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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014204
Receipt No. R000016539
Scientific Title A pilot study to assess the tolerability and the effectiveness of combination treatment of olanzapine and escitalpram for bipolar depression in Japan
Date of disclosure of the study information 2014/06/08
Last modified on 2018/08/28

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Basic information
Public title A pilot study to assess the tolerability and the effectiveness of combination treatment of olanzapine and escitalpram for bipolar depression in Japan
Acronym OLE-BD study
Scientific Title A pilot study to assess the tolerability and the effectiveness of combination treatment of olanzapine and escitalpram for bipolar depression in Japan
Scientific Title:Acronym 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
1st name
Middle name
Last name Yasuya Nakato
Organization Hokkaido University Hospital
Division name Department of Psychiatry
Zip code
Address Kita 15, Nishi 7, Kita-ku, Sapporo
TEL 011-716-1161
Email nakatou@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuya Nakato
Organization Hokkaido University Hospital
Division name Department of Psychiatry
Zip code
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)

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 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

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 06 Month 08 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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