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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004082
Receipt No. R000004919
Scientific Title Examination regarding hypothalamus-pituitary-adrenal axis activity in mood disorder and post-traumatic stress disorder (PTSD) as determined by Dexamethasone/corticotropin releasing hormone (DEX/CRH) test
Date of disclosure of the study information 2010/08/22
Last modified on 2012/04/10

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Basic information
Public title Examination regarding hypothalamus-pituitary-adrenal axis activity in mood disorder and post-traumatic stress disorder (PTSD) as determined by Dexamethasone/corticotropin releasing hormone (DEX/CRH) test
Acronym Dexamethasone/corticotropin releasing hormone test in mood disorder and post-traumatic stress disorder
Scientific Title Examination regarding hypothalamus-pituitary-adrenal axis activity in mood disorder and post-traumatic stress disorder (PTSD) as determined by Dexamethasone/corticotropin releasing hormone (DEX/CRH) test
Scientific Title:Acronym Dexamethasone/corticotropin releasing hormone test in mood disorder and post-traumatic stress disorder
Region
Japan

Condition
Condition mood disorder, post-traumatic stress disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Assessment of hypothalamus-pituitary-adrenal axis activity in mood disorder and post-traumatic stress disorder (PTSD)
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Association between psychological measurement and plasma cortisol concentration after dexamethasone oral administration and CRH infusion.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Dexamethasone 1mg tablet and iv corticotropin releasing hormone (100ug)
Interventions/Control_2 Dexamethasone 1.5mg tablet and iv corticotropin releasing hormone (100ug)
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The following inclusion criteria is used: mood disorders (i.e., unipolar or bipolar), post-traumatic stress disorder, and healthy volunteers. To assess the subjects with past or current major mental disorders or personality disorders, the Structured Clinical Interview for DSM-IV Axis I Disorders are used
Key exclusion criteria The following exclusion criteria is used: a history of a neurological illness, chronic alcoholism, or substance abuse
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kosuke Narita
Organization Gunma University Graduate School of Medicine
Division name Department of Psychiatry and Neuroscience
Zip code
Address 3-39-22 Showa-machi, Maebashi, Gunma 371-8511, Japan
TEL +81272208185
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kosuke Narita
Organization Gunma University Graduate School of Medicine
Division name Department of Psychiatry and Neuroscience
Zip code
Address 3-39-22 Showa-machi, Maebashi, Gunma 371-8511, Japan
TEL +81272208185
Homepage URL
Email knarita@med.gunma-u.ac.jp

Sponsor
Institute Gunma University Graduate School of Medicine
Institute
Department

Funding Source
Organization The Japan Society for the Promotion of Science
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 群馬大学医学部附属病院(群馬県)

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 22 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
2001 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
2013 Year 03 Month 01 Day
Date trial data considered complete
2013 Year 03 Month 01 Day
Date analysis concluded
2013 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 08 Month 22 Day
Last modified on
2012 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004919

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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