UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001043 |
|---|---|
| Receipt number | R000001250 |
| Scientific Title | Prediction of lithium carbonate response in treatment-resistant depression using brain imaging |
| Date of disclosure of the study information | 2008/03/01 |
| Last modified on | 2011/03/29 16:03:06 |
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Basic information
Public title
Prediction of lithium carbonate response in treatment-resistant depression using brain imaging
Acronym
Prediction of lithium augmentation in treatment-resistant depression
Scientific Title
Prediction of lithium carbonate response in treatment-resistant depression using brain imaging
Scientific Title:Acronym
Prediction of lithium augmentation in treatment-resistant depression
Region
| Japan |
Condition
Condition
Treatment-resistant Depression
Classification by specialty
| Psychiatry | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to investigate which abnormalities of SPECT would be predictors of lithium augmentation for treatment-resistant depression
Basic objectives2
Others
Basic objectives -Others
We aim to investigate predictors of effectiveness.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
After the augmentation therapy, the patients will be divided into responders (a 50% or greater decrease in HAM-D scores between before and after treatment) and non-responders (less than 50%). The predictors (the differences between responders and non-responders) will be analyzed using mental and physical assessments including brain imaging before the therapy.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
This study should be conducted in voluntary inpatients who meet DSM-IV-TR criteria for major depression and are resistant to conventional antidepressant pharmacotherapy.
Treatment resistance is defined by history of failure to respond to antidepressants of more than two different classes, one of which should be TCA, after at least 4 weeks of therapy at an acceptable therapeutic dose.
Written informed consent should be obtained voluntarily from all participants after the purpose, the methods and means, the effects, and the inconveniences and hazards have been fully explained.
Key exclusion criteria
Patients should be free of an experience of lithium augmentation during this episode. Other exclusion criteria are: present or previous history of brain infarction; present history of severe unstable physical illness including thyroidal dysfunction and glaucoma; hypersensitivity of lithium; fertile and sexually active women not on contraceptives; present use of epinephrine; high risk of suicide.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nagahisa Okamoto |
Organization
National Center of Neurology and Psychiatry, Musashi Hospital
Division name
Department of Psychiatry
Zip code
Address
4-1-1, Ogawahigashi-machi, Kodaira City, Tokyo
TEL
042-341-2711
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mayumi Sato |
Organization
National Center of Neurology and Psychiatry, Musashi Hospital
Division name
Department of Psychiatry
Zip code
Address
TEL
042-341-2711
Homepage URL
Sponsor or person
Institute
National Center of Neurology and Psychiatry, Musashi Hospital
Institute
Department
Personal name
Funding Source
Organization
The Grant-in-Aid for Psychiatric and Neurological Diseases and Mental Health from the Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
Preinitiation
Date of protocol fixation
| 2007 | Year | 10 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 12 | Month | 01 | Day |
Other
Other related information
The predictors (the differences between responders and non-responders) will be analyzed using mental (Temperament and Character Inventory, Hamilton Rating Scale for Depression, Beck Depression Inventory II, Clinical Global Impression, Mini Mental State Examination
)and physical(SPECT, MRI, etc.)assessments .
Management information
Registered date
| 2008 | Year | 02 | Month | 20 | Day |
Last modified on
| 2011 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001250
| 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 |
