Unique ID issued by UMIN | UMIN000016734 |
---|---|
Receipt number | R000019402 |
Scientific Title | The evaluation of duloxetine effect for the parkinsonism and gait freezing |
Date of disclosure of the study information | 2015/04/01 |
Last modified on | 2017/12/22 17:13:40 |
The evaluation of duloxetine effect for the parkinsonism and gait freezing
The evaluation of effect of duloxetine and parkinsonism
The evaluation of duloxetine effect for the parkinsonism and gait freezing
The evaluation of effect of duloxetine and parkinsonism
Japan |
Parkinson's disease
Neurology |
Others
NO
We will aim to evaluate the efficacy of parkinsonism and gait freezing among the patients with PD. Additionally, we will evaluate the status of depression or degree of pain befor and after treatmens of dloxetine. We select the doublet-blind study.
Efficacy
FOG-Q:freezing of gait questionnair
UPDRS:Unified Parkinson's Disease Rating Scale
H & Y; Hoehn and Yahr stage
HDR-S:Hamilton Depression Rating Scale
Beck Score
QIDS-J; Quick Inventory of Depressive Symptomatology
HDS-R; revised Hasegawa's dementia scale
MMSE; Mini-mental scale examination
VAS; Visual Analog Scale
FRS; Face rating scale
WPI; Widespread pain index; from Fibromyalgia diagnostic criteria, ACR2010
Interventional
Single arm
Randomized
Double blind -all involved are blinded
Placebo
1
Treatment
Medicine |
Drug ; Duloxetine
Duraion; SEP012014-AUG312016
Doseage; 20mg/day or 40mg/day
Times; one time per day P.O.
20 | years-old | <= |
85 | years-old | >= |
Male and Female
The patients are enrolled, who diagnosed clinically Parkinson's disease, complicated with depressive states, freezing gait, or chronic pain.
The patinets adopted exclusion criteria
1, succidal tendency, severe depression.
2, Severe renal or liver dysfunction
3, hypoersensitivity for duloxetine.
4, Taking MAO-B inhibitor
5, complicated cognitive decline; MMSE under 23.
6, Schisophrenia or bipolar disorder
7, Personality disorders
8, eleavated ESR or CRP in blood examination.
9, ANA over 320 times, or Rheumatoid factor over 100 IU/ml.
10, comorbidity of epilepsy or seizure
11, dysuremia, galucoma.
12, alchol abuser
13, attending dcotor judge not to iclude this protocol.
30
1st name | |
Middle name | |
Last name | Kenya Nishioka |
Department of Neurology, Juntendo University School of Medicine
Department of Neurology
3-1-1 Hongo Bunkyo-ku, Tokyo, Japan
03-3813-3111
kenya.nishioka@gmail.com
1st name | |
Middle name | |
Last name | Kenya Nishioka |
Department of Neurology, Juntendo University School of Medicine
Department of Neurology
3-1-1 Hongo Bunkyo-ku, Tokyo, Japan
03-3813-3111
kenya.nishioka@gmail.com
Department of Neurology, Juntendo University School of Medicine
Department of Neurology, Juntendo University School of Medicine
Self funding
NO
2015 | Year | 04 | Month | 01 | Day |
Unpublished
Completed
2014 | Year | 09 | Month | 01 | Day |
2015 | Year | 04 | Month | 01 | Day |
2015 | Year | 03 | Month | 08 | Day |
2017 | Year | 12 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019402