UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An randomized comparative study of efficacy and safety between mirtazapine and duloxetine hydrochloride in patients with cancer
Title of the study (Brief title)	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	Nishimura ryouji
Organization	Fukuoka University Faculty of Medicine
Division name	Department of Psychiarty
Address	7-45-1, Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan
TEL	092-801-1011
Email

Public contact
Name of contact person	Matsushita michihiko
Organization	Fukuoka University Faculty of Medicine
Division name	Department of Psychiarty
Address	7-45-1, Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan
TEL	092-801-1011
Homepage URL
Email	matsushita@fukuoka-u.ac.jp

Sponsor
Institute	Fukuoka University Faculty of Medicine Department of Psychiarty
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 05 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010306