NCT03977441

the Efficacy and Safety of Agomelatine in the Patients With Parkinson's Disease

A Multicenter, Randomized, Double-blind, Placebo-controlled Study: Evaluation of the Efficacy and Safety of Agomelatine in the Treatment of Sleep Disorders and Depression in Patients With Parkinson's Disease

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Second Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Among the patients with Parkinson's disease, about 40%\~50% will suffer from depression, 40% will suffer from anxiety, and 40%\~60% will suffer from sleep disorder. These non-motor symptoms of Parkinson's disease will cause great physical and psychological pain and affect the quality of life seriously. Commonly used therapeutic drugs, such as selective serotonin reuptake inhibitor (SSRI) and clonazepam, can cause a variety of side effects, including serotonin syndrome, sexual dysfunction, daytime fatigue, insomnia, residual effects and increased risk of falls. Therefore, a new and more reasonable therapeutic choice should be sought. Agomelatine is a new type of antidepressant with novel mechanism, and can improve sleep structure and circadian rhythm. The aim of this multi-center randomized controlled trial (RCT) is to clarify the role of agomelatine in improving sleep disorders and depression in patients with Parkinson's disease

Conditions

• Parkinson Disease
• Depression
• Sleep Disorders
• Circadian Rhythm Disorders

Interventions

Type	Name	Description
DRUG	Agomelatine or PIacebo	control group:Pramipexole+pIacebo experimental group:Pramipexole+Agomelatine

Timeline

• Start date: 2019-07-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2019-06-06
• Last updated: 2019-06-06