Unique ID issued by UMIN | UMIN000038397 |
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Receipt number | R000043753 |
Scientific Title | An open-label single-arm study on efficacy and safety of dopamine replacement therapy for drug-induced parkinsonism |
Date of disclosure of the study information | 2019/10/28 |
Last modified on | 2023/04/30 10:23:23 |
A clinical study on efficacy and safety of dopamine replacement therapy for drug-induced parkinsonism
Dopamine replacement therapy for drug-induced parkinsonism
An open-label single-arm study on efficacy and safety of dopamine replacement therapy for drug-induced parkinsonism
An open-label single-arm study on efficacy and safety of dopamine replacement therapy for drug-induced parkinsonism
Japan |
Drug-induced parkinsonism
Neurology | Psychiatry |
Others
NO
To investigate the efficacy and safety of dopamine replacement therapy for drug-induced parkinsonism in patients with schizophrenia, bipolar disorder, or schizoaffective disorder.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Total score of Movement Disorder Society Unified Parkinson's Disease Rating Scale Part 3
Total score of Unified Dystonia Scale,
Total score of Abnormal Involuntary Movement Scale,
Total score of Mini-mental State Examination,
Total score of Montogomery-Aperg Depression Rating Scale,
Total score of Young Mania Rating Scale,
Total score of PANSS-6
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Levodopa/carbidopa 300-600mg/day for 2 weeks or more
20 | years-old | <= |
Not applicable |
Male and Female
1. Patients with schizophrenia, bipolar disorder, or schizoaffective disorder who receive antipsychotics and/or mood stabilizers.
2. Parkinsonism diagnosed by board-certified neurologists
1. Orthopedic conditions which preclude quantitative neurological assessments, such as fractures and severe arthralgia.
2. Severe intellectual disabilities which preclude accurate neurological assessments.
3. History of alcohol or other substance abuse.
4. Patients who are already diagnosed as having organic neurological diseases, or whose CT/MRI scans demonstrate cerebrovascular diseases (excluding a few to several numbers of small infarcts or microbleeds) or severe brain atrophy.
5. Patients who take levodopa or dopamine receptor agonists at the baseline assessment.
50
1st name | Yoshiyuki |
Middle name | |
Last name | Nishio |
Tokyo Metropolitan Matsuzawa Hospital
Department of Psychiatry and Neurology
156-0057
2-1-1 Kamikitazawa, Setagaya-ku, Tokyo
03-3303-7211
nishiokov@gmail.com
1st name | Yoshiyuki |
Middle name | |
Last name | Nishio |
Tokyo Metropolitan Matsuzawa Hospital
Department of Psychiatry and Neurology
156-0057
2-1-1 Kamikitazawa, Setagaya-ku, Tokyo
03-3303-7211
nishiokov@gmail.com
Tokyo Metropolitan Matsuzawa Hospital
Tokyo Metropolitan Government
Local Government
Tokyo Metropolitan Matsuzawa Hospital
2-1-1 Kamikitazawa, Setagaya-ku, Tokyo
03-3303-7211
nishiokov@gmail.com
NO
2019 | Year | 10 | Month | 28 | Day |
Unpublished
Open public recruiting
2019 | Year | 10 | Month | 19 | Day |
2019 | Year | 04 | Month | 19 | Day |
2019 | Year | 10 | Month | 20 | Day |
2022 | Year | 10 | Month | 31 | Day |
2022 | Year | 10 | Month | 31 | Day |
2023 | Year | 03 | Month | 31 | Day |
2023 | Year | 03 | Month | 31 | Day |
2019 | Year | 10 | Month | 27 | Day |
2023 | Year | 04 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043753
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