UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019990 |
|---|---|
| Receipt number | R000023083 |
| Scientific Title | Efficacy and safety of blonanserin augmentationtherapy for treatment resistance in depression |
| Date of disclosure of the study information | 2015/11/30 |
| Last modified on | 2019/06/19 21:02:36 |
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Basic information
Public title
Efficacy and safety of blonanserin augmentationtherapy for treatment resistance in depression
Acronym
Efficacy and safety of blonanserin augmentationtherapy for treatment resistance in depression
Scientific Title
Efficacy and safety of blonanserin augmentationtherapy for treatment resistance in depression
Scientific Title:Acronym
Efficacy and safety of blonanserin augmentationtherapy for treatment resistance in depression
Region
| Japan |
Condition
Condition
major depressive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our purpose is to clarify efficacy and safety of blonanserin augmentationtherapy for treatment resistance in depression
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The Hamilton Rating Scale for Depression assessment at the 8 weeks after the start of interventions
Key secondary outcomes
Udvalg for kliniske undersogelser side effect rating scale,
Drug Induced Extra-Pyramidal Symptons Scale
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
Blonanserin 1-4 mg will be orally administered once daily after dinner for 8 weeks.
(initial dose: 1mg, maximum dose: 6mg)
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
DSM-4-TR:MDD
Patients with treatment-resistant MDD: aripiprazole 3-15mg
Key exclusion criteria
Patient with the following disorders (based on DSM-IV-TR criteria): psychotic disorders, pervasive developmental disorders, bipolar disorder, obsessive-compulsive disorder, Axis-2 disorder.
Patients with substance abuse or dependence (excluding nicotine and caffeine) meeting DSM-IV-TR criteria
Patients taking MAO inhibitors with in14 days (or Patients treated with MAO inhibitors within 14 days)
Patients taking pimozide
Patients with QT interval prolongation
Patients treated with ECT within the previous 6 months
Patients having severe physical disease
Patients who are pregnant or may become pregnant
Patients at significant risk of suicide (having a score >3 on HAM-D item 11)
Patients who had made suicide attempt within the past year
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nakao Iwata |
Organization
Fujita Health University School of Medicine
Division name
Department of Psychiatry
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi. 470-1192. Japan
TEL
0562-93-9259
nakao@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuki Matsuda |
Organization
Fujita Health University School of Medicine
Division name
Department of Psychiatry
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi. 470-1192. Japan
TEL
0562-93-9259
Homepage URL
myuki@fujita-hu.ac.jp
Sponsor or person
Institute
Department of Psychiatry, Fujita Health University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Psychiatry, Fujita Health University 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
| 2015 | Year | 11 | Month | 30 | 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
Completed
Date of protocol fixation
| 2014 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 30 | Day |
Last modified on
| 2019 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023083
| 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 |
