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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002553
Receipt No. 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

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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
Email 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
Email kaneday-tsh@umin.ac.jp

Sponsor
Institute Iwaki Clinic
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003118

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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