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Safety Evaluation of Agomelatine Use in Children and Adolescents

Safety Evaluation of Agomelatine Use in Children and Adolescents

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500105286
Enrollment
Unknown
Registered
2025-07-01
Start date
2025-07-14
Completion date
Unknown
Last updated
2025-07-07

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

Conditions

Adolescent Depression

Interventions

Agomelatine group:None
Other antidepressant group:None

Sponsors

West China Hospital of Shichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: Age = 7 or Hamilton Depression Rating Scale (HAMD) score >= 7; complete medical records available (with at least one follow-up assessment within one month after medication initiation).

Exclusion criteria

Exclusion criteria: Any clinically significant abnormality detected during physical examination, ECG, liver ultrasound, or laboratory tests that may interfere with the implementation or evaluation of this study; known history of alcohol or drug abuse or dependence; meeting diagnostic criteria for any psychiatric disorder other than depressive disorder, or having severe or uncontrolled medical conditions; incomplete medical records; prior use of other antidepressants; concurrent electroconvulsive therapy (ECT) during treatment with the aforementioned antidepressants; concomitant use of two or more antidepressants; female subjects who are pregnant or breastfeeding.

Design outcomes

Primary

MeasureTime frame
Clinical Response Rate in Depression;Clinical Remission Rate in Depression;

Secondary

MeasureTime frame
Rehospitalization rate;Liver Function Tests;Complete Blood Count;Prolonged QTc Interval;Arrhythmia Incidence Rate;

Countries

China

Contacts

Public ContactLi Yin

West China Hospital of Shichuan University

yli009@163.com+86 189 8060 6720

Outcome results

None listed

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