Adjunctive Brexpiprazole May Improve Anger, Irritability in MDD Patients
Irritability and anger symptoms for patients with major depressive disorder (MDD) may be improved with adjunctive brexpiprazole treatment. Those are the findings of a new, 8-week, open label study conducted at 15 sites across the United States between October 2013 and July 2014.
In total, 54 patients matched the criteria for study inclusion; by being diagnosed with MDD according to DSM-IV-TR criteria and having their current major depressive episode (MDE) confirmed using the Mini International Neuropsychiatric Interview.
The study included a 6-week period of open-label treatment with the patient's current antidepressant and adjunctive treatment with brexpiprazole. After the 6 weeks patients discontinued the brexpiprazole treatment while continuing their regular antidepressant, and had a 4-week follow-up period.
Throughout, treatment with the regular antidepressant remained the same, while brexpiprazole was titrated up from 1mg once daily for 1 week, followed by 2mg once daily for 1 week and increased to the target dose of 3mg once daily for 4 weeks.
Changes in levels of irritability, were measured using the Sheehan Irritability Scale, Sheehan Irritability Scale item 1, and IDS-C item 6; the Monetary Choice Questionnaire and Barratt Impulsiveness Scale, version 11 were used to measure impulsivity; while the Kellner Symptom Questionnaire and Anger Attacks Questionnaire were used to measure anger and hostility.
Results showed that irritability symptoms had improved by week 6 with brexpiprazole treatment. Sheehan Irritability Scale scores decreased from baseline, with a mean change of –21.1 (95%CI, –26.3 to –16.0), mean Sheehan Irritability Scale item 1 score decreased to –3.5 (95% CI, –4.2 to –2.7), and mean IDS-C item 6 score decreased –1.2 (95% CI, –1.5 to –1.0).
No change was noted in the Monetary Choice Questionnaire during the first 6 weeks of treatment with adjunctive brexpiprazole, although symptoms worsened when brexpiprazole was discontinued. At week 6 the average Kellner Symptom Questionnaire anger-hostility scores improved by 7.7 points (95% –9.6 to –5.9). At week 10 – after discontinuation of brexpiprazole – the mean score change was 1.2 points (95% CI, –0.8 to 3.2), which indicated no further improvements once patients stopped taking brexpiprazole.
In addition to improvements in irritability and anger issues, a number of barometers also showed a consistent improvement in the severity of depressive symptoms. At week 6 there was a decrease from baseline in mean IDS-C score of –17.8 (95% CI, –21.0 to –14.6); a decrease in the mean Kellner Symptom Questionnaire depression subscale score of –7.7 (95% CI, –9.6 to –5.8), and a decrease in the MADRS total score of –14.2 (95% CI, –16.7 to –11.6).
From week 6 to week 10, when brexpiprazole was discontinued, the Kellner Symptom Questionnaire showed a worsening of depressive symptoms with a mean change of 2.1 points (95% CI, 0.1 to 4.2).
The authors concluded, “adjunctive treatment with brexpiprazole may represent a strategy for the treatment of irritability symptoms in patients with MDD.” They also declared that their results should be viewed as preliminary and that further studies should use a larger sample size that excludes the possibility of any placebo responses.
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