Clinical Methodology Sample Clauses

Clinical Methodology. The dataset used for this thesis, the REVAMP trial, was conducted between 2002 and 2006. The REVAMP trial had two twelve-week phases. Throughout the first phase, patients received antidepressant medication based on the pharmacotherapy algorithm. Response was evaluated throughout this phase and it was determined if the patient was a remitter, partial responder (PR), or non-responder (NR). Patients who achieved less than remission (NR, PR) were randomized into phase two. Remission criterion are met when the patient no longer meets the DSM-IV criteria for major depressive disorder for two consecutive visits occurring within weeks six through twelve, has a 24-item HAM-D total score less than eight, and has a greater than sixty percent reduction in their HAM-D total score. Throughout phase two, all subjects (patients who did not show full response in phase one) received the next step treatment in the pharmacotherapy algorithm. Along with an augmentation to their medication, they were randomized into one of the three treatment cells in a 2:2:1 ratio. The first treatment group had CBASP added along with their medication. The second treatment group had BSP added along with their medication. The third treatment group continued taking medication alone. The REVAMP trial was based at eight academic centers; patients were recruited through advertising and clinicians. To be included in the study, patients had to have depressive symptoms for more than two years without remission and a current major depression episode, defined by DSM-IV, for at least four weeks. Patients were between 18 and 75 years old, had scored at least 20 on the 24-item HAM-D at baseline, understood the requirements of the study, fluently spoke and understood English, and signed the informed consent. The response algorithm used in this study was based on empirically created algorithms such as the Texas Medication Project (Xxxxxxx, et al., 1999) and other expert approaches (Thase & Rush, When at first you don't succeed: sequential strategies for antidepressant nonresponders, 1997; Rush & Thase, Strategies and tactics in the treatment of chronic depression, 1997; Depression Guideline Panel, 1993; American Psychiatric Association, 2000). This algorithm was closely related to the algorithms used in the STAR*D study (Fava, et al., 2003). The sequence included sertraline hydrochloride and escitalopram oxalate, two selective serotonin reuptake inhibitors (SSRIs), and newer substitutes to SSRIs such as venla...
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