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Recruitment status Completed
Unique ID issued by UMIN UMIN000015124
Receipt No. R000017321
Scientific Title A randomized, open label trial of olanzapine versus lithium in the treatment of acute depression in patients with bipolar II or bipolar not otherwise specified.
Date of disclosure of the study information 2014/09/11
Last modified on 2019/03/28

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Basic information
Public title A randomized, open label trial of olanzapine versus lithium in the treatment of acute depression in patients with bipolar II or bipolar not otherwise specified.
Acronym OL study
Scientific Title A randomized, open label trial of olanzapine versus lithium in the treatment of acute depression in patients with bipolar II or bipolar not otherwise specified.
Scientific Title:Acronym OL study
Region
Japan

Condition
Condition Bipolar II disorder or Bipolar disorder not otherwise specified(NOS)
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Determine the efficacy and tolerability of olanzapine for treatment of acute depression in patients with bipolar II or bipolar disorder NOS compared with lithium.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes The primary study endpoint is change in MADRS total
score between baseline and 8 weeks.
Key secondary outcomes YMARS(Young Mania Rating Scale)
QIDS-J(Quick Inventory of Depressive Symptomatology Japanese version)
STAI(State Trait Anxiety Inventory Form JYZ)
TEMPS-A(Temperament Evaluation of Memphis, Pisa, Paris and San Diego)
BSDS(Bipolar Spectrum Diagnostic Scale)
CGI-BP(Clinical Global Impression for Bipolar Disorder)
Bipolarity index
Side effects

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Olanzapine group:starting dose 2.5mg daily once. flexible dose trial.
Interventions/Control_2 Lithium group:starting dose 400mg daily twice. flexible dose trial.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1)major depressive episode in type2 bipolar disorder or 2)bipolar disorder NOS.(MADRS more than 20 point).
3)18years to 65years.
4)subjects who sign the informed consent document.
Key exclusion criteria 1)don't have Diabetes and abnormal metabolism of sugar
2)not noticed as bipolar disorder.
3)have an organic brain disease.
4)pregnant or breastfeeding women.
5)don't have heart disease.
6)have actively suicidal thought(Suicidal ideation score of MADRS is 6).
7)who are judged by the investigator to should be excluded from the study.
Target sample size 236

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 0432227171
Email iyom@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tadashi Hasegawa
Organization Chiba University Hospital
Division name Department of psychiatry
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba
TEL 043-222-7171
Homepage URL
Email t0715.hasegawa@gmail.com

Sponsor
Institute Chiba University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Eli Lilly Japan
Organization
Division
Category of Funding Organization Profit organization
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
2014 Year 09 Month 11 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 25 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 01 Day
Last follow-up date
2019 Year 02 Month 07 Day
Date of closure to data entry
2019 Year 03 Month 16 Day
Date trial data considered complete
2019 Year 03 Month 28 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 09 Month 11 Day
Last modified on
2019 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017321


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