In most subjects who remitted, the improvements in depression were stable throughout 6-month continuation pharmacotherapy. Aripiprazole was well-tolerated, with a low rate of dropout due to side effects and a high completion rate, but restlessness and weight gain were not uncommon. Overall, a larger, placebo-controlled Inhibitors,research,lifescience,medical study is needed to test hypotheses related to remission,
tolerability, safety, and outcome predictors. These pilot data support the feasibility of such a trial. In Figure 2, we show the design of a placebo-controlled randomized clinical trial which we plan to conduct. Figure 2. Representation of proposed multisite study of Inhibitors,research,lifescience,medical aripiprazoie (aripip) augmentation for treatment-resistant late-life depression. Venla, venlafaxine The planned trial calls for enrolling 500 patients aged 60 and older with major depressive disorder and treating them openly for 12 weeks with venlafaxine XR (up to 225 mg/d) to prospectively determine incomplete response (phase 1). Participants meeting criteria for incomplete response estimated (n=200) will be randomly assigned to receive either Inhibitors,research,lifescience,medical aripiprazoie (2.5-15 mg/d; target dose: 10 mg/d) or placebo augmentation of venlafaxine for 12 weeks (phase 2), with the
goal of achieving remission (Montgomery-Åsberg DRS<10 for two consecutive assessments). Those who remit in phase 2 will receive continuation treatment, with the same doubleblinded intervention to which they were randomly assigned (phase 3), for 12 weeks to determine the stability Inhibitors,research,lifescience,medical of remission. Based on efficacy and tolerability data, we will estimate number needed to treat and number needed to harm, providing a clinically informative estimate of benefits Inhibitors,research,lifescience,medical and risks of aripiprazoie augmentation for TRLLD. Conclusion In summary, the public health
importance of TRLLD studies is great, but. there are no data from controlled studies to guide practice. Data are needed to not only examine the overall efficacy of adjunctive treatments but also examine second in whom such treatments are most, efficacious and safe, thus moving the treatment of LLD into the arena of personalized medicine. Acknowledgments P30 MH07 1944, R37 MH43832, R01 MH3786769, T32 MH19986, RR 024153, and the John A. Hartford Foundation Center of Excellence in Geriatric Psychiatry Selected abbreviations and acronyms LLD late-life depression SRNI serotonin/norepinephrine reuptake inhibitor SSRI AVL-301 supplier selective serotonin reuptake inhibitor TRD treatment-resistant depression TRLLD treatment-resistant late-life depression
Geriatric depression is a clinically and neurobiologically heterogeneous disorder.