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Long-term safety and tolerability of open-label aripiprazole augmentation of antidepressant therapy in major depressive disorder.

Berman RM, Thase ME, Trivedi MH, Hazel JA, Marler SV, McQuade RD, Carson W, Baker RA, Marcus RN - Neuropsychiatr Dis Treat (2011)

Bottom Line: 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%.Clinically significant weight gain was observed in about one-third of patients.

View Article: PubMed Central - PubMed

Affiliation: Neuroscience Global Clinical Research Bristol-Myers Squibb, Wallingford, CT, USA;

ABSTRACT

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 open-label 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.

No MeSH data available.


Related in: MedlinePlus

Enrollment, randomization, and disposition of patients.Notes: Shaded boxes represent first aripiprazole dosing; aPatients in Phase B+ were antidepressant therapy responders at week 8 who received placebo for an additional six weeks.
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f1-ndt-7-303: Enrollment, randomization, and disposition of patients.Notes: Shaded boxes represent first aripiprazole dosing; aPatients in Phase B+ were antidepressant therapy responders at week 8 who received placebo for an additional six weeks.

Mentions: In total, 1076 patients (rollover, n = 706; de novo, n = 370) provided informed consent for study participation, of whom 1002 entered the open-label treatment phase (rollover, n = 706; de novo, n = 296). Patient disposition is shown in Figure 1 and the characteristics of patients included in the safety analyses are shown in Table 1. In total, 323 patients (32.2%) completed 52 weeks of open-label treatment; completion rates were similar between the rollover and de novo groups (Figure 1). Overall, the most common reasons for withdrawal from the open-label treatment phase were adverse events (23.0%), lack of efficacy/relapse (13.5%), and withdrawal of consent (12.5%). Time to discontinuation of aripiprazole due to any reason during open-label treatment is shown in Figure 2.


Long-term safety and tolerability of open-label aripiprazole augmentation of antidepressant therapy in major depressive disorder.

Berman RM, Thase ME, Trivedi MH, Hazel JA, Marler SV, McQuade RD, Carson W, Baker RA, Marcus RN - Neuropsychiatr Dis Treat (2011)

Enrollment, randomization, and disposition of patients.Notes: Shaded boxes represent first aripiprazole dosing; aPatients in Phase B+ were antidepressant therapy responders at week 8 who received placebo for an additional six weeks.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3104689&req=5

f1-ndt-7-303: Enrollment, randomization, and disposition of patients.Notes: Shaded boxes represent first aripiprazole dosing; aPatients in Phase B+ were antidepressant therapy responders at week 8 who received placebo for an additional six weeks.
Mentions: In total, 1076 patients (rollover, n = 706; de novo, n = 370) provided informed consent for study participation, of whom 1002 entered the open-label treatment phase (rollover, n = 706; de novo, n = 296). Patient disposition is shown in Figure 1 and the characteristics of patients included in the safety analyses are shown in Table 1. In total, 323 patients (32.2%) completed 52 weeks of open-label treatment; completion rates were similar between the rollover and de novo groups (Figure 1). Overall, the most common reasons for withdrawal from the open-label treatment phase were adverse events (23.0%), lack of efficacy/relapse (13.5%), and withdrawal of consent (12.5%). Time to discontinuation of aripiprazole due to any reason during open-label treatment is shown in Figure 2.

Bottom Line: 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%.Clinically significant weight gain was observed in about one-third of patients.

View Article: PubMed Central - PubMed

Affiliation: Neuroscience Global Clinical Research Bristol-Myers Squibb, Wallingford, CT, USA;

ABSTRACT

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 open-label 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.

No MeSH data available.


Related in: MedlinePlus