UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004082 |
|---|---|
| Receipt number | 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 20:16:47 |
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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
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
knarita@med.gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004919
