Optimal Duration of Olanzapine Add-on Therapy in Major Depression

Charite University, Berlin, Germany

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Relapse Rate of a Major Depressive Episode Safety of Olanzapine in Subjects With Major Depression

Interventions

OlanzapineDRUG

Olanzapine 5 mg / day for 6 months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Departement of Psychiatry and Psychotherapy, Charite, University Medicine Berlin, Campus Benjamin Franklin

Berlin, Germany

Outcomes

Primary Outcomes

Relapse Rate, Hamilton Depression Rating Scale (17 item version)

Time frame: 6 months

Secondary Outcomes

Safety and side effect scales (SWN Scale, CGI), Beck Depression Inventory

Time frame: 6 months

Data from ClinicalTrials.gov

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