UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008768
Receipt number R000010306
Scientific Title An randomized comparative study of efficacy and safety between mirtazapine and duloxetine hydrochloride in patients with cancer
Date of disclosure of the study information 2012/08/25
Last modified on 2017/02/27 11:22:49

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Basic information

Public title

An randomized comparative study of efficacy and safety between mirtazapine and duloxetine hydrochloride in patients with cancer

Acronym

An randomized comparative study of efficacy and safety between mirtazapine and duloxetine hydrochloride in patients

Scientific Title

An randomized comparative study of efficacy and safety between mirtazapine and duloxetine hydrochloride in patients with cancer

Scientific Title:Acronym

An randomized comparative study of efficacy and safety between mirtazapine and duloxetine hydrochloride in patients

Region

Japan


Condition

Condition

Majar depression in cancer patient

Classification by specialty

Psychiatry

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of mirtazapine or duloxetine hydrochloride on the depressive symptoms in patients with cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Change in HAM-D scores between pretreatment baseline and 6-week treatment

Key secondary outcomes

Specific symptoms (pain and nausea)
Adverse events


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation

NO

Institution consideration


Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

antidepressants

Interventions/Control_2

safety

Interventions/Control_3


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Age >= 20 years old
2)Possible oral administration
3)Patient with any cancer
4)Male or female. Inpatient or
outpatient.
5)Written informed consent

Key exclusion criteria

1)Brain metastasis confirmed
2)Congnitive impairment
3)Under interferon therapy
4)Bipolar disorder
5)Convulsive disorder or history of convulsive disorder
6)Prior electroconvulsive therapy
7)Dysuria, glaucoma or treatment for elevated intraocular pressure
8)Administration of the monoamine oxidase (MAO) inhibitor within observation period(2 weeks)
9)Hypersensitivity to mirtazapine or duloxetine hydrochloride
10)Pregnancy or lactating woman, woman planning pregnancy
11)Substance or alcohol abuse 180 days prior to administration of investigational drug.
12)Patient ineligible to the study based on investigator's decision.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nishimura ryouji

Organization

Fukuoka University Faculty of Medicine

Division name

Department of Psychiarty

Zip code


Address

7-45-1, Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan

TEL

092-801-1011

Email



Public contact

Name of contact person

1st name
Middle name
Last name Matsushita michihiko

Organization

Fukuoka University Faculty of Medicine

Division name

Department of Psychiarty

Zip code


Address

7-45-1, Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan

TEL

092-801-1011

Homepage URL


Email

matsushita@fukuoka-u.ac.jp


Sponsor or person

Institute

Fukuoka University Faculty of Medicine Department of Psychiarty

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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

福岡大学病院(福岡県)


Other administrative information

Date of disclosure of the study information

2012 Year 08 Month 25 Day


Related information

URL releasing protocol


Publication of results

Unpublished


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

Terminated

Date of protocol fixation

2012 Year 05 Month 23 Day

Date of IRB


Anticipated trial start date

2012 Year 08 Month 25 Day

Last follow-up date

2013 Year 04 Month 01 Day

Date of closure to data entry

2013 Year 09 Month 01 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 08 Month 25 Day

Last modified on

2017 Year 02 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010306


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name