Clinical trial NCT03977441: the Efficacy and Safety of Agomelatine in the Patients With Parkinson's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Parkinson Disease
Depression
Sleep Disorders
Circadian Rhythm Disorders
Lead sponsor: Second Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 240
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: treatment group: treated with agomelatine control group: treated with placebo
Primary purpose: TREATMENT

Brief 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


Eligibility 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

Primary outcomes:
measure: The efficacy of the treatment on the sleep disorders in Parkinson's disease evaluated by PSQI scale score change
timeFrame: visit1(baseline),visit2(2ed week),visit3(6th week),visit4(12th week)
Secondary outcomes:
measure: The efficacy of the treatment on the sleep disorders in Parkinson's disease evaluated by PDSS, sleep diary and activity trackers
timeFrame: PDSS:visit1(baseline),visit2(2ed week),visit3(6th week),visit4(12th week); Sleep diary and activity trackers: 12 weeks, through study completion.
measure: The efficacy on the excessive daytime sleepiness of patients with Parkinson's disease
timeFrame: visit1(baseline),visit2(2ed week),visit3(6th week),visit4(12th week)
measure: The efficacy on the fatigue of patients with Parkinson's disease
timeFrame: visit1(baseline),visit2(2ed week),visit3(6th week),visit4(12th week)
measure: The efficacy on the circadian rhythm of patients with Parkinson's disease
timeFrame: visit1(baseline),visit3(6th week),visit4(12th week)
measure: The efficacy on the rapid eye movement sleep behavior disorder (RBD) of patients with Parkinson's disease
timeFrame: visit1(baseline),visit2(2ed week),visit3(6th week),visit4(12th week)
measure: The efficacy on the depression of patients with Parkinson's disease
timeFrame: visit1(baseline),visit3(6th week),visit4(12th week)
measure: The efficacy on the anxiety of patients with Parkinson's disease
timeFrame: visit1(baseline),visit3(6th week),visit4(12th week)
measure: The efficacy on the movement of patients with Parkinson's disease
timeFrame: visit1(baseline),visit3(6th week),visit4(12th week)
measure: The efficacy on the life quality of patients with Parkinson's disease
timeFrame: visit1(baseline),visit3(6th week),visit4(12th week)
measure: Dosage and frequency of sedative and hypnotic drugs
timeFrame: visit1(baseline),visit2(2ed week),visit3(6th week),visit4(12th week)
measure: The Safety of Agomelatine in the Patients With Parkinson's Disease - the effect on the total number of red blood cells.
timeFrame: visit1(baseline),visit2(2ed week),visit3(6th week),visit4(12th week)
measure: The Safety of Agomelatine in the Patients With Parkinson's Disease - the effect on the total number of white blood cells.
timeFrame: visit1(baseline),visit2(2ed week),visit3(6th week),visit4(12th week)
measure: The Safety of Agomelatine in the Patients With Parkinson's Disease - the effect on the platelet count.
timeFrame: visit1(baseline),visit2(2ed week),visit3(6th week),visit4(12th week)
measure: The Safety of Agomelatine in the Patients With Parkinson's Disease - the effect on the concentration of the hemoglobin.
timeFrame: visit1(baseline),visit2(2ed week),visit3(6th week),visit4(12th week)
measure: The Safety of Agomelatine in the Patients With Parkinson's Disease - the effect on the liver function
timeFrame: visit1(baseline),visit2(2ed week),visit3(6th week),visit4(12th week)
measure: The Safety of Agomelatine in the Patients With Parkinson's Disease - the effect on the renal function
timeFrame: visit1(baseline),visit2(2ed week),visit3(6th week),visit4(12th week)
measure: Adverse Event and Serious Adverse Event
timeFrame: visit1(baseline),visit2(2ed week),visit3(6th week),visit4(12th week)
Other outcomes:
Locations:
Study officials:
affiliation: Second Affiliated Hospital of Soochow University
name: Chun-Feng Liu, MD
role: PRINCIPAL_INVESTIGATOR
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