The Study of Olanzapine Plus Fluoxetine in Combination for Treatment of Treatment Resistant Depression
NCT ID: NCT00035321
Last Updated: 2006-07-24
Study Results
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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COMPLETED
PHASE3
600 participants
INTERVENTIONAL
2002-04-30
2005-07-31
Brief Summary
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* 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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Olanzapine
Fluoxetine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
65 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
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San Marcos, California, United States
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Torrance, California, United States
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New London, Connecticut, United States
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Coral Springs, Florida, United States
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North Miami, Florida, United States
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St. Petersburg, Florida, United States
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Atlanta, Georgia, United States
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Marietta, Georgia, United States
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Chicago, Illinois, United States
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Libertyville, Illinois, United States
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Oak Brook, Illinois, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Glen Burnie, Maryland, United States
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Westminster, Maryland, United States
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Pittsfield, Massachusetts, United States
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Columbia, Missouri, United States
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Clementon, New Jersey, United States
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Moorestown, New Jersey, United States
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Toms River, New Jersey, United States
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Dayton, Ohio, United States
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Medford, Oregon, United States
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Salem, Oregon, United States
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Sellersville, Pennsylvania, United States
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Lincoln, Rhode Island, United States
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Dallas, Texas, United States
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Salt Lake City, Utah, United States
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Richmond, Virginia, United States
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Waukesha, Wisconsin, United States
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St. John's, Newfoundland and Labrador, Canada
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Kingston, Ontario, Canada
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St. John's, , Canada
Countries
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References
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Houston JP, Kohler J, Bishop JR, Ellingrod VL, Ostbye KM, Zhao F, Conley RR, Poole Hoffmann V, Fijal BA. Pharmacogenomic associations with weight gain in olanzapine treatment of patients without schizophrenia. J Clin Psychiatry. 2012 Aug;73(8):1077-86. doi: 10.4088/JCP.11m06916.
Houston JP, Lau K, Aris V, Liu W, Fijal BA, Heinloth AN, Perlis RH. Association of common variations in the norepinephrine transporter gene with response to olanzapine-fluoxetine combination versus continued-fluoxetine treatment in patients with treatment-resistant depression: a candidate gene analysis. J Clin Psychiatry. 2012 Jun;73(6):878-85. doi: 10.4088/JCP.10m06744. Epub 2012 Mar 6.
Houston J, Dharia S, Bishop JR, Ellingrod VL, Fijal B, Jacobson JG, Hoffmann VP. Association of DRD2 and ANKK1 polymorphisms with prolactin increase in olanzapine-treated women. Psychiatry Res. 2011 May 15;187(1-2):74-9. doi: 10.1016/j.psychres.2010.10.020. Epub 2010 Nov 20.
Tohen M, Case M, Trivedi MH, Thase ME, Burke SJ, Durell TM. Olanzapine/fluoxetine combination in patients with treatment-resistant depression: rapid onset of therapeutic response and its predictive value for subsequent overall response in a pooled analysis of 5 studies. J Clin Psychiatry. 2010 Apr;71(4):451-62. doi: 10.4088/JCP.08m04984gre. Epub 2010 Feb 23.
Thase ME, Corya SA, Osuntokun O, Case M, Henley DB, Sanger TM, Watson SB, Dube S. A randomized, double-blind comparison of olanzapine/fluoxetine combination, olanzapine, and fluoxetine in treatment-resistant major depressive disorder. J Clin Psychiatry. 2007 Feb;68(2):224-36. doi: 10.4088/jcp.v68n0207.
Other Identifiers
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H6P-MC-HDAO
Identifier Type: -
Identifier Source: secondary_id
6272
Identifier Type: -
Identifier Source: org_study_id