UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002981 |
|---|---|
| Receipt number | R000003619 |
| Scientific Title | The effect of an educational leaflet on depressive patients attitudes toward treatment. |
| Date of disclosure of the study information | 2010/01/06 |
| Last modified on | 2010/06/03 14:04:43 |
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Basic information
Public title
The effect of an educational leaflet on depressive patients attitudes toward treatment.
Acronym
The effect of an educational leaflet on depressive patients attitudes toward treatment.
Scientific Title
The effect of an educational leaflet on depressive patients attitudes toward treatment.
Scientific Title:Acronym
The effect of an educational leaflet on depressive patients attitudes toward treatment.
Region
| Japan |
Condition
Condition
Depressive disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of an educational leaflet designed to improve patients attitudes toward depression and antidepressant treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Antidepressant Compliance Questionnaire(ADCQ)
Key secondary outcomes
Beck Depression Inventory (BDI)
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
From October 1, 2005 to February 28, 2006.
Intervention group: Received the educational leaflet designed to improve patients attitudes toward depression and antidepressant treatment at the start of the study.
Interventions/Control_2
From October 1, 2005 to February 28, 2006.
Control group: Usual 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outpatients who met the DSM-IV criteria for major depressive disorder, dysthymic disorder, and depressive disorder not otherwise specified.
Key exclusion criteria
No exclusion criteria
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Teruhiko Higuchi |
Organization
National Center of Neurology and Psychiatry
Division name
President
Zip code
Address
4-1-1 Ogawa-higasi, Kodaira, Tokyo, 187-8551 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kanae Sawamura |
Organization
Institute for Health Economics and Policy
Division name
Research department
Zip code
Address
No.11 Toyo-Kaiji Bldg, 1-5-11, Nishi-Sinbashi, Minato-ku, Tokyo,105-0003 Japan
TEL
03-3506-8529
Homepage URL
sawa-tky@umin.ac.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2010 | Year | 01 | Month | 06 | 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
| 2005 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 01 | Month | 06 | Day |
Last modified on
| 2010 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003619
