Olanzapine Versus Lithium in the Treatment of Acute Depre... | NCT02287259

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

NCT02287259

Sponsor

Tadashi Hasegawa

Status

Completed

Last Update Posted

Dec 5, 2019Actual

Enrollment

50Actual

Phase

Phase 4

Conditions

Bipolar Disorder

Interventions

olanzapine
lithium

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014Actual

Primary Completion Date

Mar 31, 2019Actual

Completion Date

Mar 31, 2019Actual

First Submitted Date

Oct 30, 2014

First Submission Date that Met QC Criteria

Nov 7, 2014

First Posted Date

Nov 10, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2019

Last Update Posted Date

Dec 5, 2019Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
olanzapine	Drug		Olanzapine
lithium

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Change in Young Mania Rating Scale(YMARS)		Baseline and 8 weeks
Quick Inventory of Depressive Symptomatology Japanese version(QIDS-J)		Baseline and 8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chiba University Hospital		Chiba			Japan

Condition Browse Module

MeSH Terms

ID	Term
D001714	Bipolar Disorder

Ancestor Terms

ID	Term
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077152	Olanzapine
D008094	Lithium

Ancestor Terms

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided