UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015559 |
|---|---|
| Receipt number | R000016052 |
| Scientific Title | Comparative study between SSRI and SNRI treatment on depressive patients with Parkinson diseases |
| Date of disclosure of the study information | 2014/10/29 |
| Last modified on | 2018/12/14 09:58:00 |
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Basic information
Public title
Comparative study between SSRI and SNRI treatment on depressive patients with Parkinson diseases
Acronym
REBORN STUDY(CompaRativE study Between SSRI and SNRI treatment On depRessive patients with ParkinsoN diseases)
Scientific Title
Comparative study between SSRI and SNRI treatment on depressive patients with Parkinson diseases
Scientific Title:Acronym
REBORN STUDY(CompaRativE study Between SSRI and SNRI treatment On depRessive patients with ParkinsoN diseases)
Region
| Japan |
Condition
Condition
Parkinson's disease
Depression, Depressive state
Classification by specialty
| Neurology | Psychosomatic Internal Medicine | Geriatrics |
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main purpose of this comparative study is to clarify the effectiveness of SNRI versus SSRI for the treatment of depression and apathy in Parkinson's disease patients. The additional purpose is to find the benefit of these drugs for frozen gait . This study is expected to create the beneficial evidence for the selection of drugs in the treatment of depression/depressive state in many patients with Parkinson's disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The clinical symptoms is evaluated at 6weeks and 10weeks after the drug administration by the following modalities;
Primary outcomes
1. Quick Inventory of Depressive Symptomatology: QIDS-J
2. Apathy Score
Key secondary outcomes
Key secondary outcomes
1. Freezing of Gait Questionnaire:FOG-Q
2. Clinical Global Impression of Severity:CGI-S
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
paroxetine 20mg
Interventions/Control_2
Escitalopram 10mg
Interventions/Control_3
Duloxetine 40mg
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. The patient should be diagnosed with Parkinson's disease whose score of QIDS-J is 6 and more.
2. The agreement of the study from the applicant is needed.
3. The patient should be 40 years and more.
Key exclusion criteria
. have a history of drug already
. have a medication with MAO-B inhibitor within 2 weeks before entry.
. Taking the medication with Pimozide
. Prolonged QT syndrome
. severe liver dysfuncation
. severe renal dysfunction
. poorly controlled obstructive glaucoma
. have a history of suicide attempt
. Psychiatric disease needed for medication within 1 year
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makio Takahashi |
Organization
Osaka Redcross Hospital
Division name
Neurology
Zip code
Address
5-30, Fudegasaki-cho, Tennoji-Ku, Osaka, 543-8555, Japan
TEL
06-6774-5111
ta@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makio Takahashi |
Organization
Osaka Redcross Hospital, Japan Redcross
Division name
Neurology
Zip code
Address
5-30, Fudegasaki-cho, Tennoji-Ku, Osaka, 543-8555, Japan
TEL
06-6774-5111
Homepage URL
ta@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Osaka Redcross Hospital
Institute
Department
Personal name
Funding Source
Organization
Shionogi Pharmaceuticals Co.Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪赤十字病院、北野病院、済生会中津病院、関西電力病院、富永病院（いずれも大阪府）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 04 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 29 | Day |
Last modified on
| 2018 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016052
