UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014204 |
|---|---|
| Receipt number | 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 13:43:44 |
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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
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
nakatou@med.hokudai.ac.jp
Sponsor or person
Institute
Department of Psychiatry, Hokkaido University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016539
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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