Optimal Duration of Olanzapine Add-on Therapy in Major Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-04-30

Brief Summary

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

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Olanzapine 5 mg / day

Group Type ACTIVE_COMPARATOR

Olanzapine

Intervention Type DRUG

Olanzapine 5 mg / day for 6 months

2

Placebo

Group Type PLACEBO_COMPARATOR

Olanzapine

Intervention Type DRUG

Olanzapine 5 mg / day for 6 months

Interventions

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Olanzapine

Olanzapine 5 mg / day for 6 months

Intervention Type DRUG

Other Intervention Names

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EU/1/96/022/002+019

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No