Abstract
Evidence supporting the use of second generation antipsychotics (SGAs) in the treatment of acute depression with mixed features (MFs) associated with bipolar disorder (BD) is scarce and equivocal. Therefore, we conducted a systematic review and preliminary meta-analysis investigating SGAs in the treatment of acute BD depression with MFs. Two authors independently searched major electronic databases from 1990 until September 2015 for randomized (placebo-) controlled trials (RCTs) or open-label clinical trials investigating the efficacy of SGAs in the treatment of acute bipolar depression with MFs. A random-effect meta-analysis calculating the standardized mean difference (SMD) between SGA and placebo for the mean baseline to endpoint change in depression as well as manic symptoms score was computed based on 95% confidence intervals (CI). Six RCTs and one open-label placebo-controlled studies (including post-hoc reports) representing 1023 patients were included. Participants received either ziprasidone, olanzapine, lurasidone, quetiapine or asenapine for an average of 6.5 weeks across the included studies. Meta-analysis with Duval and Tweedie adjustment for publication bias demonstrated that SGA resulted in significant improvements of (hypo-)manic symptoms of bipolar mixed depression as assessed by the means of the total scores of the Young Mania Rating Scale (YMRS) (SMD −0.74, 95% CI −1.20 to −0.28, n SGA = 907, control = 652). Meta-analysis demonstrated that participants in receipt of SGA (n = 979) experienced a large improvement in the Montgomery–Åsberg Depression Rating Scale (MADRS) scores (SMD −1.08, 95% CI −1.35 to −0.81, p < 0.001) vs. placebo (n = 678). Publication and measurement biases and relative paucity of studies. Overall, SGAs appear to offer favorable improvements in MADRS and YMRS scores vs. placebo. Nevertheless, given the preliminary nature of the present report, additional original studies are required to allow more reliable and clinically definitive conclusions.
Highlights
Since their introduction, the number of second-generation antipsychotic (SGA) drugs prescribed to bipolar disorder (BD) patients appears to have steadily increased across the worldwide [1,2,3]
Our study found that there is some early and promising evidence for the use of SGA to improve BD depression in people with mixed features (MFs)
The results from our exploratory meta-analysis results are encouraging, demonstrating that SGA results in significant and large improvements in MADRS scores (SMD 1.08, 95% CI1.35 to0.81, p < 0.001)
Summary
The number of second-generation antipsychotic (SGA) drugs prescribed to bipolar disorder (BD) patients appears to have steadily increased across the worldwide [1,2,3]. Further higher figures of MFs associated to bipolar depression could be expected in the clinical setting, including primary care setting [7], considering that the validity of the DSM-5 codes for MFs themselves has been questioned [12,13,14,15,16]. Albeit representing trans-nosological features, such excluded features of bipolar and unipolar depression are perceived as the actual differential diagnostic features by many clinicians [17,18,19,20,21,22] Taken altogether, these issues point to the compelling need for both an enhanced recognition and discriminant validity of bipolar MFs [23,24,25,26] as well as a more effective, evidence-based pharmacological treatment, with a special emphasis towards SGAs [27,28]. To the best of our knowledge, the present meta-analysis of (placebo)-controlled clinical trials (RCTs) represents the first preliminary report investigating the use of SGAs in the treatment of MFs in BD
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