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Completed

NCT Number: NCT02287259

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

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

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chiba University Hospital

Chiba, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olanzapine

Drug

Lithium

Drug

Primary outcomes

  1. Change in Montgomery- Åsberg Depression Rating(MADRS)

    Time frame: Baseline and 8 weeks

Secondary outcomes

  1. Change in Young Mania Rating Scale(YMARS)

    Time frame: Baseline and 8 weeks

  2. Quick Inventory of Depressive Symptomatology Japanese version(QIDS-J)

    Time frame: Baseline and 8 weeks

  3. State Trait Anxiety Inventory Form JYZ(STAI)

    Time frame: Baseline and 8 weeks

  4. Clinical Global Impression for Bipolar Disorder(CGI-BP)

    Time frame: Baseline and 8 weeks

Sponsors and collaborators

Lead sponsor

Tadashi Hasegawa

Other

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Nov 10, 2014
Registry last updated
Dec 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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