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

NCT03977441 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2019-06-06

No results posted yet for this study

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

DRUG

Agomelatine or PIacebo

control group:Pramipexole+pIacebo experimental group:Pramipexole+Agomelatine

Sponsors & Collaborators

  • Second Affiliated Hospital of Soochow University

    lead OTHER

Principal Investigators

  • Chun-Feng Liu, MD · Second Affiliated Hospital of Soochow University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-31
Primary Completion
2020-12-31
Completion
2020-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03977441 on ClinicalTrials.gov