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

NCT03977441 Phase 4 UNKNOWN

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

Details

Lead sponsor	Second Affiliated Hospital of Soochow University
Phase	Phase 4
Status	UNKNOWN
Enrolment	240
Start date	2019-07
Completion	2020-12

Conditions

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

Interventions

• Agomelatine or PIacebo

Primary outcomes

• The efficacy of the treatment on the sleep disorders in Parkinson's disease evaluated by PSQI scale score change — visit1(baseline),visit2(2ed week),visit3(6th week),visit4(12th week)
  The Pittsburgh sleep quality index (PSQI) is a widely used sleep evaluation scale in the Chinese population. The sensitivity and specificity of the PSQI (cut-off at 7) are 98.3% and 90.2%, respectively. PSQI has been used to evaluate the sleep disorders in patients with Parkinson's disease focusing on their sleep habits primarily.