the Efficacy and Safety of Agomelatine in the Patients With Parkinson's Disease
NCT ID: NCT03977441
Last Updated: 2019-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
240 participants
INTERVENTIONAL
2019-07-31
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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control group
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
Agomelatine or PIacebo
control group:Pramipexole+pIacebo experimental group:Pramipexole+Agomelatine
experimental group
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
Agomelatine or PIacebo
control group:Pramipexole+pIacebo experimental group:Pramipexole+Agomelatine
Interventions
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Agomelatine or PIacebo
control group:Pramipexole+pIacebo experimental group:Pramipexole+Agomelatine
Other Intervention Names
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Eligibility Criteria
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Inclusion 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 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
30 Years
75 Years
ALL
No
Sponsors
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Second Affiliated Hospital of Soochow University
OTHER
Responsible Party
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Chun-Feng Liu
Professor
Principal Investigators
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Chun-Feng Liu, MD
Role: PRINCIPAL_INVESTIGATOR
Second Affiliated Hospital of Soochow University
Central Contacts
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References
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Fasano A, Daniele A, Albanese A. Treatment of motor and non-motor features of Parkinson's disease with deep brain stimulation. Lancet Neurol. 2012 May;11(5):429-42. doi: 10.1016/S1474-4422(12)70049-2.
Reijnders JS, Ehrt U, Weber WE, Aarsland D, Leentjens AF. A systematic review of prevalence studies of depression in Parkinson's disease. Mov Disord. 2008 Jan 30;23(2):183-9; quiz 313. doi: 10.1002/mds.21803.
Chaudhuri KR, Healy DG, Schapira AH; National Institute for Clinical Excellence. Non-motor symptoms of Parkinson's disease: diagnosis and management. Lancet Neurol. 2006 Mar;5(3):235-45. doi: 10.1016/S1474-4422(06)70373-8.
Chaudhuri KR, Schapira AH. Non-motor symptoms of Parkinson's disease: dopaminergic pathophysiology and treatment. Lancet Neurol. 2009 May;8(5):464-74. doi: 10.1016/S1474-4422(09)70068-7.
Yong MH, Fook-Chong S, Pavanni R, Lim LL, Tan EK. Case control polysomnographic studies of sleep disorders in Parkinson's disease. PLoS One. 2011;6(7):e22511. doi: 10.1371/journal.pone.0022511. Epub 2011 Jul 22.
Zesiewicz TA, Sullivan KL, Arnulf I, Chaudhuri KR, Morgan JC, Gronseth GS, Miyasaki J, Iverson DJ, Weiner WJ; Quality Standards Subcommittee of the American Academy of Neurology. Practice Parameter: treatment of nonmotor symptoms of Parkinson disease [RETIRED]: report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2010 Mar 16;74(11):924-31. doi: 10.1212/WNL.0b013e3181d55f24.
Ashton AK, Jamerson BD, L Weinstein W, Wagoner C. Antidepressant-related adverse effects impacting treatment compliance: Results of a patient survey. Curr Ther Res Clin Exp. 2005 Mar;66(2):96-106. doi: 10.1016/j.curtheres.2005.04.006.
Lam RW. Addressing circadian rhythm disturbances in depressed patients. J Psychopharmacol. 2008 Sep;22(7 Suppl):13-8. doi: 10.1177/0269881108092591.
Hogl B, Arnulf I, Comella C, Ferreira J, Iranzo A, Tilley B, Trenkwalder C, Poewe W, Rascol O, Sampaio C, Stebbins GT, Schrag A, Goetz CG. Scales to assess sleep impairment in Parkinson's disease: critique and recommendations. Mov Disord. 2010 Dec 15;25(16):2704-16. doi: 10.1002/mds.23190.
Ensrud KE, Joffe H, Guthrie KA, Larson JC, Reed SD, Newton KM, Sternfeld B, Lacroix AZ, Landis CA, Woods NF, Freeman EW. Effect of escitalopram on insomnia symptoms and subjective sleep quality in healthy perimenopausal and postmenopausal women with hot flashes: a randomized controlled trial. Menopause. 2012 Aug;19(8):848-55. doi: 10.1097/gme.0b013e3182476099.
Schrag A, Barone P, Brown RG, Leentjens AF, McDonald WM, Starkstein S, Weintraub D, Poewe W, Rascol O, Sampaio C, Stebbins GT, Goetz CG. Depression rating scales in Parkinson's disease: critique and recommendations. Mov Disord. 2007 Jun 15;22(8):1077-92. doi: 10.1002/mds.21333.
Leentjens AF, Verhey FR, Luijckx GJ, Troost J. The validity of the Beck Depression Inventory as a screening and diagnostic instrument for depression in patients with Parkinson's disease. Mov Disord. 2000 Nov;15(6):1221-4. doi: 10.1002/1531-8257(200011)15:63.0.co;2-h.
Richard IH, McDermott MP, Kurlan R, Lyness JM, Como PG, Pearson N, Factor SA, Juncos J, Serrano Ramos C, Brodsky M, Manning C, Marsh L, Shulman L, Fernandez HH, Black KJ, Panisset M, Christine CW, Jiang W, Singer C, Horn S, Pfeiffer R, Rottenberg D, Slevin J, Elmer L, Press D, Hyson HC, McDonald W; SAD-PD Study Group. A randomized, double-blind, placebo-controlled trial of antidepressants in Parkinson disease. Neurology. 2012 Apr 17;78(16):1229-36. doi: 10.1212/WNL.0b013e3182516244. Epub 2012 Apr 11.
Barone P, Poewe W, Albrecht S, Debieuvre C, Massey D, Rascol O, Tolosa E, Weintraub D. Pramipexole for the treatment of depressive symptoms in patients with Parkinson's disease: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2010 Jun;9(6):573-80. doi: 10.1016/S1474-4422(10)70106-X. Epub 2010 May 7.
San L, Arranz B. Agomelatine: a novel mechanism of antidepressant action involving the melatonergic and the serotonergic system. Eur Psychiatry. 2008 Sep;23(6):396-402. doi: 10.1016/j.eurpsy.2008.04.002. Epub 2008 Jun 25.
Rivara S, Mor M, Bedini A, Spadoni G, Tarzia G. Melatonin receptor agonists: SAR and applications to the treatment of sleep-wake disorders. Curr Top Med Chem. 2008;8(11):954-68. doi: 10.2174/156802608784936719.
Lemoine P, Guilleminault C, Alvarez E. Improvement in subjective sleep in major depressive disorder with a novel antidepressant, agomelatine: randomized, double-blind comparison with venlafaxine. J Clin Psychiatry. 2007 Nov;68(11):1723-32. doi: 10.4088/jcp.v68n1112.
Other Identifiers
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JD-LK-2019-008-02
Identifier Type: -
Identifier Source: org_study_id
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