Depression

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