Optimal Duration of Olanzapine Add-on Therapy in Major Depression

Phase 3

Withdrawn

• Conditions: Relapse Rate of a Major Depressive Episode; Safety of Olanzapine in Subjects With Major Depression
• Interventions: Drug: Olanzapine

• Registration Number: NCT00568672
• Lead Sponsor: Charite University, Berlin, Germany

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 available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-12-05
• Study First Submitted QC: 2007-12-05
• Study First Posted: 2007-12-06
• Primary Completion: 2008-01
• Study Completion: 2008-04
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Olanzapine	Olanzapine 5 mg / day
2	Olanzapine	Placebo

Primary Outcome Measures

Name	Time	Method
Relapse Rate, Hamilton Depression Rating Scale (17 item version)	6 months

Secondary Outcome Measures

Name	Time	Method
Safety and side effect scales (SWN Scale, CGI), Beck Depression Inventory	6 months

Trial Locations

Locations (1)

Departement of Psychiatry and Psychotherapy, Charite, University Medicine Berlin, Campus Benjamin Franklin; 🇩🇪 Berlin, Germany