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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001789
Receipt No. R000002160
Scientific Title Effectiveness of interpersonal psychotherapy for symptom and cognitive function of depressive disorder
Date of disclosure of the study information 2009/03/31
Last modified on 2012/03/29

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Basic information
Public title Effectiveness of interpersonal psychotherapy for symptom and cognitive function of depressive disorder
Acronym Study of interpersonal psychotherapy for depression
Scientific Title Effectiveness of interpersonal psychotherapy for symptom and cognitive function of depressive disorder
Scientific Title:Acronym Study of interpersonal psychotherapy for depression
Region
Japan

Condition
Condition major depressive disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To prove effectiveness of interpersonal psychotherapy for symptom and cognitive function of depressive disorder
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hamilton rating scale for depression
Quick Inventory of Depressive Symptomatology-Self Report
NEO-five factor inventory
Brief accessment cognitive function for schizophrenia
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
Behavior,custom
Interventions/Control_1 Interpersonal psychotherapy
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
55 years-old >=
Gender Male and Female
Key inclusion criteria Patient with major depressive disorder
Written consent was obtained
Key exclusion criteria 1)Hystory of substance abuse, manic episode, or psychotic episode
2)Actively suicidal patients
3)Those who are unable to be followed up for four months
4)Central nerve disease
5)Other any contraindications pointed out by psychiatrist in charge
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazunori Matsumoto
Organization Tohoku University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 1-1, Seiryochou, Aobaku, Sendai, Miyagi
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazunori Matsumoto
Organization Tohoku University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Department of Psychiatry, Tohoku University Hospital
Institute
Department

Funding Source
Organization Tohoku University School
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 東北大学病院

Other administrative information
Date of disclosure of the study information
2009 Year 03 Month 31 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 Completed
Date of protocol fixation
2008 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 10 Month 01 Day
Last follow-up date
2012 Year 06 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 03 Month 23 Day
Last modified on
2012 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002160

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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