Status:
COMPLETED
Olanzapine Versus Lithium in the Treatment of Acute Depression in Patients With Bipolar II or Bipolar Not Otherwise Specified(OL Study)
Lead Sponsor:
Tadashi Hasegawa
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2019
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02287259
Start Date
November 1 2014
End Date
March 31 2019
Last Update
December 5 2019
Active Locations (1)
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1
Chiba University Hospital
Chiba, Japan