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Efficacy and safety of agomelatine combined with SSRIs in depressive disorder: a randomized controlled trial

Efficacy and safety of agomelatine combined with SSRIs in depressive disorder: a randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032518
Enrollment
Unknown
Registered
2020-05-01
Start date
2020-05-01
Completion date
Unknown
Last updated
2020-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Interventions

SSRIs-treated group:Treat with the combination of SSRIs (sertraline or escitalopram) in the first 6 weeks.Those whose efficacy is well in the first stage of treatment will continue to receive the orig
Agomelatine-treated group:Treat with Agomelatine in the first 6 weeks.Those whose efficacy is well in the first stage of treatment will continue to receive the original drug and the same dose.Others w

Sponsors

Shandong Mental Health Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Meet the diagnostic criteria for DSM-5 'major depressive disorder' ; 2.Patients with first episode of major depressive disorder who have not received any treatment, or have not received any treatment in the last 2 months; 3.Aged of first onset >= 25 years; 4.Han nationality, 25-60 years old, regardless of gender; 5.Hamilton Depression Scale (HAMD-17) >=17, Hypomania Check List(HCL-32) <13; 6.Junior high school or above; 7.Participate in this study voluntarily and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1.A history of serious physical diseases, organic brain diseases and craniocerebral trauma; 2.Patients with severe mental retardation; 3.Hepatitis B virus carriers / patients, Hepatitis C virus carriers / patients, or those with transaminase exceeding the normal upper limit; 4.Patients who abuse drugs, alcohol or other psychoactive substances; 5.Persons known to be allergic to the ingredients of research drugs; 6.Family history of bipolar disorder; 7.Those who are currently in the perinatal period or have a pregnancy plan.

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Scale;

Secondary

MeasureTime frame
Hamilton Anxiety Scale;Snaith-Hamilton Pleasure Scale;Thinc-it;Hypomania Check List;

Countries

China

Contacts

Public ContactGuanglei Xun

Shandong Mental Health Center

xungl@163.com+86 15069053599

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026