UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A pilot study to assess the tolerability and the effectiveness of combination treatment of olanzapine and escitalpram for bipolar depression in Japan
Title of the study (Brief title)	OLE-BD study
Region	Japan

Condition
Condition	major depressive episode of bipolar disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aims of this open-label study are: - to assess the tolerability of combination treatment of olanzapine and SSRI, escitalopram in the patients with bipolar depression in Japan - to assess the effectiveness of combination treatment of olanzapine and SSRI, escitalopram in the patients with bipolar depression in Japan
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	effectiveness, improvements in depressive symptoms as measured by the mean change in MADRS total scores from baseline to weeks 8 and 24.
Key secondary outcomes	The secondary objectives of this study are to assess the combination of olanzapine and escitalopram in terms of; -changes in scores of the Clinical Global Impressions-Bipolar Version Severity of Illness (CGI-BP-S) from baseline to weeks 8 and 24. -improvement of subjective depressive symptoms, based on changes from baseline to weeks 8 and 24 in scores of Quick Inventory Depressive Symptomatology-Self Report, Japanese version: QIDS-SRJ). -remission rate of depression, with remission defined as a score =<9 in the MARDS total score or a score =<5 in the QIDS-SRJ total score. -emergence of mania, defined as a score >=12 in the YMRS total score and with >= 2 manic symptoms. -change in body weight, glucose and lipid metabolism, ECG, adverse reaction

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	combination therapy of olanzapine and escitalopram for 8 weeks (the period can be extended up to 24 weeks if there is the efficacy without serious adverse events)
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	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	-Male or female subjects between the ages of 20 and 65 years -subjects meeting diagnostic criteria of The Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV-TR for bipolar I disorder or bipolar II disorder, most recent episode depressed. -subjects who show the poor response to the previous treatment and meet the following criteria - MADRS total scores: more than 19 - YMRS total scores: less than 5 - subjects who receive the same treatment for the last 4 weeks and have the records of medication history in past 4 weeks -subjects who sign the informed consent document
Key exclusion criteria	-subjects who have participated in a clinical trial of another investigational drug within 30 days before study entry -subjects who have a serious, unstable illness or an organic brain disease -subjects who are actively suicidal (Suicidal ideation score of MADRS is more than 3) or are judged clinically to be at serious suicidal risk by the investigator. -subjects who have a diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, personality disorders or substance-related disorders according to DSM-IV-TR -subjects who are contraindicated for use with olanzapine and escitalopram (eg. Having a history or diagnosis of diabetes mellitus) -subjects who have currently (within 2 months) received electoconvulsive therapy (ECT) -subjects who have received the combination therapy of olanzapine and escitalopram -women who are pregnant or provide breast feeding, or may be pregnant -subjects who are judged by the investigator to should be excluded from the study
Target sample size	60

Research contact person
Name of lead principal investigator	Yasuya Nakato
Organization	Hokkaido University Hospital
Division name	Department of Psychiatry
Address	Kita 15, Nishi 7, Kita-ku, Sapporo
TEL	011-716-1161
Email	nakatou@med.hokudai.ac.jp

Public contact
Name of contact person	Yasuya Nakato
Organization	Hokkaido University Hospital
Division name	Department of Psychiatry
Address	Kita 15, Nishi 7, Kita-ku, Sapporo
TEL	011-716-1161
Homepage URL
Email	nakatou@med.hokudai.ac.jp

Sponsor
Institute	Department of Psychiatry, Hokkaido University Hospital
Institute
Department

Funding Source
Organization	Eli Lilly Japan Mitsubishi Tanabe Pharma
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Kawamura Mental Clinic Sapporo City Hospital Ishikane Hosipital Sapporo Suzuki Hospital Sapporo Hanazono Hospital Tomakomai Midorigaoka Hospital Honda Memorial Hospital Maki Hosipital
Name of secondary funｄer(s)

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	北海道大学病院　精神科神経科 （北海道） Department of Psychiatry, Hokkaido University Hospital

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 08 Day
Anticipated trial start date	2014 Year 08 Month 01 Day
Last follow-up date	2017 Year 09 Month 30 Day
Date of closure to data entry	2017 Year 09 Month 30 Day
Date trial data considered complete	2017 Year 09 Month 30 Day
Date analysis concluded	2017 Year 12 Month 28 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 06 Month 08 Day
Last modified on	2018 Year 08 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016539