TY - JOUR
T1 - Long-term safety and tolerability of open-label aripiprazole augmentation of antidepressant therapy in major depressive disorder
AU - Berman, Robert M.
AU - Thase, Michael E.
AU - Trivedi, Madhukar H.
AU - Hazel, James A.
AU - Marler, Sabrina Vogel
AU - McQuade, Robert D.
AU - Carson, William
AU - Baker, Ross A.
AU - Marcus, Ronald N.
PY - 2011
Y1 - 2011
N2 - Background: Effective management of major depressive disorder often includes the long-term use of multiple medications, and the longer-term utility and safety of adjunctive aripiprazole has not been evaluated in a controlled setting. Patients and methods: Patients (n = 706) completing one of two 14-week double-blind studies of aripiprazole augmentation, as well as de novo patients (n = 296) nonresponsive to current antidepressant therapy, were enrolled in this open-label study. Patients received openlabel aripiprazole for up to 52 weeks. Results: Open-label treatment was completed by 323 patients (32.2%). At endpoint (n = 987), the mean dose of aripiprazole was 10.1 mg/day. Common (>15% of patients) spontaneously reported adverse events were akathisia (26.2%), fatigue (18.0%), and weight gain (17.1%). The incidence of serious adverse events was 4.0%. Four spontaneous reports of possible tardive dyskinesia were submitted (0.4%); all resolved within 45 days of drug discontinuation. Mean weight change was 4.4 kg; 36.6% experienced ≥7% increase in weight from baseline (observed case analysis, n = 303). No clinically relevant changes in other metabolic parameters were seen. At the end of open-label treatment, 221 patients (69.7%) had a Clinical Global Impression- Severity of Illness score of 1 (not at all ill) or 2 (borderline ill). Conclusion: Long-term adjunctive aripiprazole therapy was well tolerated with an acceptable long-term safety and tolerability profile in patients with major depressive disorder who had not responded to treatment with one or more antidepressant therapies. Clinically significant weight gain was observed in about one-third of patients. Overall, the adverse event profile was consistent with that reported in the short-term trials and readily managed clinically.
AB - Background: Effective management of major depressive disorder often includes the long-term use of multiple medications, and the longer-term utility and safety of adjunctive aripiprazole has not been evaluated in a controlled setting. Patients and methods: Patients (n = 706) completing one of two 14-week double-blind studies of aripiprazole augmentation, as well as de novo patients (n = 296) nonresponsive to current antidepressant therapy, were enrolled in this open-label study. Patients received openlabel aripiprazole for up to 52 weeks. Results: Open-label treatment was completed by 323 patients (32.2%). At endpoint (n = 987), the mean dose of aripiprazole was 10.1 mg/day. Common (>15% of patients) spontaneously reported adverse events were akathisia (26.2%), fatigue (18.0%), and weight gain (17.1%). The incidence of serious adverse events was 4.0%. Four spontaneous reports of possible tardive dyskinesia were submitted (0.4%); all resolved within 45 days of drug discontinuation. Mean weight change was 4.4 kg; 36.6% experienced ≥7% increase in weight from baseline (observed case analysis, n = 303). No clinically relevant changes in other metabolic parameters were seen. At the end of open-label treatment, 221 patients (69.7%) had a Clinical Global Impression- Severity of Illness score of 1 (not at all ill) or 2 (borderline ill). Conclusion: Long-term adjunctive aripiprazole therapy was well tolerated with an acceptable long-term safety and tolerability profile in patients with major depressive disorder who had not responded to treatment with one or more antidepressant therapies. Clinically significant weight gain was observed in about one-third of patients. Overall, the adverse event profile was consistent with that reported in the short-term trials and readily managed clinically.
KW - Adjunctive aripiprazole
KW - Antidepressant therapy
KW - Longterm safety and tolerability
KW - Major depressive disorder
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U2 - 10.2147/NDT.S18333
DO - 10.2147/NDT.S18333
M3 - Article
C2 - 21655344
AN - SCOPUS:80053626849
SN - 1176-6328
VL - 7
SP - 303
EP - 312
JO - Neuropsychiatric Disease and Treatment
JF - Neuropsychiatric Disease and Treatment
IS - 1
ER -