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- Title
Randomized, double-blind comparison of aripiprazole/ sertraline combination and placebo/sertraline combination in patients with major depressive disorder.
- Authors
Kunitoshi Kamijima; Mahito Kimura; Kazuo Kuwahara; Yuri Kitayama; Yoshihiro Tadori
- Abstract
Aim: This study compared the efficacy and safety of aripiprazole/sertraline combination (ASC) and placebo/ sertraline combination (PSC) in patients with major depressive disorder (MDD) who showed an inadequate response to sertraline 100 mg/day. Methods: The study comprised a screening period, an 8-week prospective treatment (single-blind sertraline 25-100 mg/day) period, and a 6-week double-blind treatment period. Patients with DSM-5-defined MDD were enrolled. Following the prospective treatment, non-responders were randomly assigned to the ASC group (aripiprazole 3-12 mg/day/sertraline 100 mg/ day) or the PSC group (sertraline 100 mg/day). The primary efficacy end-point was the mean change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to 6 weeks. Results: A total of 412 patients were randomly assigned to either the ASC group (n = 209) or the PSC group (n = 203). Mean change in MADRS total score was significantly greater in patients with ASC than PSC (−9.2 vs −7.2; P = 0.0070). Treatmentemergent adverse events (TEAE) that occurred in ≥10% of patients with ASC versus PSC were nasopharyngitis (13.4% vs 11.3%) and akathisia (12.9% vs 3.4%). All TEAE reported in the ASC group were mild or moderate in severity. Rates of discontinuations due to TEAE were low in both the ASC (1.9%) and PSC (1.5%) groups. There were no notable issues in safety assessments in the ASC group compared with the PSC group. Conclusion: In patients with MDD who showed an inadequate response to treatment with sertraline 100 mg/day, ASC was efficacious and well tolerated.
- Subjects
MENTAL depression; SERTRALINE; RANDOMIZED controlled trials; ANTIDEPRESSANTS; NEUROSES
- Publication
Psychiatry & Clinical Neurosciences, 2018, Vol 72, Issue 8, p591
- ISSN
1323-1316
- Publication type
Article
- DOI
10.1111/pcn.12663