Major Depressive DisorderPhase 4NCT04589143
A Double-blind, Placebo-controlled Study of Antidepressant Augmentation With Agomelatine
A Phase 4 study testing Agomelatine in people with Major Depressive Disorder, run by Central South University at 1 site in China.
Trial summary
The purpose of this study was to investigate the efficacy and safety of antidepressant augmentation with agomelatine in the treatment of patients with depression who did not demonstrate satisfying response to selective serotonin reuptake inhibitor (SSRI) and serotonin-noradrenaline reuptake inhibitor (SNRI) during… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Agomelatine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 137 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 30 Jan 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Meeting criteria for other psychiatric disorders according to DSM-IV (except generalized anxiety disorder), such as schizophrenia, bipolar disorder, or mental disorders related to alcohol and drug dependence.
- Current or previous history of brain organic diseases or loss of consciousness for more than 5 minutes.
- Current or previous history of major physical diseases (including rheumatic immune system diseases, endocrine and metabolic diseases, nervous system diseases, etc.).
- Current serious suicidal ideation or suicide attempt.
- Pregnancy or lactation in women.
- Color blindness (which would hinder neurocognitive testing).
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- Use of anticoagulants (e.g., heparin, warfarin), glucocorticoids, or treatment for thyroid diseases in the past 3 months.
- Having received any neurocognitive assessment similar to this study in the past 12 months.
- Positive urine drug screening results or abnormal thyroid function test.
- Liver function tests showing transaminase (ALT and AST) levels 2 times above the upper limit of the normal range.
- Electrocardiogram examination revealing a QTc ≥ 430 ms in males or QTc ≥ 450 ms in females.
Trial locations and contacts
1 site in 1 country.
China1 site
Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University
Changsha, Hunan, 410001
About this study
Official title: Agomelatine Augmentation in Early-Nonresponsive Patients With Major Depressive Disorder Receiving SSRIs or SNRIs: a Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
The purpose of this study was to investigate the efficacy and safety of antidepressant augmentation with agomelatine in the treatment of patients with depression who did not demonstrate satisfying response to selective serotonin reuptake inhibitor (SSRI) and serotonin-noradrenaline reuptake inhibitor (SNRI) during their early phase of treatment; this study also aims to explore the effects of augmenting antidepressant treatment with agomelatine on various aspects, including sleep quality, quality of life, social functioning, and cognitive function in patients with MDD.
- Conditions
- Major Depressive Disorder
- Being tested
- Agomelatine, Placebos
- Keywords
- agomelatine, antidepressant, augmentation, major depressive disorder, early-nonresponsive
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AgomelatineDrug
Oral tablets of agomelatine at a dose of 25-50 mg/d for 8 weeks
PlacebosDrug
Oral tablets of placebos at a dose of 25-50 mg/d for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experience group | Experimental | In this group,participants take agomelatine at a dose of 25-50 mg/d for 8 weeks. Receives: Drug: Agomelatine |
| Contral group | Placebo comparator | In this group,participants take a placebo at a dose of 25-50 mg/d for 8 weeks. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Scale scores
Depression severity; higher scores mean a worse outcome.
Measured: Baseline (week 0), week 2, week 4, week 8
Side Effect Rating Scale (SERS) scores
Safety: frequency and severity of adverse events; higher scores mean a better outcome.
Measured: Baseline (week 0), week 2, week 4, week 8
Secondary outcomes (9)
Patient Health Questionnaire (PHQ-9) scores
Self-report depression severity; higher scores mean a worse outcome.
Measured: Baseline (week 0), week 2, week 4, week 8
Hamilton Anxiety Rating Scale (HAMA) scores
Anxiety severity; higher scores mean a worse outcome.
Measured: Baseline (week 0), week 2, week 4, week 8
General Anxiety Disorder-7 (GAD-7) scores
Self-report anxiety severity; higher scores mean a worse outcome.
Measured: Baseline (week 0), week 2, week 4, week 8
Changes in Clinical Global Impression (CGI) scores
Symptom severity; higher scores mean a worse outcome.
Measured: Baseline (week 0), week 2, week 4, week 8
Snaith-Hamilton Pleasure Scale (SHAPS) scores
Self-reported severity of anhedonia; higher scores mean a worse outcome.
Measured: Baseline (week 0), week 2, week 4, week 8
Sheehan Disability Scale (SDS) scores
Self-report tool that assesses functional impairment in work/school, social life, and family life; higher scores mean a worse outcome.
Measured: Baseline (week 0), week 2, week 4, week 8
Quality of life (EQ-5D-3L) scores
Self-report Quality of life; higher scores mean a better outcome.
Measured: Baseline (week 0), week 2, week 4, week 8
performance of Neurocognitive test, including executive function, attention, processing speed, and memory
Neurocognitive function; higher scores mean a better outcome.
Measured: Baseline (week 0), week 2, week 4, week 8
Athens Insomnia Scale (AIS) scores
Self-report severity of insomnia; higher scores mean a worse outcome.
Measured: Baseline (week 0), week 2, week 4, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Oct 2020
- Primary completion30 Dec 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lingjiang Li, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589143
- Sponsor's protocol ID
- Second Xiangya hospital
- Status last verified
- Mar 2024
- First submitted
- 9 Oct 2020
- Last updated
- 1 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ju Y, Ou W, Chen H, Yang L, Long Y, Liang H, Xi Z, Huang M, Chen W, Lv G, Shao F, Liu B, Liu J, Li Z, Liao M, Liang W, Yao Z, Zhang Y, Li L. Agomelatine as adjunctive therapy with SSRIs or SNRIs for major depressive disorder: a multicentre, double-blind, randomized, placebo-controlled trial. BMC Med. 2025 Mar 5;23(1):137. doi: 10.1186/s12916-025-03951-0.
PubMed 40038707
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Agomelatine Augmentation in Early-Nonresponsive Patients With Major Depressive Disorder Receiving SSRIs or SNRIs: a Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04589143
- Acronym / sponsor ID
- Second Xiangya hospital
- Conditions
- Major Depressive Disorder
- Keywords
- agomelatine, antidepressant, augmentation, major depressive disorder, early-nonresponsive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to investigate the efficacy and safety of antidepressant augmentation with agomelatine in the treatment of patients with depression who did not demonstrate satisfying response to selective serotonin reuptake inhibitor (SSRI) and serotonin-noradrenaline reuptake inhibitor (SNRI) during their early phase of treatment; this study also aims to explore the effects of augmenting antidepressant treatment with agomelatine on various aspects, including sleep quality, quality of life, social functioning, and cognitive function in patients with MDD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Experience group | Experimental | Drug: AgomelatineIn this group,participants take agomelatine at a dose of 25-50 mg/d for 8 weeks. |
| Contral group | Placebo comparator | Drug: PlacebosIn this group,participants take a placebo at a dose of 25-50 mg/d for 8 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- Meeting criteria for other psychiatric disorders according to DSM-IV (except generalized anxiety disorder), such as schizophrenia, bipolar disorder, or mental disorders related to alcohol and drug dependence.
- Current or previous history of brain organic diseases or loss of consciousness for more than 5 minutes.
- Current or previous history of major physical diseases (including rheumatic immune system diseases, endocrine and metabolic diseases, nervous system diseases, etc.).
- Current serious suicidal ideation or suicide attempt.
- Pregnancy or lactation in women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AgomelatineOral tablets of agomelatine at a dose of 25-50 mg/d for 8 weeks | Drug | Experience group |
| PlacebosOral tablets of placebos at a dose of 25-50 mg/d for 8 weeks | Drug | Contral group |
Primary outcome
Hamilton Depression Scale scores
Time frame: Baseline (week 0), week 2, week 4, week 8
Depression severity; higher scores mean a worse outcome.
Side Effect Rating Scale (SERS) scores
Time frame: Baseline (week 0), week 2, week 4, week 8
Safety: frequency and severity of adverse events; higher scores mean a better outcome.
9 secondary outcomes
Patient Health Questionnaire (PHQ-9) scores
Time frame: Baseline (week 0), week 2, week 4, week 8
Hamilton Anxiety Rating Scale (HAMA) scores
Time frame: Baseline (week 0), week 2, week 4, week 8
General Anxiety Disorder-7 (GAD-7) scores
Time frame: Baseline (week 0), week 2, week 4, week 8
Changes in Clinical Global Impression (CGI) scores
Time frame: Baseline (week 0), week 2, week 4, week 8
Snaith-Hamilton Pleasure Scale (SHAPS) scores
Time frame: Baseline (week 0), week 2, week 4, week 8
Sheehan Disability Scale (SDS) scores
Time frame: Baseline (week 0), week 2, week 4, week 8
Quality of life (EQ-5D-3L) scores
Time frame: Baseline (week 0), week 2, week 4, week 8
performance of Neurocognitive test, including executive function, attention, processing speed, and memory
Time frame: Baseline (week 0), week 2, week 4, week 8
Athens Insomnia Scale (AIS) scores
Time frame: Baseline (week 0), week 2, week 4, week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Derived from this study: PubMed 40038707Ju Y, Ou W, Chen H, Yang L, Long Y, Liang H, Xi Z, Huang M, Chen W, Lv G, Shao F, Liu B, Liu J, Li Z, Liao M, Liang W, Yao Z, Zhang Y, Li L. Agomelatine as adjunctive therapy with SSRIs or SNRIs for major depressive disorder: a multicentre, double-blind, randomized, placebo-controlled trial. BMC Med. 2025 Mar 5;23(1):137. doi: 10.1186/s12916-025-03951-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Agomelatine in people with Major Depressive Disorder, run by Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Scale scores (time frame: Baseline (week 0), week 2, week 4, week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04589143, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024.