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

Soochow University

Status and phase: Unknown; Phase 4

Conditions: Sleep Disorders; Parkinson Disease; Circadian Rhythm Disorders; Depression

Treatments: Drug: Agomelatine or PIacebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03977441

JD-LK-2019-008-02

Details and patient eligibility

About

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

Enrollment: 240 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 2 patient groups, including a placebo group

control group

Placebo Comparator group

Description:

treated with Pramipexole 0.75mg/d（0.25mg tid)+placebo 25mg qn \*2weeks than Pramipexole 0.75mg/d（0.25mg tid)+placebo 50mg qn \* 10 weeks

Treatment:

Drug: Agomelatine or PIacebo

experimental group

Experimental group

Description:

treated with Pramipexole 0.75mg/d（0.25mg tid)+Agomelatine25 mg qn \*2weeks than Pramipexole 0.75mg/d（0.25mg tid)+Agomelatine 50mg qn \* 10weeks

Treatment:

Drug: Agomelatine or PIacebo