Optimal Duration of Olanzapine Add-on Therapy in Major Depression

Relapse Rate of a Major Depressive Episode Clinical Trial

— OLA-D  

Official title:

Optimal Duration of Olanzapine Add-on Therapy in Major Depression: a Placebo-controlled, Randomized, Phase III, Pilot Study in Parallel Group Design

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00568672
• Other study ID #: 2007-000512-82
• Status: Withdrawn
• Phase: Phase 3
• Start date: October 2007
• Est. completion date: April 2008

Study information

• Verified date: February 2023
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Olanzapine
Olanzapine 5 mg / day for 6 months

Locations

Country	Name	City	State
Germany	Departement of Psychiatry and Psychotherapy, Charite, University Medicine Berlin, Campus Benjamin Franklin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Eli Lilly and Company

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse Rate, Hamilton Depression Rating Scale (17 item version)		6 months
Secondary	Safety and side effect scales (SWN Scale, CGI), Beck Depression Inventory		6 months

External Links

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