UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002553 |
|---|---|
| Receipt number | R000003118 |
| Scientific Title | Verbal working memory and functional outcome in patients with unipolar major depressive disorder: a prospective study |
| Date of disclosure of the study information | 2009/09/27 |
| Last modified on | 2013/09/27 23:12:10 |
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Basic information
Public title
Verbal working memory and functional outcome in patients with unipolar major depressive disorder: a prospective study
Acronym
Working memory and functional outcome in depressive patients
Scientific Title
Verbal working memory and functional outcome in patients with unipolar major depressive disorder: a prospective study
Scientific Title:Acronym
Working memory and functional outcome in depressive patients
Region
| Japan |
Condition
Condition
Depression.
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the suggestion that verbal working memory is predictive of the functional outcome in patients with major depressive disorder after remission.
Basic objectives2
Others
Basic objectives -Others
Neuropsycholgy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relation between verbal working memory and functional outcome in patients with major depressive disorder after remission.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
12-weeks follow-up with antidepressant drugs.
Interventions/Control_2
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who satisfied the DSM-IV criteria for a current episode of unipolar major depressive disorder (non-psychotic).
Key exclusion criteria
Patients had no comorbid psychiatric disorders, or any medical, neurological, or developmental conditions that could affect cognition (e.g., ADHD, brain injury, MCI, chronic pain).
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro KANEDA |
Organization
Iwaki Clinic
Division name
Psychiatry
Zip code
Address
11-1 Kamimizuta, Gakubara, Anan, Tokushima 774-0014, Japan
TEL
+81-884-23-5600
kaneday-tsh@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiro KANEDA |
Organization
Iwaki Clinic
Division name
Psychiatry
Zip code
Address
11-1 Kamimizuta, Gakubara, Anan, Tokushima 774-0014, Japan
TEL
+81-884-23-5600
Homepage URL
kaneday-tsh@umin.ac.jp
Sponsor or person
Institute
Iwaki Clinic
Institute
Department
Personal name
Funding Source
Organization
Daido Life Welfare Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
The Japanese Association of Neuro-Psychiatric Clinics (Ken TANAKA Memorial Grant), and the Charitable Organization Kimi IMAI Memorial Stress Associated Diseases Research Aid Fund.
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
| 2009 | Year | 09 | Month | 27 | 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
| 2008 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 09 | 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
| 2009 | Year | 09 | Month | 27 | Day |
Last modified on
| 2013 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003118
