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

Eli Lilly and Company600 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

600

Conditions

Major Depressive Disorder

Interventions

OlanzapineDRUG

FluoxetineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Locations (33)

Outcomes

Primary Outcomes

To assess the efficacy of up to 8 weeks of treatment with OFC versus olanzapine and fluoxetine monotherapies, in patients with recurrent MDD without psychotic features

who meet study criteria for TRD, as measured by last observation carried forward (LOCF) mean change from baseline to endpoint in the MADRS total score

Treatment-resistant depression will be defined as:historic failure to achieve satisfactory response to an antidepressant (other than fluoxetine) during the current MDD episode

when treated with an acceptable antidepressant drug and dose for at least 6 weeks

prospective failure to achieve a satisfactory response to fluoxetine monotherapy during the 8 week study lead-in phase

Secondary Outcomes

To compare the efficacy, safety, and quality of life results of up to 8 weeks of OFC therapy(treatment phase) with fluoxetine and olanzapine monotherapies using the following assessments:

Onset of action as measured by time to achieve and initial response (greater than or equal to 25% reduction from baseline in MADRS total score

Efficacy in the treatment of co-morbid anxiety symptoms as measured by LOCF mean change from baseline to endpoint in Hamilton Psychiatric Rating Scale for Anxiety (HAM-A)total score

Study-defined response and remission rates including time to achieve a full response (defined as greater than or equal to 50% reduction in MADRS total score)

and time to achieve remission (defined as MADRS total score less than or equal to 10 at endpoint)

LOCF mean change from baseline to endpoint in Clinical Global Impression - Severity of Depression score

Data from ClinicalTrials.gov

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Oceanside, California, United States

San Marcos, California, United States

Torrance, California, United States

New London, Connecticut, United States

Coral Springs, Florida, United States

North Miami, Florida, United States

St. Petersburg, Florida, United States

Atlanta, Georgia, United States

Marietta, Georgia, United States

Chicago, Illinois, United States

...and 23 more locations