A Study in Relapse Prevention of Treatment-resistant Depression



Status:Archived
Conditions:Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:August 2009
End Date:July 2014

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A Study to Assess the Long-Term Efficacy and Safety of Olanzapine and Fluoxetine Combination Versus Fluoxetine Only in the Relapse Prevention of Stabilized Patients With Treatment-Resistant Depression


The purpose of this study is to determine whether olanzapine and fluoxetine combination
(OFC) if used for a long time (47 weeks) makes patients suffering from Treatment Resistant
Depression stable, determine if OFC is safe when used to treat patients with Treatment
Resistant Depression for a long time (up to 47 weeks), to determine whether olanzapine and
fluoxetine combination or fluoxetine alone is better to treat Treatment Resistant Depression
when treated for a long time ( up to 47 weeks) and to assess the quality of life during
treatment.


This is a multicenter, randomized, double-blind, active comparator-controlled, parallel
study of patients with Treatment Resistant Depression (TRD), comparing the efficacy and
safety of olanzapine and fluoxetine Combination (OFC) versus fluoxetine in relapse
prevention of stabilized patients with TRD. The study will consist of 4 phases: a screening
phase; a 6- to 8-week open-label acute treatment phase; a 10- to 12-week open-label
stabilization phase; and a 27- to 29-week double-blind relapse prevention treatment phase.
Patients who demonstrate response to open-label OFC during the acute treatment phase will
continue into the stabilization phase. Patients who remain stable while receiving open-label
OFC during this phase will be randomized to receive either OFC or fluoxetine during the
double-blind relapse prevention phase. Investigators and patients will be blinded to the
precise duration of the stabilization period, the definition of remission, and the criteria
for entry into the relapse prevention phase; this information is described in a supplement
given to Ethical Review Boards (ERBs) and regulatory authorities.


We found this trial at
19
sites
1 South Prospect Street
Burlington, Vermont 05401
802-656-8990
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100 Campus Dr # 108
Scarborough, Maine 04074
(207) 396-7600
Maine Center for Cancer Medicine and Blood Disorders - Scarborough Maine Center for Cancer Medicine...
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Scarborough, ME
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Bethesda, MD
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Boston, Massachusetts 02115
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Boston, MA
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Boston, MA
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Bridgewater, NJ
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506 6th St
Brooklyn, New York 11215
(718) 780-3000
New York Methodist Hospital A voluntary, acute-care teaching hospital, New York Methodist Hospital's mission is...
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Brooklyn, NY
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Burlington, VT
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Burlington, Wisconsin 53105
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Burlington, WI
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Burlington, WI
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Cincinnati, OH
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Fort Worth, TX
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Hartford, CT
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Hartford, Connecticut 06106
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Hartford, CT
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Hazard, KY
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Nashua, NH
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Seattle, WA
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Washington, Washington DC 20422
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Washington, DC
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