Comparison of adjunctive use of aripiprazole with bupropion or selective serotonin reuptake inhibitors/serotonin–norepinephrine reuptake inhibitors: analysis of patients beginning adjunctive treatment in a 52-week, open-label study

BMC Research Notes

Michael E Thase⁵  Robert M Berman⁴  Ronald Marcus⁴  Sabrina Vogel Marler⁴  Robert A Forbes²  Zachary J Cain¹  John J Sheehan¹  Ross A Baker²  Anita H Clayton³ 

[1] Bristol-Myers Squibb, Plainsboro, 777 Scudders Mill Road, Plainsboro NJ 08536, USA;Otsuka Pharmaceutical Development & Commercialization, 1 University Square Drive, Princeton NJ 08540, USA;Department of Psychiatry and Neurobehavioral Sciences, The University of Virginia, Charlottesville, 2955 Ivy Rd, Northridge Suite 210, Charlottesville VA 22903, USA;Bristol-Myers Squibb, Wallingford, CT, USA;Department of Psychiatry, University of Pennsylvania School of Medicine, 3535 Market Street, Suite 670, Philadelphia, PA 19104, USA

关键词: Sexual dysfunction;    Serotonin–norepinephrine reuptake inhibitors;    Selective serotonin reuptake inhibitors;    Major depressive disorder;    Dopamine;    Bupropion;    Aripiprazole;    Atypical antipsychotic;    Adjunctive antidepressant;   

Others  :  1131864
DOI  :  10.1186/1756-0500-7-459

 received in 2014-05-06, accepted in 2014-05-15,  发布年份 2014

【 摘 要 】

Background

This post hoc analysis assessed the safety, tolerability and effectiveness of long-term treatment with aripiprazole adjunctive to either bupropion or selective serotonin reuptake inhibitors (SSRIs)/serotonin–norepinephrine reuptake inhibitors (SNRIs) in patients with major depressive disorder (MDD).

Methods

Data from de novo patients (did not participate in 2 previous studies) in a 52-week, open-label safety study of adjunctive aripiprazole after documented inadequate response to 1–4 antidepressant treatments (ADTs; SSRI, SNRI, or bupropion) were analyzed post hoc. Assessments included safety and tolerability, sexual functioning (Massachusetts General Hospital Sexual Functioning Inventory [MGH-SFI]) and Clinical Global Impressions–Severity (CGI-S).

Results

Forty-seven patients received bupropion plus aripiprazole and 245 received an SSRI/SNRI plus aripiprazole; 19 (40.4%) and 78 (31.8%), respectively, completed 52 weeks of treatment, and 46 and 242, respectively, received ≥1 dose of study medication (safety sample). Median time to discontinuation (any reason) was 184.0 days. Overall, 97.8% of patients in the bupropion group and 93.8% in the SSRI/SNRI group experienced ≥1 adverse event. The most common treatment-emergent adverse events were fatigue (26.1%) and somnolence (21.7%) with bupropion and fatigue (23.6%) and akathisia (23.6%) with an SSRI/SNRI. Mean change in body weight at week 52 (observed cases) was +3.1 kg for bupropion and +2.4 kg for an SSRI/SNRI. Treatment-emergent, potentially clinically relevant abnormalities in fasting glucose occurred in 8.3% of patients with bupropion and 17.4% with an SSRI/SNRI; for abnormalities in fasting total cholesterol, the incidence was 25.0% and 34.7%, respectively. Mean (SE) change from baseline in fasting glucose was 1.4 (1.9) mg/dL with bupropion and 2.7 (1.5) mg/dL with an SSRI/SNRI. Baseline MGH-SFI item scores indicated less severe impairment with bupropion versus an SSRI/SNRI; in both groups most MGH-SFI items exhibited improvement at week 52. Mean CGI-S improvement at week 52 (last observation carried forward) was -1.4 with bupropion and -1.5 with an SSRI/SNRI (efficacy sample).

Conclusions

There were no unexpected AEs with long-term adjunctive aripiprazole therapy when added to either bupropion or SSRIs/SNRIs, and symptom improvement was similar between ADT groups. Sexual functioning in patients with MDD on antidepressants was also modestly improved after adding aripiprazole.

Trial registration

ClinicalTrials.gov:NCT00095745 (November 9, 2004).

【 授权许可】

   
2014 Clayton et al.; licensee BioMed Central Ltd.

【 图 表 】

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