a study of olanzapine and fluoxetine for treatment-resistant depression

Conditions: Treatment Resistant Depression

Summary: the purpose of this study is to assess the efficacy and safety of olanzapine and fluoxetine compared to placebo and fluoxetine as treatment for treatment-resistant depression (trd) in chinese participants.


Eligibility criteria:
inclusion criteria: * have single or recurrent unipolar major depressive disorder (mdd) without psychotic features by diagnostic and statistical manual of mental disorders, fourth edition-text revision (dsm-iv-tr) clinical assessment * have a total score ≥22 on the 17-item hamilton depression rating scale (ham-d17) at screening and randomization * have treatment-resistant depression (trd), defined as having failed to achieve a satisfactory antidepressant response, in the opinion of the investigator, to separate treatment courses of at least 2 different antidepressants, other than fluoxetine, of adequate dosage and duration (≥6 weeks) within the current major depressive episode 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