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Trial record 14 of 69 for:    "Bipolar Disorder" | "Olanzapine"

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

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ClinicalTrials.gov Identifier: NCT02287259
Recruitment Status : Recruiting
First Posted : November 10, 2014
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Tadashi Hasegawa, Chiba University

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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: olanzapine Drug: lithium Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : November 2014
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

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



Primary Outcome Measures :
  1. Change in Montgomery- Åsberg Depression Rating(MADRS) [ Time Frame: Baseline and 8 weeks ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02287259


Contacts
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Contact: Tadashi Hasegawa, Assistant professor +81-43-222-7171 t0715.hasegawa@gmail.com

Locations
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Japan
Chiba University Hospital Recruiting
Chiba-shi, Japan
Contact: Tadashi Hasegawa       t0715.hasegawa@gmail.com   
Sponsors and Collaborators
Tadashi Hasegawa

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Responsible Party: Tadashi Hasegawa, medical doctor(assistant professor), Chiba University
ClinicalTrials.gov Identifier: NCT02287259     History of Changes
Other Study ID Numbers: ChibaU
First Posted: November 10, 2014    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Bipolar Disorder
Olanzapine
Depression
Behavioral Symptoms
Bipolar and Related Disorders
Mental Disorders
Lithium Carbonate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents
Enzyme Inhibitors
Antimanic Agents