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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000001043
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute National Center of Neurology and Psychiatry, Musashi Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001250

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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