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Adjunctive Brexpiprazole in Patients With Major Depressive Disorder and Irritability: An Exploratory Study
Maurizio Fava1,2, François Ménard3, Charlotte Kampp Davidsen3
1Massachusetts General Hospital, 55 Fruit St, Bulfinch 351, Boston, MA 02114. mfava@mgh.harvard.edu.
Objective:
To evaluate the effects of adjunctive brexpiprazole on symptoms of irritability in patients with major depressive disorder (MDD).
Methods:
Patients diagnosed with MDD according to DSM-IV-TR criteria who had inadequate response to antidepressant treatment continued treatment with their current antidepressant for 2 weeks. Patients still having inadequate response, and with irritability, received 6 weeks of open-label treatment with their current antidepressant at the same dose and adjunctive brexpiprazole (target dose: 3 mg/d). Brexpiprazole was discontinued at week 6, and the patients continued with their antidepressant until week 10. Changes from baseline to week 6 and week 6 to week 10 were analyzed.
Results:
This study was conducted between October 7, 2013, and July 30, 2014. Fifty-four patients were treated with adjunctive brexpiprazole. At week 6, clinically relevant improvements were observed in Sheehan Irritability Scale total (-21.1) and item 1 (irritable mood) (-3.5) scores, Kellner Symptom Questionnaire total (-24.4) and anger-hostility subscale (-7.7) scores, and 30-item Inventory of Depressive Symptomatology, clinician version (IDS-C₃₀), item 6 (irritable mood) score (-1.2). More (15 patients) stopped than developed (5 patients) anger attacks during treatment, as measured by the Anger Attacks Questionnaire. The Clinical Global Impressions-Severity of Illness score improved (-1.4), as did the depressive symptoms (IDS-C₃₀ total score, -17.8; Kellner Symptom Questionnaire depression subscale score, -7.7; and Montgomery-Asberg Depression Rating Scale total score, -14.2). Irritability symptoms worsened after brexpiprazole discontinuation, assessed at week 10. Adjunctive brexpiprazole was well tolerated.
Conclusions:
Adjunctive treatment with brexpiprazole may represent a strategy for patients with MDD and inadequate response to antidepressant treatment who have symptoms of irritability.
Trials Registration:
ClinicalTrials.gov identifier: NCT01942785.
Insights
Adjunctive brexpiprazole improved irritability and depressive symptoms in major depressive disorder (MDD) patients with inadequate antidepressant response. Symptoms returned after brexpiprazole discontinuation, indicating its efficacy in managing MDD irritability.
Area of Science:
- Psychiatry
- Pharmacology
- Clinical Medicine
Background:
- Major Depressive Disorder (MDD) is a prevalent mental health condition.
- Irritability is a common and distressing symptom in MDD.
- Antidepressant treatment is not always effective for all MDD patients.
Purpose of the Study:
- To assess the efficacy of adjunctive brexpiprazole in reducing irritability symptoms in MDD patients.
- To evaluate the impact of brexpiprazole on overall depressive symptoms and illness severity.
- To determine if irritability symptoms rebound after brexpiprazole discontinuation.
Main Methods:
- Open-label, 6-week trial of adjunctive brexpiprazole (3 mg/d) in MDD patients with inadequate antidepressant response and irritability.
- Patients continued their existing antidepressant medication.
- Symptom changes were assessed using validated scales (Sheehan Irritability Scale, Kellner Symptom Questionnaire, IDS-C30, Anger Attacks Questionnaire, CGI-SI, MADRS).
Main Results:
- Adjunctive brexpiprazole significantly improved irritability symptoms (Sheehan, Kellner, IDS-C30) and reduced anger attacks.
- Depressive symptoms and illness severity also showed significant improvement.
- Irritability symptoms recurred upon discontinuation of brexpiprazole at week 10.
- The treatment was well-tolerated by the study participants.
Conclusions:
- Adjunctive brexpiprazole is a potential therapeutic option for MDD patients experiencing irritability despite adequate antidepressant treatment.
- Brexpiprazole effectively manages irritability symptoms, suggesting a targeted role in treatment-resistant MDD.
- The findings support brexpiprazole's utility in addressing specific symptom domains within MDD.
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