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NCT02287259 Clinical Trial

Olanzapine Versus Lithium in the Treatment of Acute Depression in Patients With Bipolar II or Bipolar Not Otherwise Specified(OL Study)

Bipolar Disorder Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02287259
Other study ID # ChibaU
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 2014
Est. completion date March 31, 2019

Study information
Verified date December 2019
Source Chiba University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date March 31, 2019
Est. primary completion date March 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• olanzapine

• lithium

Locations
Country Name City State
Japan Chiba University Hospital Chiba-shi

Sponsors (1)
Lead Sponsor Collaborator
Tadashi Hasegawa

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Montgomery- Åsberg Depression Rating(MADRS) Baseline and 8 weeks
Secondary Change in Young Mania Rating Scale(YMARS) Baseline and 8 weeks
Secondary Quick Inventory of Depressive Symptomatology Japanese version(QIDS-J) Baseline and 8 weeks
Secondary State Trait Anxiety Inventory Form JYZ(STAI) Baseline and 8 weeks
Secondary Clinical Global Impression for Bipolar Disorder(CGI-BP) Baseline and 8 weeks
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