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J Clin Psychiatry. <https://www.ncbi.nlm.nih.gov/pubmed/17335320#> 2007
Feb;68(2):224-36.
A randomized, double-blind comparison of olanzapine/fluoxetine combination,
olanzapine, and fluoxetine in treatment-resistant major depressive disorder.
Thase ME
<https://www.ncbi.nlm.nih.gov/pubmed/?term=Thase%20ME%5BAuthor%5D&cauthor=true&cauthor_uid=17335320>
1, Corya SA
<https://www.ncbi.nlm.nih.gov/pubmed/?term=Corya%20SA%5BAuthor%5D&cauthor=true&cauthor_uid=17335320>,
Osuntokun O
<https://www.ncbi.nlm.nih.gov/pubmed/?term=Osuntokun%20O%5BAuthor%5D&cauthor=true&cauthor_uid=17335320>,
Case M
<https://www.ncbi.nlm.nih.gov/pubmed/?term=Case%20M%5BAuthor%5D&cauthor=true&cauthor_uid=17335320>,
Henley DB
<https://www.ncbi.nlm.nih.gov/pubmed/?term=Henley%20DB%5BAuthor%5D&cauthor=true&cauthor_uid=17335320>,
Sanger TM
<https://www.ncbi.nlm.nih.gov/pubmed/?term=Sanger%20TM%5BAuthor%5D&cauthor=true&cauthor_uid=17335320>,
Watson SB
<https://www.ncbi.nlm.nih.gov/pubmed/?term=Watson%20SB%5BAuthor%5D&cauthor=true&cauthor_uid=17335320>,
Dubé S
<https://www.ncbi.nlm.nih.gov/pubmed/?term=Dub%C3%A9%20S%5BAuthor%5D&cauthor=true&cauthor_uid=17335320>
.
Author information <https://www.ncbi.nlm.nih.gov/pubmed/17335320#>
Abstract
OBJECTIVE:

Two parallel, 8-week double-blind studies compared olanzapine/fluoxetine
combination, olanzapine, and fluoxetine in outpatients with
treatment-resistant depression (TRD).
METHOD:

Treatment-resistant depression was defined as a documented history of
current-episode antidepressant failure plus a prospective failure on
fluoxetine. Following an 8-week fluoxetine lead-in, 605 nonresponders with
DSM-IV major depressive disorder were randomly assigned to
olanzapine/fluoxetine combination, olanzapine, or fluoxetine. The primary
outcome measure was baseline-to-endpoint mean change on the
Montgomery-Asberg Depression Rating Scale (MADRS). The study was conducted
from April 2002 to May 2005.
RESULTS:

After 8 weeks of double-blind treatment, Study 1 revealed no statistically
significant therapy differences in MADRS mean change (olanzapine/fluoxetine
combination: -11.0, fluoxetine: -9.4, olanzapine: -10.5). In Study 2,
olanzapine/fluoxetine combination demonstrated significantly greater MADRS
improvement (-14.5) than fluoxetine (-8.6, p < .001) and olanzapine (-7.0,
p < .001). Pooled study results revealed significant differences for
olanzapine/ fluoxetine combination (-12.7) versus fluoxetine (-9.0, p <
.001) and olanzapine (-8.8, p < .001). Pooled remission rates were 27% for
olanzapine/ fluoxetine combination, 17% for fluoxetine, and 15% for
olanzapine. Adverse events were consistent with previous studies.
Cholesterol mean change (mg/dL) was +15.1 for olanzapine/ fluoxetine
combination, +0.8 for fluoxetine, and +2.7 for olanzapine. Mean weight
change (kg) was +4.9 for olanzapine/fluoxetine combination, +0.4 for
fluoxetine, and +5.5 for olanzapine. Nonfasting glucose mean change (mg/dL)
was +11.4 for olanzapine/fluoxetine combination, +4.9 for fluoxetine, and
+9.9 for olanzapine.
CONCLUSION:

Patients with TRD (defined as treatment failure on 2 antidepressants)
taking olanzapine/fluoxetine combination demonstrated significantly greater
improvement in depressive symptoms than patients taking olanzapine or
fluoxetine in 1 of 2 studies and in the pooled analysis. When considered
within the context of all available evidence, olanzapine/fluoxetine
combination is an efficacious therapy for patients with TRD.
CLINICAL TRIALS REGISTRATION:

ClinicalTrials.gov identifier: NCT00035321
<http://clinicaltrials.gov/show/NCT00035321>.
PMID: 17335320
[Indexed for MEDLINE]


GERARDO GUTIERREZ

MEDICAL LIBRARIAN

EDUFARM