Optimal Duration of Olanzapine Add-on Therapy in Major De... | NCT00568672

Studies
Optimal Duration of Olanzapine Add-on Therapy in Major Depression

NCT00568672

Sponsor

Charite University, Berlin, Germany

Status

Withdrawn

Last Update Posted

Feb 9, 2023Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Relapse Rate of a Major Depressive Episode
Safety of Olanzapine in Subjects With Major Depression

Interventions

Olanzapine

Countries

Germany

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

Feb 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Withdrawn because of personal ressources before inclusion of the first patient

Expanded Access Info

Start Date

Oct 2007Estimated

Primary Completion Date

Jan 2008Estimated

Completion Date

Apr 2008Estimated

First Submitted Date

Dec 5, 2007

First Submission Date that Met QC Criteria

Dec 5, 2007

First Posted Date

Dec 6, 2007Estimated

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

Feb 7, 2023

Last Update Posted Date

Feb 9, 2023Actual

Name	Class
Eli Lilly and Company	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Evaluation of olanzapine versus placebo in the continuation therapy of subjects with major depression who had a response with additional olanzapine to an antidepressant.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Olanzapine 5 mg / day	Drug: Olanzapine
2	Placebo Comparator	Placebo	Drug: Olanzapine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Olanzapine	Drug	Olanzapine 5 mg / day for 6 months	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Relapse Rate, Hamilton Depression Rating Scale (17 item version)		6 months

Secondary Outcomes

Measure	Description	Time Frame
Safety and side effect scales (SWN Scale, CGI), Beck Depression Inventory		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

informed consent
age 18 - 80
diagnosis of major depression according dsm-iv, unipolar course
Hamilton-Depression-Rating-Scale (17 item score) > 18 prior to inclusion
response towards therapy with antidepressant and olanzapine as defined > 50 % reduction of HAMDD score
negative pregancy test
highly effective contraceptive method in women
no participation in other trial according to German Drug Laq
normal liver function

Exclusion Criteria:

pregnancy, lactation
depressive episode secondary to somatic disease or substance dependency
contraindication for olanzapine
treatment with interacting substances (CYP1A2 inhibitors or inductors)
comorbidity according to DSM-IV, axis I
denail of consent
hospital treatment by legal order
hepatic insufficiency
severe neurological or medical disease
adipositas permagna
HIV-infection
active viral hapatitis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ion Anghelescu, MD	Charité - University Berlin, Campus Benjamin Franklin, Department of Psychiatry and Psychotherapy	Principal Investigator
Arnim Quante, MD	Charite, University Berlin, Campus Benjamin Franklin, Department of Psychiatry and Psychotherapy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Departement of Psychiatry and Psychotherapy, Charite, University Medicine Berlin, Campus Benjamin Franklin		Berlin		14050	Germany

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D003865	Depressive Disorder, Major

Ancestor Terms

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077152	Olanzapine

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