UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002334 |
|---|---|
| Receipt number | R000002858 |
| Scientific Title | Effect of dopamine receptor agonists on treatment-resistant depression |
| Date of disclosure of the study information | 2009/08/15 |
| Last modified on | 2013/08/16 06:43:29 |
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Basic information
Public title
Effect of dopamine receptor agonists on treatment-resistant depression
Acronym
DATRD
Scientific Title
Effect of dopamine receptor agonists on treatment-resistant depression
Scientific Title:Acronym
DATRD
Region
| Japan |
Condition
Condition
treatment-resistant depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of dopamine receptor agonists for treatment-resistant depression
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hamilton Depression Rating Scale (HDRS), Montgomery-Asberg Depression Rating Scale (MADRS)
Key secondary outcomes
Global Assessment of Functioning (GAF), side effects, FDG-PET, MRI, plasma HVA
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
treatment with dopamine receptor agonist
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
depressed patients, who have significant and moderate depressive symptoms despite at least two adequate trials with antidepressants from different classes
Key exclusion criteria
1) allergy for dopamine agonists, 2) allergy for antidepressants, 3) severe psychotic symptoms, 4) consciousness disturbance, 5) severe hypotension, 6) severe physical disease (heart, lung, liver, kidney, bone marrow, endocrine), 7)peripheral vascular disease, 8) active ulcer, 9) pregnancy, breast-feeding, 10) subjects, whom investigators consider inappropriate
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Inoue |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
Address
Kita 15, Nishi 7, Kita-ku, Sapporo
TEL
011-716-1161
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Inoue |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
Address
Kita 15, Nishi 7, Kita-ku, Sapporo
TEL
011-716-1161
Homepage URL
Sponsor or person
Institute
Department of Psychiatry, Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Psychiatry, Hokkaido University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
| 2009 | Year | 08 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://www.sciencedirect.com/science/article/pii/S0278584610003015
Number of participants that the trial has enrolled
Results
Pramipexole was effective for treatment-resistant depression in our small open study.
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
Completed
Date of protocol fixation
| 2005 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 08 | Month | 16 | Day |
Date of closure to data entry
| 2013 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 14 | Day |
Last modified on
| 2013 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002858
| 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 |
