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
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
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
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
