UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024726
Receipt number R000028450
Scientific Title Examination about the curative effect of Mirtazapine for the QOL of the pulmonary tumor patient.
Date of disclosure of the study information 2017/04/01
Last modified on 2020/05/11 12:26:25

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Basic information

Public title

Examination about the curative effect of Mirtazapine for the QOL of the pulmonary tumor patient.

Acronym

Examination about the curative effect of Mirtazapine for the QOL of the pulmonary tumor patient.

Scientific Title

Examination about the curative effect of Mirtazapine for the QOL of the pulmonary tumor patient.

Scientific Title:Acronym

Examination about the curative effect of Mirtazapine for the QOL of the pulmonary tumor patient.

Region

Japan


Condition

Condition

Lung cancer and suspected case

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To confirm that a lung cancer doubt patient has the symptom of depression and
it would be recovered by the early treatment.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change of the total Hospital Anxiety and Depression Scale (HADS) score before and after 4 weeks treatment with mirtazapine.

Key secondary outcomes

Quick Inventory of Depressive Symptomatology (QIDS-J),Clinical Global Impression of Improvement (CGI).The change of the total HADS score during the observation period in the non-group given mirtazapine.
A comparison of HADS in a mirtazapine treatment group and the non-treatment group.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

We carry out HADS (Hospital Anxiety and Depression Scale) to a patient of the lung cancer doubt, and having depressive symptom or not is screened. We give mirtazapine 15mg(after 14 days, up to 30mg) to patients more than 11 points day after day.After 4 weeks, we carry out HADS agein.

Interventions/Control_2

Patients who do not agree taking mirtazapine also carry HADS test agein after 4 week.

Interventions/Control_3

We carry out HADS to the patient (lower than HADS10 mark) without the depressive symptom equally four weeks later.

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

The patient who received written enough explanation about a purpose, a method, the significance of this study with a document agreement.

Key exclusion criteria

The patient who could not carry out HADS or was refused. The patient who has a history of the past with hypersensitivity for mirtazapine. The patient with a history of the past with brain disorder (including dementia and Parkinson's disease) of the tissue except the metastasis to brain.
The patient with the past of Mental disease medicine treatment except the sleep inducing drug within three months.
The patient with severe hepatic dysfunction or renal dysfunction.
The patients with the past of suicide consideration or suicide project.
The patients who receive medical treatment with heart trouble (myocardial infarction, angina, conduction disorder).
The patient with glaucoma or the intraocular pressure sthenia. The patients who receive medical treatment with dysuria.
During a pregnant woman, the nursing and the patient who may be pregnant.
The patient who takes a monoamine oxidase inhibitor (MAOI) within two weeks.
The patient who judged that the examination medical attendant was inappropriate.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Koichi
Middle name
Last name Takayama

Organization

Kyoto Prefectural University of Medicine

Division name

Pulmonary Medicine

Zip code

602-8566

Address

465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566

TEL

075-251-5513

Email

takayama@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name Yoshiko
Middle name
Last name Kaneko

Organization

Kyoto Prefectural University of Medicine

Division name

Pulmonary Medicine

Zip code

602-8566

Address

465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566

TEL

075-251-5513

Homepage URL


Email

kaneko-y@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

Kyoto Prefectural University of Medicine

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto Prefectural University of Medicine

Address

465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566

Tel

075-251-5513

Email

kaneko-y@koto.kpu-m.ac.jp


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



Other administrative information

Date of disclosure of the study information

2017 Year 04 Month 01 Day


Related information

URL releasing protocol

http://kokyu-kpum.com/study/

Publication of results

Unpublished


Result

URL related to results and publications

https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi

Number of participants that the trial has enrolled

43

Results

The results showed that patients with depression reported a worse quality of life than those without depression. Compared with no medication, the administration of mirtazapine alleviated depressive symptoms. Furthermore, the patients depressive status was affected by their physical symptoms, including coughing, tightness of chest, and dyspnea.

Results date posted

2020 Year 05 Month 11 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Patients who have been admitted to the hospital for bronchoscopy for detailed examination of lung cancer

Participant flow

A questionnaire survey was conducted at the time of hospitalization and first outpatient examination.

Adverse events

none

Outcome measures

HADS
FACT-L

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2017 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2017 Year 04 Month 01 Day

Last follow-up date

2018 Year 08 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2019 Year 03 Month 01 Day


Other

Other related information



Management information

Registered date

2016 Year 11 Month 06 Day

Last modified on

2020 Year 05 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028450


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name