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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002334
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Psychiatry, Hokkaido University Graduate School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002858

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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