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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015559
Receipt No. 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

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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
Email 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
Email ta@kuhp.kyoto-u.ac.jp

Sponsor
Institute Osaka Redcross Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016052

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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