Optimal Duration of Olanzapine Add-on Therapy in Major Depression

• Status: Withdrawn
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Collaborator: Eli Lilly and Company
• Treatments: Olanzapine

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