UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044939 |
|---|---|
| Receipt number | R000051332 |
| Scientific Title | The study about anti-depression mechanism of dopamine partial agonist |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2021/07/22 11:48:13 |
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Basic information
Public title
The study about anti-depression mechanism of dopamine partial agonist
Acronym
The study about anti-depression mechanism of dopamine partial agonist
Scientific Title
The study about anti-depression mechanism of dopamine partial agonist
Scientific Title:Acronym
The study about anti-depression mechanism of dopamine partial agonist
Region
| Japan |
Condition
Condition
major depressive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether dopamine neurotransmission in the brain reward system is involved in the mechanism of action of aripiprazole.
Basic objectives2
Others
Basic objectives -Others
Mechanism of action of a drug
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Neural response of ventral striatum during moneta
ry incentive delay task measured by functional MRI
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Single dose of aripiprazole 3mg
Interventions/Control_2
Single dose of same amount of placebo
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Diagnosed with major depressive disorder
2. Age between 20 and 60 years at the time of consent
3. Treated with escitalopram or sertraline and with any residual symptoms
4. Has give his/her written consent by his/her free will with sufficient explanation and understanding for participation in this study
Key exclusion criteria
1. history of serious physical disease or head
injury
2. history of neuropsychiatric disease other than major depressive disorder
3. history of manic or hypomanic episodes.
4. history of treatment with aripiprazole within 6 months.
5. being treated with antipsychotic drugs, dopamine agonist drugs, or brexpiprazole.
6. any other person deemed inappropriate by the physician.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Hashimoto |
Organization
Hokkaido University
Division name
Department of Psychiatry, Graduate School of Medicine
Zip code
060-8638
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, Japan
TEL
0117065160
hashinao@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Hashimoto |
Organization
Hokkaido University
Division name
Department of Psychiatry, Graduate School of Medicine
Zip code
060-8638
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, Japan
TEL
0117065160
Homepage URL
hashinao@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Ministory of education, culture, sports, science and technology, Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Certified Review Board
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Japan, Hokkaido
Tel
0117067934
madoguchi@huhp.hokudai.ac.jp
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
| 2021 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 07 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 22 | Day |
Last modified on
| 2021 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051332
