UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006218 |
|---|---|
| Receipt number | R000007362 |
| Scientific Title | A open-label, randomized study of olanzapine in the maintenance treatment of bipolar disorder |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2011/08/23 19:44:23 |
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Basic information
Public title
A open-label, randomized study of olanzapine in the maintenance treatment of bipolar disorder
Acronym
A study of olanzapine in the maintenance treatment of bipolar disorder (OL Study)
Scientific Title
A open-label, randomized study of olanzapine in the maintenance treatment of bipolar disorder
Scientific Title:Acronym
A study of olanzapine in the maintenance treatment of bipolar disorder (OL Study)
Region
| Japan |
Condition
Condition
Bipolar disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study was designed to evaluate the effectiveness of olanzapine in the maintenance treatment of bipolar disorder.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The recurrence rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Olanzapine, 52 weeks or less
Interventions/Control_2
Lithium, 52 weeks or less
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
With a diagnosis of bipolar disorder and noticed as bipolar disorder.
Key exclusion criteria
With diabetes or disorder of carbohydrate metabolism.
With a serious suicide risk.
Pregnant or breastfeeding women.
Not noticed as bipolar disorder.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaomi Iyo |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Psychiatry
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mihisa Fujisaki |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Psychiatry
Zip code
Address
TEL
Homepage URL
fujisaki@faculty.chiba-u.jp
Sponsor or person
Institute
Graduate School of Medicine, Chiba University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2011 | Year | 09 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 08 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 23 | Day |
Last modified on
| 2011 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007362
