Optimal Duration of Olanzapine Add-on Therapy in Major Depression

Verified by: Charite University, Berlin, Germany, April 2008
First Received: December 5, 2007 | Last Updated: April 23, 2008 | Phase: Phase 3 | Start Date: October 2007
Overall Status: Withdrawn | Estimated Enrollment: 30
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Evaluation of olanzapine versus placebo in the continuation therapy of subjects with major depression who had a response with additional olanzapine to an antidepressant...

Brief Summary

Official Title: “Optimal Duration of Olanzapine Add-on Therapy in Major Depression: a Placebo-Controlled, Randomized, Phase III, Pilot Study in Parallel Group Design”

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

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: 1
    • Olanzapine 5 mg / day
  • Placebo Comparator: 2
    • Placebo

Outcome Measures for this Clinical Trial

Primary Measures

  • Relapse Rate, Hamilton Depression Rating Scale (17 item version)
    • Time Frame: 6 months
      Safety Issue?: Yes

Secondary Measures

  • Safety and side effect scales (SWN Scale, CGI), Beck Depression Inventory
    • Time Frame: 6 months
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Charite University, Berlin, Germany Other

Overall Clinical Trial Officials and Contacts

Ion Anghelescu, MD Principal Investigator Charité - University Berlin, Campus Benjamin Franklin, Department of Psychiatry and Psychotherapy  

Additional Information

Information obtained from ClinicalTrials.gov on February 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00568672

Study ID Number: 2007-000512-82

ClinicalTrials.gov Identifier: NCT00568672

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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