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

December 3, 2019 updated by: Tadashi Hasegawa

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.

Determine the efficacy and tolerability of olanzapine for treatment of acute depression in patients with bipolar II or bipolar disorder NOS compared with lithium.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chiba-shi, Japan
        • Chiba University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Olanzapine
PO start with 2.5mg daily once for 7days, since then flexible dose.
Drug: olanzapine
ACTIVE_COMPARATOR: Lithium
PO start with 400mg daily twice for 7days, since then flexible dose.
Drug: lithium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Montgomery- Åsberg Depression Rating(MADRS)
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Young Mania Rating Scale(YMARS)
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks
Quick Inventory of Depressive Symptomatology Japanese version(QIDS-J)
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks
State Trait Anxiety Inventory Form JYZ(STAI)
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks
Clinical Global Impression for Bipolar Disorder(CGI-BP)
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tadashi Hasegawa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2014

Primary Completion (ACTUAL)

March 31, 2019

Study Completion (ACTUAL)

March 31, 2019

Study Registration Dates

First Submitted

October 30, 2014

First Submitted That Met QC Criteria

November 7, 2014

First Posted (ESTIMATE)

November 10, 2014

Study Record Updates

Last Update Posted (ACTUAL)

December 5, 2019

Last Update Submitted That Met QC Criteria

December 3, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChibaU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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