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

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 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


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

Value
https://center6.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