Lurasidone for the Treatment of Major Depressive Disorder with Mixed Features: Do Manic Symptoms Moderate Treatment Response?

2017 ◽  
Vol 41 (S1) ◽  
pp. s243-s243 ◽  
Author(s):  
A. Pikalov ◽  
J. Goldberg ◽  
Y. Mao ◽  
C. Siu ◽  
J. Tsai ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Latent Class ◽  
Manic Symptom ◽  
Major Depressive ◽  
Post Hoc Analysis ◽  
Manic Symptoms ◽  
Symptom Profile ◽  
Mixed Features ◽  
Post Hoc

BackgroundThis post-hoc analysis evaluated whether the efficacy of lurasidone in major depressive disorder (MDD) with mixed features is moderated by the number and characteristics of manic symptoms present at study baseline.MethodsPatients meeting DSM-IV-TR criteria for MDD who presented with two or three manic symptoms (consistent with the DSM–5 mixed features specifier) were randomly assigned to 6 weeks of double-blind treatment with either lurasidone 20–60 mg/d (n = 109) or placebo (n = 100). Finite mixture models were applied to identify latent class patterns of the 10 baseline manic symptoms.ResultsThree latent class profiles were identified: 105 (50.5%) patients had manic symptom profile 1 (MIX 1) with mean MADRS 33.0, mean YMRS 9.2, mean number of manic symptoms 3.8; 63 (30.3%) patients had manic symptom profile 2 (MIX 2) with similar baseline mean MADRS (32.4) and YMRS (9.3) and lower number of manic symptoms 3.5; 40 patients had manic symptom profile 3 (MIX 3) with significantly higher severity scores in MADRS (35) and YMRS (14.9) and mean number of manic symptoms 4.6. A significant moderating effect on change in YMRS score was observed for the “decreased need for sleep” symptom, with greater lurasidone effect size (vs. Placebo) found in patients without vs. With this symptom (P < 0.05).ConclusionsIn this post-hoc analysis of a placebo-controlled trial involving MDD patients with mixed features, absence of “decreased need for sleep” was found to be significantly associated with improvement in manic and depressive symptoms and to moderate the treatment effect on manic symptoms.Disclosure of interestI am full time employee of Sunovion pharmaceuticals Inc.

scholarly journals Lurasidone for major depressive disorder with mixed features and anxiety: a post-hoc analysis of a randomized, placebo-controlled study

CNS Spectrums ◽  
2017 ◽  
Vol 22 (2) ◽  
pp. 236-245 ◽  
Author(s):  
Joyce Tsai ◽  
Michael E. Thase ◽  
Yongcai Mao ◽  
Daisy Ng-Mak ◽  
Andrei Pikalov ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Rating Scale ◽  
Controlled Study ◽  
Madrs Total Score ◽  
Major Depressive ◽  
Post Hoc Analysis ◽  
Mixed Features ◽  
Post Hoc ◽  
Severe Anxiety

ObjectiveThe aim of this post-hoc analysis was to evaluate the efficacy of lurasidone in treating patients with major depressive disorder (MDD) with mixed features who present with mild and moderate-to-severe levels of anxiety.MethodsThe data in this analysis were derived from a study of patients meeting the DSM–IV–TR criteria for unipolar MDD, with a Montgomery–Åsberg Depression Rating Scale (MADRS) total score ≥26, presenting with two or three protocol-defined manic symptoms, who were randomized to 6 weeks of double-blind treatment with either lurasidone 20–60 mg/day (n=109) or placebo (n=100). Anxiety severity was evaluated using the Hamilton Anxiety Rating Scale (HAM–A). To evaluate the effect of baseline anxiety on response to lurasidone, the following two anxiety groups were defined: mild anxiety (HAM–A≤14) and moderate-to-severe anxiety (HAM–A≥15). Change from baseline in MADRS total score was analyzed for each group using a mixed model for repeated measures.ResultsTreatment with lurasidone was associated with a significant week 6 change versus placebo in MADRS total score for patients with both mild anxiety (–18.4 vs. –12.8, p<0.01, effect size [ES]=0.59) and moderate-to-severe anxiety (–22.0 vs. –13.0, p<0.001, ES=0.95). Treatment with lurasidone was associated with a significant week 6 change versus placebo in HAM–A total score for patients with both mild anxiety (–7.6 vs. –4.0, p<0.01, ES=0.62), and moderate-to-severe anxiety (–11.4 vs. –6.1, p<0.0001, ES=0.91).ConclusionsIn this post-hoc analysis of an MDD with mixed features and anxiety population, treatment with lurasidone was associated with significant improvement in both depressive and anxiety symptoms in subgroups with mild and moderate-to-severe levels of anxiety at baseline.

scholarly journals Lurasidone for major depressive disorder with mixed features and irritability: a post-hoc analysis

CNS Spectrums ◽  
2017 ◽  
Vol 22 (2) ◽  
pp. 228-235 ◽  
Author(s):  
Alan C. Swann ◽  
Maurizio Fava ◽  
Joyce Tsai ◽  
Yongcai Mao ◽  
Andrei Pikalov ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Repeated Measures ◽  
Mixed Model ◽  
Rating Scale ◽  
Major Depressive ◽  
Double Blind ◽  
Post Hoc Analysis ◽  
Mixed Features ◽  
Post Hoc

ObjectiveThe aim of this post-hoc analysis was to evaluate the efficacy of lurasidone in treating major depressive disorder (MDD) with mixed features including irritability.MethodsThe data in this analysis were derived from a study of patients meeting DSM–IV–TR criteria for unipolar MDD, with a Montgomery–Åsberg Depression Rating Scale (MADRS) total score ≥26, presenting with two or three protocol-defined manic symptoms, and who were randomized to 6 weeks of double-blind treatment with either lurasidone 20–60 mg/d (n=109) or placebo (n=100). We defined “irritability” as a score ≥2 on both the Young Mania Rating Scale (YMRS) irritability item (#5) and the disruptive-aggressive item (#9). Endpoint change in the MADRS and YMRS items 5 and 9 were analyzed using a mixed model for repeated measures for patients with and without irritability.ResultsSome 20.7% of patients met the criteria for irritability. Treatment with lurasidone was associated with a significant week 6 change vs. placebo in MADRS score in both patients with (–22.6 vs. –9.5,p<0.0001, effect size [ES]=1.4) and without (–19.9 vs. –13.8,p<0.0001,ES=0.7) irritability. In patients with irritable features, treatment with lurasidone was associated with significant week 6 changes vs. placebo in both the YMRS irritability item (–1.4 vs. –0.3,p=0.0012,ES=1.0) and the YMRS disruptive-aggressive item (–1.0 vs. –0.3,p=0.0002,ES=1.2).ConclusionsIn our post-hoc analysis of a randomized, placebo-controlled, 6-week trial, treatment with lurasidone significantly improved depressive symptoms in MDD patients with mixed features including irritability. In addition, irritability symptoms significantly improved in patients treated with lurasidone.

Measures of the DSM–5 mixed-features specifier of major depressive disorder

CNS Spectrums ◽  
2017 ◽  
Vol 22 (2) ◽  
pp. 196-202 ◽  
Author(s):  
Mark Zimmerman
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Antidepressant Medication ◽  
Reliability And Validity ◽  
Mixed States ◽  
Major Depressive ◽  
Manic Symptoms ◽  
Dsm 5 ◽  
Depressed Patients ◽  
Mixed Features

During the past two decades, a number of studies have found that depressed patients frequently have manic symptoms intermixed with depressive symptoms. While the frequency of mixed syndromes are more common in bipolar than in unipolar depressives, mixed states are also common in patients with major depressive disorder. The admixture of symptoms may be evident when depressed patients present for treatment, or they may emerge during ongoing treatment. In some patients, treatment with antidepressant medication might precipitate the emergence of mixed states. It would therefore be useful to systematically inquire into the presence of manic/hypomanic symptoms in depressed patients. We can anticipate that increased attention will likely be given to mixed depression because of changes in the DSM–5. In the present article, I review instruments that have been utilized to assess the presence and severity of manic symptoms and therefore could be potentially used to identify the DSM–5 mixed-features specifier in depressed patients and to evaluate the course and outcome of treatment. In choosing which measure to use, clinicians and researchers should consider whether the measure assesses both depression and mania/hypomania, assesses all or only some of the DSM–5 criteria for the mixed-features specifier, or assesses manic/hypomanic symptoms that are not part of the DSM–5 definition. Feasibility, more so than reliability and validity, will likely determine whether these measures are incorporated into routine clinical practice.

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