Optimal Duration of Olanzapine Add-on Therapy in Major Depression

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.

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