Depression, Bipolar
Conditions
Brief summary
The primary objective of this study is to assess the efficacy of olanzapine and fluoxetine combined on all the visits as compared with the baseline visit in patients with bipolar disorder, measured by the total score of the Montgomery-Asberg Depression Rating Scale (MADRS).
Interventions
DRUGOlanzapine
DRUGFluoxetine
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Meet criteria for bipolar depression, in the opinion of the investigator, according to the Diagnostic and Statistical Manual of Mental Disorders \[Text Revision\] (DSM-IV-TR) disease diagnostic criteria. * Patients must have experienced, in the opinion of the investigator, at least one previous hypomanic, manic or mixed episode as defined in DSM-IV-TR. * Subjects must have an initial score at Visit 1 of at least 20 on the MADRS.
Exclusion criteria
* Any patient currently meeting DSM-IV-TR criteria rapid-cycling course. * A CGI-Severity - Mania score of at least 3.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MADRS is a rating scale for severity of depressive mood symptoms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Global Impression - Bipolar Version (CGI-BP) Severity - Depression is used by the clinician to record the severity of depression illness at the time of assessment | — |
| CGI-BP Severity - Mania is used by the clinician to record the severity of mania illness at the time of assessment | — |
| Short Form-12 (SF-12) Questionnaire was developed from the SF-36 Health Survey for use in monitoring outcomes for general and specific populations. | — |
Countries
Puerto Rico, United States
Outcome results
None listed