UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003199 |
|---|---|
| Receipt number | 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 21:27:52 |
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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)
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
cheng-ta.li@nih.gov
Sponsor or person
Institute
National Science Council, Taiwan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003878
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
