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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003199
Receipt No. R000003878
Scientific Title Projects of Multimodal Brain Imaging of affective disorders
Date of disclosure of the study information 2010/02/17
Last modified on 2014/05/03

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Basic information
Public title Projects of Multimodal Brain Imaging of affective disorders
Acronym Investigating biomarkers for affective disorders
Scientific Title Projects of Multimodal Brain Imaging of affective disorders
Scientific Title:Acronym Investigating biomarkers for affective disorders
Region
Asia(except Japan)

Condition
Condition Bipolar disorders, Major depressive disorders and healthy controls.
Classification by specialty
Psychosomatic Internal Medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Using different imaging modalities to investigate possible biomarkers for differentiating subtypes of affective disorders.
Basic objectives2 Others
Basic objectives -Others Not for treatment-efficacy but for investigating brain differences between groups.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes to see if central glucose metabolism, brain structures and executive functions could differentiate subtypes of affective disorders
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Medication treatment for Bipolar I
Interventions/Control_2 Medication treatment for Bipolar II
Interventions/Control_3 Medication treatment for MDD
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
21 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria Bipolar disorders and Major depressive disorders based on the Fourth Edition of the Diagnostic and Statistical Manual system (DSM-IV) criteria
Key exclusion criteria no alcohol or substance abuse history, no major physical or neurological illness, and no comorbidity with schizophrenia, bipolar disorders, other major psychoses, obsessive-compulsive spectrum disorders, post-traumatic stress disorder, or Cluster B personality disorders.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tung-Ping Tom Su
Organization Taipei Veterans General Hospital, Taiwan
Division name Psychiatry Department
Zip code
Address No.201, Sec.2, Shih-Pai Rd, Beitou District, Taipei, Taiwan
TEL 886-2-28757027(280)
Email tpsu@vghtpe.gov.tw

Public contact
Name of contact person
1st name
Middle name
Last name Cheng-Ta Li
Organization Taipei Veterans General Hospital,Taiwan
Division name Psychiatry Department
Zip code
Address 24 Courthouse Square #502, Rockville, MD, USA, 20850
TEL 240-403-7159
Homepage URL
Email cheng-ta.li@nih.gov

Sponsor
Institute National Science Council, Taiwan
Institute
Department

Funding Source
Organization National Science Council, Taiwan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Taiwan

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 Taipei Veterans General Hospital (Taipei)

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 17 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 Open public recruiting
Date of protocol fixation
2006 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2006 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
2010 Year 02 Month 17 Day
Last modified on
2014 Year 05 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003878

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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