DSM-5 mixed specifier for manic episodes: Evaluating the effect of depressive features on severity and treatment outcome using asenapine clinical trial data |
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Authors: | R.S. McIntyre M. Tohen M. Berk J. Zhao E. Weiller |
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Affiliation: | 1. Mood Disorders Psychopharmacology Unit, University Health Network, University of Toronto, ON, Canada M5T 2S8;2. University of New Mexico, Health Science Center, Department of Psychiatry, Albuquerque, NM, USA;3. Deakin University School of Medicine, VIC, Australia;4. The University of Melbourne, Department of Psychiatry, Parkville, VIC, Australia;;5. Orygen Youth Health Research Centre, Parkville, VIC, Australia;6. Florey Institute for Neuroscience and Mental Health, Parkville, VIC, Australia;g Merck, Whitehouse Station, NJ 08889, USA;h H Lundbeck A/S, Corporate Medical Affairs, Valby, Copenhagen, Denmark |
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Abstract: | BackgroundTo describe the frequency of mixed specifier as proposed in DSM-5 in bipolar I patients with manic episodes, and to evaluate the effect of mixed specifier on symptom severity and treatment outcome.MethodsThis post-hoc analysis used proxies for DSM-5 mixed features specifier by using MADRS or PANSS items.ResultsOf the 960 patients analysed, 34%, 18% and 4.3% of patients, respectively, had ≥3 depressive features with mild (score ≥1 for MADRS items and ≥2 for PANSS item), moderate (score ≥2 MADRS, ≥3 PANSS) and severe (score ≥3 MADRS, ≥4 PANSS) symptoms. In patients with ≥3 depressive features and independent of treatment: MADRS remission (score ≤12) rate decreased with increasing severity (61–43%) and YMRS remission (score ≤12) was similar for mild and moderate patients (36–37%), but higher for severe (54%). In asenapine-treated patients, the MADRS remission rate was stable regardless of baseline depressive symptom severity (range 64–67%), whereas remission decreased with increasing severity with olanzapine (63–38%) and placebo (49–25%). Reduction in YMRS was significantly greater for asenapine compared with placebo at day 2 across the 3 severity cut-offs and continued to decrease throughout the treatment period. The difference between olanzapine and placebo was statistically significant in mild and moderate patients.LimitationsResults are from post-hoc analyses.ConclusionsThese analyses support the validity of proposed DSM-5 criteria. They confirm that depressive features are frequent in bipolar patients with manic episodes. With increasing baseline severity of depressive features, treatment outcome was poorer with olanzapine and placebo, but remained stable with asenapine. |
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Keywords: | Bipolar I disorder DSM-5 mixed specifier Depressive features Manic episode Asenapine Olanzapine |
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