A multicenter, randomized, double-blind, placebo-controlled trial of the efficacy and safety of agomelatine in patients with rapid eye movement (REM) sleep behavior disorder (RBD)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100048875

Enrollment

Unknown

Registered

2021-07-19

Start date

2021-07-19

Completion date

Unknown

Last updated

2022-03-28

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

Conditions

Rapid eye movement (REM) sleep behavior disorder (RBD)

Interventions

Experimental group:Agomelatine 25mg/d, oral treatment before sleep, the dose was increased to 50mg/d after 2 weeks of treatment if no liver impairment occurs

Control group:Placebo, oral treatment before sleep

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged from 18 to 65 years; 2. Diagnosed as RBD patients in accordance with the International Classification of Sleep Disorders (Third Edition) published by AASM; 3. RBDQ-HK score; 4. RWA was confirmed by PSG detection; 5. The patient is in generally good condition and can receive drug therapy and long-term follow-up; 6. Willingness to participate in the study and are able to sign or have their legal representative to sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients diagnosed as secondary RBD; 2. A history of drug abuse or drug/alcohol dependence in the past year; 3. Patients suffering from serious underlying or somatic diseases or diseases that may affect the assessment (e.g., hearing or visual disorders); 4. Patients suffering from other serious neurodegenerative diseases; 5. Patients with positive hepatitis B virus (HBV) surface antigen, positive hepatitis C virus (HCV) antibody or serum aminotransferase (ALT) above the upper limit of normal value; 6. Allergic to agomelatine or its excipients; 7. Pregnant or lactating women, or women of childbearing age who take no contraceptive measures; 8. Currently participating in clinical trials of other drugs or medical devices; 9. Patients who are taking antipsychotics, or antidepressants other than agomelatine (including but not limited to SSRI and SNRI drugs); 10. The researchers did not consider it suitable for inclusion.

Design outcomes

Primary

Measure	Time frame
The alleviation rate of RWA detected by PSG ;	—

Secondary

Measure	Time frame
Changes of RBD-HK scale scores compared to baseline ;Changes of fatigue scale scores compared to baseline ;Changes of diurnal functional scale scores compared to baseline ;	—

Countries

China

Contacts

Public ContactLiu Jun

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

jly0520@hotmail.com+86 15221303819

Outcome results

None listed

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