NCT02287259

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 10, 2014

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

December 5, 2019

Status Verified

December 1, 2019

Enrollment Period

4.4 years

First QC Date

October 30, 2014

Last Update Submit

December 3, 2019

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • Change in Montgomery- Åsberg Depression Rating(MADRS)

    Baseline and 8 weeks

Secondary Outcomes (4)

  • Change in Young Mania Rating Scale(YMARS)

    Baseline and 8 weeks

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

    Baseline and 8 weeks

  • State Trait Anxiety Inventory Form JYZ(STAI)

    Baseline and 8 weeks

  • Clinical Global Impression for Bipolar Disorder(CGI-BP)

    Baseline and 8 weeks

Study Arms (2)

Olanzapine

EXPERIMENTAL

PO start with 2.5mg daily once for 7days, since then flexible dose.

Drug: olanzapine

Lithium

ACTIVE COMPARATOR

PO start with 400mg daily twice for 7days, since then flexible dose.

Drug: lithium

Interventions

olanzapineDRUG
Olanzapine
lithiumDRUG
Lithium

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • major depressive episode in type2 bipolar disorder or bipolar disorder NOS.(MADRS more than 20 point)
  • years to 65years
  • subjects who sign the informed consent document

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chiba University Hospital

Chiba, Japan

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

OlanzapineLithium

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMetals, AlkaliElementsInorganic ChemicalsMetals, LightMetals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
medical doctor(assistant professor)

Study Record Dates

First Submitted

October 30, 2014

First Posted

November 10, 2014

Study Start

November 1, 2014

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

December 5, 2019

Record last verified: 2019-12

Locations

JP(1)