Olanzapine Versus Lithium in the Treatment of Acute Depression in Patients With Bipolar II or Bipolar Not Otherwise Specified(OL Study)
Information source: Chiba University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder
Intervention: olanzapine (Drug); lithium (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Tadashi Hasegawa Overall contact:
Tadashi Hasegawa, Assistant professor, Phone: +81-43-222-7171, Email: t0715.hasegawa@gmail.com
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in Montgomery- Åsberg Depression Rating(MADRS)
Secondary outcome: 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)
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Tadashi Hasegawa, Assistant professor, Phone: +81-43-222-7171, Email: t0715.hasegawa@gmail.com Additional Information
Starting date: November 2014
Last updated: November 7, 2014
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