The Study of Olanzapine Plus Fluoxetine in Combination for Treatment of Treatment Resistant Depression

Lilly

Status and phase

Completed

Phase 3

Conditions

Major Depressive Disorder

Treatments

Drug: Fluoxetine

Drug: Olanzapine

Study type

Interventional

Funder types

Industry

Identifiers

H6P-MC-HDAO

6272

Details and patient eligibility

About

The purposes of this study are to determine:

Whether olanzapine plus fluoxetine in combination will help patients with treatment-resistant major depression.
The safety of olanzapine plus fluoxetine in combination, plus and any side effects that might be associated with the combination.
The effectiveness of olanzapine plus fluoxetine compared to olanzapine and fluoxetine alone.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female patients, 18 - 65 years of age.
Each patient must have a level of understanding sufficient to perform all tests and examinations required by the protocol, and must be considered reliable according to the investigator's clinical judgement
Patients must fulfill the criteria for recurrent MDD without psychotic features as defined by the DSM-IV, based on clinical assessment and confirmed by Structured Clinical Interview for DSM-IV Axis I Disorders - Clinical Version (SCID-I) plus the Major Depressive Disorder Specifiers included in the Research Version of the SCID-I. This includes at least one of the following diagnoses: 296.31, 296.32, and 296.33
Female patients of childbearing potential must be using a medically accepted means of contraception throughout the course of the study. Use of any oral or injectable contraception must be initiated prior to visit 2
Failure to achieve satisfactory antidepressant response to an adequate trial of an antidepressant (except fluoxetine), for at least 6 weeks at an acceptable dose or greater, occurring within the current episode of MDD

Exclusion criteria

Treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry
Exposure to OFC in a Lilly-sponsored clinical trial investigating OFC, and any patients historically failing to respond to olanzapine and fluoxetine in combination under any circumstance
Persons who have previously entered any Lilly-sponsored study which was investigating olanzapine
Female patients who are either pregnant or nursing
Serious, unstable illnesses for which death is anticipated within 1 year of intensive care unit hospitalization for the disease is anticipated within 6 months. This includes hepatic (specifically any degree of jaundice), renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic diseases (specifically current agranulocytosis with an absolute neutrophil count < 500 mm_3)