UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007083 |
|---|---|
| Receipt number | R000008343 |
| Scientific Title | A study of efficacy of collaborative care with primary care physician for treatment of Depression (Open-labeled ,multi-facilities randomized case-control study) |
| Date of disclosure of the study information | 2012/01/18 |
| Last modified on | 2017/01/20 11:27:51 |
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Basic information
Public title
A study of efficacy of collaborative care with primary care physician for treatment of Depression
(Open-labeled ,multi-facilities randomized case-control study)
Acronym
A study of efficacy of collaborative care with primary care physician for treatment of Depression
Scientific Title
A study of efficacy of collaborative care with primary care physician for treatment of Depression
(Open-labeled ,multi-facilities randomized case-control study)
Scientific Title:Acronym
A study of efficacy of collaborative care with primary care physician for treatment of Depression
Region
| Japan |
Condition
Condition
Depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study efficacy of collaborative care with primary care physician who treat depression.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PHQ9(Patient Health Questionnaire 9) score
adherence
Rate of Satisfaction of patients for their treatment
Drop-out rate from treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Support patients receiving the treatment by case manager
Interventions/Control_2
standard treatment
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
20y.o. or older diagnosed of Major Depressive Disorder by DSM-IV
Key exclusion criteria
Already receiving treatments of Depression
Pregnant
Breast feeding
Diagnosed or likely diagnosed of Dementia , Alcoholism
Strong Suicidal ideation and actual risk of suicide is imminent
Determined as inappropriate candidate of the study by attending physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Horikawa Naoshi |
Organization
Saitama Medical Center
Division name
Department of psychiatry
Zip code
Address
1981 Kamoda Kawagoe-shi
TEL
049-228-3746
yasuda@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaaki Yasuda |
Organization
Saitama Medical Center
Division name
Department of psychiatry
Zip code
Address
1981 Kamoda Kawagoe-shi
TEL
049-228-3746
Homepage URL
yasuda@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Saitama Prefecture
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
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2011 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 17 | Day |
Last modified on
| 2017 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008343
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
