of this study were to Dabigatran determine the extent and time course of antidepressant improvement to a single intravenous dose of ketamine in patients with TRD, and to determine whether the addition of riluzole would have an additional benefit in improving depressive symptoms. Partial results from the pre randomization phase were previously published. MATERIALS AND METHODS Patient Selection Subjects were recruited from physician referrals throughout the United States and from local inpatient psychiatric units, as well as through advertisements in local newspapers and on the internet. Men and women aged 18 65 years were eligible to participate if they had a diagnosis of recurrent major depressive disorder without psychotic features, as diagnosed using the Structured Clinical Interview for Axis I DSM IV DisordersFPatient Version.
Patients with a history of antidepressant or substanceinduced hypomania or mania were excluded. All subjects were studied at the Clinical Research Center of the National Institute of Lenalidomide Revlimid Mental Health in Bethesda, Maryland between January 2006 and September 2010. Subjects were required to have a score of X22 on the Montgomery Asberg Depression Rating Scale at screening and on the day of ketamine infusion, with no greater than a 25% decrease in MADRS total score between these two time points. Furthermore, patients had to have previously failed at least two adequate antidepressant trials, and currently be experiencing a major depressive episode of at least 4 weeks duration.
All subjects were in good physical health as determined by medical history, physical examination, blood labs, electrocardiogram, Voriconazole P450 inhibitor chest X ray, urinalysis, and toxicology screen. Subjects were free of comorbid substance abuse or dependence for at least 3 months and had a negative urine toxic screen on admission. Comorbid axis I anxiety disorder diagnoses were permitted if they were not the primary focus of treatment within 12 months before screening. Exclusion criteria included any serious unstable medical disorder or condition, previous use of ketamine, riluzole, phencyclidine, or concomitant treatment with psychotropic medications or ECT in the 2 weeks prior to ketamine infusion, in addition, female subjects could not be pregnant or nursing. The study was approved by the Combined Neuroscience Institutional Review Board of the National Institutes of Health.
All subjects Dasatinib Bcr-Abl inhibitor provided written informed consent language before entry into the study and were assigned a clinical research advocate from the NIMH Human Subjects Protection Unit to monitor the consent process and research participation throughout the study. Sample Size The study was designed to detect a moderate to large difference. between ketamine plus riluzole vs ketamine plus placebo, so a minimum of 34 patients were expected per group to achieve 80% power with Po0.05, two tailed. However, the protocol stipulated an interim analysis after approximately 60% of the data were collected to check safety measures and efficacy assumptions. The results of that interim analysis are reported here. Study Design and Medications This was a double blind, randomized, parallel, placebocontrolled, flexible dose inpatient study conducted to assess two measures: first, the efficacy and safety of the addition.