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

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital of Soochow University
• Treatments: Pramipexole; S 20098

Criteria

Inclusion Criteria:

• diagnosed as Parkinson's disease conforming to 2015 International Movement Disorder Society(MDS) diagnostic criteria

• Hoehn-Yahr ≤ 3 at "open" stage

• Mini-mental State Examination(MMSE) ≥ 24 points;

• Pittsburgh Sleep Quality Index (PSQI) > 7 points;

• HAMD-17 > 13 points

• Pramipexole hydrochloride tablets 0.75mg / d (0.25mg tid) has been used stably for one month

• Signed informed consent

Exclusion Criteria:

• Parkinson's syndrome and Parkinsonism-Plus syndrome

• Parkinson's movement symptoms are still fluctuating or the treatment of Parkinson's movement symptoms is unstable

• Hepatitis B virus carriers/patients, hepatitis C virus carriers/patients, patients with impaired liver function or elevated transaminase levels above the upper limit

• Other serious neurological diseases, mental illnesses and physical illnesses

• History of alcohol and drugs dependence

• Dementia

• Combined treatment with CYP1A2 strong inhibitor (fluvoxamine, ciprofloxacin, rifampicin, amiodarone, mexiletine, atazanavir, etc.)

• High suicide risk or suicide attempt within 6 months (third item of HAMD-17 ≥ 3)

• Antidepressant medication or other psychiatric treatment in the past month

• pregnant or lactating

• intolerance or allergy to agomelatine active ingredients and excipients

• other conditions that are not suitable for the study considered by the investigators