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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- ├ůsberg 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

Page last updated: August 23, 2015

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