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Efficacy and Safety of Agomelatine in Epilepsy Patients With Inpaired Sleep and Mood Disorders: an Observational,Open,and Retrospective study

Observational Study on the Clinical Efficacy of Avamelatin in Patients with Epilepsy Complicated with Emotional and Sleep Disorders

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300075165
Enrollment
Unknown
Registered
2023-08-28
Start date
2023-08-28
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

Epilepsy Patients With Inpaired Sleep and Mood Disorders

Interventions

Agomelatine group:NA

Sponsors

Department of Neurology, Shandong Provincial Hospital Affiliated to Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Be diagnosed as epilepsy by the International Anti-Epilepsy Alliance (ILAE) in 2017.The age ranges from 18 to 65. There was at least one satisfaction of Hamilton anxiety scale (HAMA) = 7, Hamilton Depression scale (HAMD) = 7 or Pittsburgh Sleep quality Index (PSQI) = 6 before treatment. Patients must be treated with agomelatine or escitalopram for 8 weeks or more. No adjustment was made before the use of agomelatine or escitalopram in patients with epilepsy.

Exclusion criteria

Exclusion criteria: 1. Hepatitis B virus carriers / patients, hepatitis C virus carriers / patients, patients with liver function damage or patients with elevated transaminase above the normal limit; 2. Known history of alcohol or drug addiction or abuse; 3. Patients with primary diseases of anxiety, depression or sleep disorders have been treated with other drugs or non-drug regimens; 4. Adjustment of antiepileptic drugs during the treatment of agomelastine or escitalopram; 5. Those who can not be revisited regularly; 6. History of drug allergy.

Design outcomes

Primary

MeasureTime frame
Hamilton Anxiety Scale, HAMA;Hamilton Depression Scale Score, HAMD;Pittsburgh Sleep Quality Index, PSQI;Adverse events;

Secondary

MeasureTime frame
Seizure frequency;

Countries

China

Contacts

Public ContactXuewu Liu

Department of Neurology, Shandong Provincial Hospital Affiliated to Shandong First Medical University

snlxw1966@163.com+86 137 9112 2679

Outcome results

None listed

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