Optimal Duration of Olanzapine Add-on Therapy in Major Depression (OLA-D)

Charité University Medicine Berlin

Status and phase: Withdrawn; Phase 3

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

Treatments: Drug: Olanzapine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00568672

2007-000512-82

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Olanzapine 5 mg / day

Treatment:

Drug: Olanzapine

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Olanzapine