A Phase 3 interventional study of Olanzapine and Fluoxetine in Major Depressive Disorder, sponsored by Eli Lilly and Company. Completed at 33 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2006-07-24.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
The purposes of this study are to determine:
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 600 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
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Exclusion Criteria:
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
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
(CGI-Severity of Depression), individual MADRS questions,and HAM-A item scores
Repeated measures analyses of post-baseline MADRS and HAM-A total scores
The incidence and severity of treatment-emergent adverse events and EPS. The Barnes Akathisia Scale,Simpson-Angus Scale, and the Abnormal Involuntary Movement Scale (AIMS) will be used to assess EPS
The Brief Psychiatric Rating Scale (BPRS) to evaluate the emergence of psychosis
Changes in vital signs and weight, laboratory analytes, and electrocardiograms (ECG)),Quality of life as measured by the LOCF mean change from baseline to endpoint on the Sheehan Disability Scale (SDS) score and the Short Form 36 Health Survey
Additional secondary objectives are to assess the efficacy, safety, and quality of life results of up to 8 additional weeks of open-label OFC therapy (after the treatment phase)using the following measures:
LOCF mean change from baseline to endpoint in MADRS, HAM-A, and CGI-Severity of Depression scores and study-defined rates of response and remission
Safety as measured by the incidence and severity of treatment-emergent adverse events, and EPS using the Barnes Akithisia Scale, Simpson Angus Scale and the AIM
The BPRS to examine the emergence of psychosis
Changes in vital signs and weight, laboratory analytes, and ECG
This study is completed, as verified in Jul 2006. You cannot join it, but the record below documents what was studied.
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