UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparative study between SSRI and SNRI treatment on depressive patients with Parkinson diseases
Title of the study (Brief title)	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	Makio Takahashi
Organization	Osaka Redcross Hospital
Division name	Neurology
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	Makio Takahashi
Organization	Osaka Redcross Hospital, Japan Redcross
Division name	Neurology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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