Back to resultsOlanzapine Versus Lithium in the Treatment of Acute Depression in Patients With Bipolar II or Bipolar Not Otherwise Specified(OL Study)
Primary Purpose
Bipolar Disorder
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
olanzapine
lithium
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder
Eligibility Criteria
Inclusion Criteria:
- major depressive episode in type2 bipolar disorder or bipolar disorder NOS.(MADRS more than 20 point)
- 18years to 65years
- subjects who sign the informed consent document
Exclusion Criteria:
- don't have Diabetes and abnormal metabolism of sugar
- not noticed as bipolar disorder
- have an organic brain disease
- pregnant or breastfeeding women
- don't have heart disease
- have actively suicidal thought(Suicidal ideation score of MADRS is 6)
- who are judged by the investigator to should be excluded from the study
Sites / Locations
- Chiba University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Olanzapine
Lithium
Arm Description
PO start with 2.5mg daily once for 7days, since then flexible dose.
PO start with 400mg daily twice for 7days, since then flexible dose.
Outcomes
Primary Outcome Measures
Change in Montgomery- Åsberg Depression Rating(MADRS)
Secondary Outcome Measures
Change in Young Mania Rating Scale(YMARS)
Quick Inventory of Depressive Symptomatology Japanese version(QIDS-J)
State Trait Anxiety Inventory Form JYZ(STAI)
Clinical Global Impression for Bipolar Disorder(CGI-BP)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02287259
Brief Title
Olanzapine Versus Lithium in the Treatment of Acute Depression in Patients With Bipolar II or Bipolar Not Otherwise Specified(OL Study)
Official 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.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
November 2014 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
March 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tadashi Hasegawa
4. Oversight
5. Study Description
Brief Summary
Determine the efficacy and tolerability of olanzapine for treatment of acute depression in patients with bipolar II or bipolar disorder NOS compared with lithium.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Olanzapine
Arm Type
Experimental
Arm Description
PO start with 2.5mg daily once for 7days, since then flexible dose.
Arm Title
Lithium
Arm Type
Active Comparator
Arm Description
PO start with 400mg daily twice for 7days, since then flexible dose.
Intervention Type
Drug
Intervention Name(s)
olanzapine
Intervention Type
Drug
Intervention Name(s)
lithium
Primary Outcome Measure Information:
Title
Change in Montgomery- Åsberg Depression Rating(MADRS)
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Change in Young Mania Rating Scale(YMARS)
Time Frame
Baseline and 8 weeks
Title
Quick Inventory of Depressive Symptomatology Japanese version(QIDS-J)
Time Frame
Baseline and 8 weeks
Title
State Trait Anxiety Inventory Form JYZ(STAI)
Time Frame
Baseline and 8 weeks
Title
Clinical Global Impression for Bipolar Disorder(CGI-BP)
Time Frame
Baseline and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
major depressive episode in type2 bipolar disorder or bipolar disorder NOS.(MADRS more than 20 point)
18years to 65years
subjects who sign the informed consent document
Exclusion Criteria:
don't have Diabetes and abnormal metabolism of sugar
not noticed as bipolar disorder
have an organic brain disease
pregnant or breastfeeding women
don't have heart disease
have actively suicidal thought(Suicidal ideation score of MADRS is 6)
who are judged by the investigator to should be excluded from the study
Facility Information:
Facility Name
Chiba University Hospital
City
Chiba-shi
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Olanzapine Versus Lithium in the Treatment of Acute Depression in Patients With Bipolar II or Bipolar Not Otherwise Specified(OL Study)
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