UMIN-CTR Clinical Trial

Public title

Multicenter study on the antidepressant effect of istradefylline for Parkinson's disease

Acronym

Multicenter study on the antidepressant effect of istradefylline for Parkinson's disease

Scientific Title

Multicenter study on the antidepressant effect of istradefylline for Parkinson's disease

Scientific Title:Acronym

Multicenter study on the antidepressant effect of istradefylline for Parkinson's disease

Region

Japan

Condition

Parkinson's disease

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to evaluate the efficacy of istradefylline for the depression found in patients with Parkinson's disease disease presenting wearing off phenomenon.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The changes of score in depresion-related-scales.

Key secondary outcomes

The changes of score in Parkinson's disease disease-related-scales.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Oral administration of istradefilline 20mg / day for 12-week. If the improvement of wearing off is insufficient after 4 weeks, it is possible to increased to 40mg / day.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

The patients who have akinesia with regidity or tremor and diagnosed as Parkinson's disease.
The patients presenting wearing-off phenomenon.
The patients with 3 points or more in Snaith-Hamilton Pleasure Scale Japanese version or 16 points or more in Apathy Scale or 14 points or more in Beck Depression Inventory-II.
The patients with 23 points or more in Mini Mental State Examination.

Key exclusion criteria

The patients who are expected to change anti-parkinsonian drugs during the study.
The patients who have marked psychiatric fluctuation.
The patients who take the following agents: ketoconazole, Rifampicin, midazolam, atorvastatin or digoxin.
The patients with current smoker.

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Hiroshi Nagayama

Organization

Nippon Medical School

Division name

Neurology

Zip code

Address

1-1-5, Sendagi, Bunkyo-Ku, Tokyo

TEL

03-3822-2131

Email

nagayama@nms.ac.jp

Name of contact person

1st name
Middle name
Last name	Hiroshi Nagayama

Organization

Nippon Medical School

Division name

Neurology

Zip code

Address

1-1-5, Sendagi, Bunkyo-Ku, Tokyo

TEL

03-3822-2131

Homepage URL

Email

nagayama@nms.ac.jp

Institute

Nippon Medical School

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

日本医科大学付属病院（東京都）、順天堂大学医学部附属順天堂医院（東京都）、東邦大学医療センター大森病院（東京都）、東京都健康長寿医療センター（東京都）、東京大学医学部附属病院（東京都）、昭和大学病院（東京都）

Date of disclosure of the study information

2016

Year

04

Month

21

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

https://www.sciencedirect.com/science/article/pii/S0022510X18304581?via%3Dihub

Number of participants that the trial has enrolled

Results

Thirty PD patients were enrolled. All patients had scores of higher than cut-off level in at least one of the following batteries: Snaith-Hamilton Pleasure Scale Japanese version (SHAPS-J), Apathy scale, or Beck Depression Inventory-2nd edition (BDI). Following study enrollment, all patients received 20 mg of istradefylline, and the dose was increased to 40 mg after 4 weeks. Results from these 3 batteries and the Unified Parkinson's Disease Rating Scale (UPDRS) score were assessed every 2 to 4 weeks until 12 weeks and the changes in these scores were analyzed. Following administration of istradefylline, the scores of SHAPS-J, Apathy scale, and BDI were significantly improved over time.

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

Recruitment status

Completed

Date of protocol fixation

2016

Year

02

Month

10

Day

Date of IRB

Anticipated trial start date

2016

Year

08

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

04

Month

21

Day

Last modified on

2019

Year

01

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025374