A Study of Olanzapine and Fluoxetine for Treatment-resistant Depression

Exclusion Criteria

• •Have a diagnosis of Parkinson's disease or a related disorder
• •Have a current or lifetime diagnosis of any of the following conditions, according to DSM-IV-TR criteria: Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorder; Delusional Disorder; Psychotic Disorder Not Otherwise Specified; Bipolar Disorder I or II; Delirium of any type; Dementia of any type; Amnestic Disorder; any Substance-Induced Disorder; or any Psychotic Disorder due to a General Medical Condition
• •Have a current diagnosis of post-partum depression or MDD with a seasonal pattern as defined in the DSM-IV-TR
• •Have paranoid, schizoid, schizotypal, antisocial, or borderline personality disorder (Axis II) as a comorbid or primary diagnosis, based on DSM-IV-TR criteria
• •Have DSM-IV-TR substance dependence/abuse or are not willing to avoid use of the substance (not including dependence on nicotine or caffeine) within 30 days of screening
• •Are actively suicidal in the judgment of the investigator
• •Have uncorrected narrow-angle glaucoma
• •Have had one or more seizures without a clear and resolved etiology
• •Have leukopenia
• •Have any acute, serious, or unstable medical conditions
• •Have an increased serum prolactin concentration at screening
• •Have a rate-corrected cardiac QT interval, calculated using Bazett's formula (QTc Bazett's \[Rate-corrected cardiac QT interval on electrocardiogram calculated using Bazett's formula(QTcB)\]), on Electrocardiogram (ECG) \>450 milliseconds (male) or \>470 milliseconds (female) at screening
• •Have a history of allergic reaction to olanzapine, fluoxetine, or olanzapine in combination with fluoxetine
• •Have had treatment with olanzapine, fluoxetine, or olanzapine in combination with fluoxetine withdrawn due to clinically significant and/or intolerable adverse effects within 6 months of screening
• •Have received treatment with remoxipride within 6 months of randomization
• •Have received treatment with depot antipsychotics within one dosing interval before randomization
• •Have received electroconvulsive therapy (ECT) or vagus nerve stimulation (VNS) treatment within the current MDD episode, or has a history of failure to respond to adequate treatment courses of ECT or VNS, or is expected to require ECT or VNS at any time during the study
• •Have received previous treatment with clozapine
• •Have received treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of screening, or are expected to need MAOI treatment at any time during the study or up until 5 weeks after study discontinuation