UMIN-CTR Clinical Trial

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

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

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
Last 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
1st 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

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	2014 Year 08 Month 25 Day
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