Side effects were also examined via the UKU side effects scale.103 Overall UKU scores showed a decline (indicating fewer reports of Angiogenesis inhibitor somatic complaints compared to baseline). However, the mean score of the UKU-Neurologic subscalc increased. Six of 24 (25%) subjects had a positive score on the UKU-akathisia item on at least one time point; however, in all but. one case, these were mild Inhibitors,research,lifescience,medical and/or transient. We also examined metabolic changes and weight gain during the 12-week period of pharmacotherapy augmentation. One subject had a significant increase in lipids, and none had a significant

increase in blood sugar, suggesting that metabolic effects were infrequent with aripiprazole. Weight gain was highly variable: 9/15 (60%) gained

<2 kg (mean [range] 0.8 [-0.7- 1.8]) while 6/15 (40%) gained >3 kg (mean Inhibitors,research,lifescience,medical [range] 4.7 [3.2-6.4]), suggesting that an examination of sources of weight gain variability would be useful. Two possibilities from the literature are genetic variation at. the 5-HT2C receptor (posited as the receptor responsible for weight gain with aripiprazole) and baseline body mass index (BMI). Also, we were not. able to determine whether weight gain represented Inhibitors,research,lifescience,medical an increase in adiposity vs an increase in lean body mass with remission from depression. Thus, we determined that a controlled study should include: (i) a more precise examination of changes in adiposity, including DEXA scans which would provide quantitative measures of body fat; (ii) an examination of moderators of weight gain (including baseline BMI and 5-HT2C genotyping); and (iii) a continuation phase, allowing longer duration to observe weight, changes. Pilot study of continuation phase pharmacotherapy Inhibitors,research,lifescience,medical Of the 24 participants who received acute-phase adjunctive aripiprazole, 12 met study criteria for complete response (remission) and entered continuation phase pharmacotherapy, on an average daily dose of 10 mg of aripiprazole (as an adjunct to their primary antidepressant, pharmacotherapy). The 12 participants in the feasibility study of continuation-phase Inhibitors,research,lifescience,medical pharmacotherapy had a mean age of 72.7 (SD:

6.2); 9 were women, and 10 were white (2 were African-American). Outcomes Depressive relapse during continuation-phase pharmacotherapy Over a median duration of 27.6 weeks (range: 2-106) of continuation-phase combined pharmacotherapy (antidepressant. + aripiprazole), and none of the 12 participants experienced relapse of a major depressive episode. Retention One of 12 participants was noncompliant with study procedure (due to respondent burden and other treatment preferences) and exited the study. Side effects UKU side effect, scores remained stable (9.4[3.2] at start of continuation-phase pharmacotherapy [n = 12] and 7.9[2.8] at. 6 months [n = 7]). No participant left the study due to treatment-emergent adverse events.