Olanzapine Versus Lithium in the Treatment of Acute Depression in Patients With Bipolar II or Bipolar Not Otherwise Specified(OL Study)
- Registration Number
- NCT02287259
- Lead Sponsor
- Tadashi Hasegawa
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Olanzapine olanzapine PO start with 2.5mg daily once for 7days, since then flexible dose. Lithium lithium PO start with 400mg daily twice for 7days, since then flexible dose.
- Primary Outcome Measures
Name Time Method Change in Montgomery- Åsberg Depression Rating(MADRS) Baseline and 8 weeks
- Secondary Outcome Measures
Name Time Method Change in Young Mania Rating Scale(YMARS) Baseline and 8 weeks Quick Inventory of Depressive Symptomatology Japanese version(QIDS-J) Baseline and 8 weeks State Trait Anxiety Inventory Form JYZ(STAI) Baseline and 8 weeks Clinical Global Impression for Bipolar Disorder(CGI-BP) Baseline and 8 weeks
Trial Locations
- Locations (1)
Chiba University Hospital
🇯🇵Chiba-shi, Japan
Chiba University Hospital🇯🇵Chiba-shi, Japan