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: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

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

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

Lead Sponsor: Charite University, Berlin, Germany

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on September 05, 2008

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