scholarly journals A pooled post hoc analysis evaluating the safety and tolerability of cariprazine in bipolar depression

2020 ◽  
Vol 263 ◽  
pp. 386-395
Author(s):  
Willie R. Earley ◽  
Maria Burgess ◽  
Ludmyla Rekeda ◽  
Arlene Hankinson ◽  
Roger S. McIntyre ◽  
...  
Keyword(s):  
Bipolar Depression ◽  
Post Hoc Analysis ◽  
Post Hoc

scholarly journals 160 Lurasidone and Metabolic Syndrome: Results from Short- and Long-Term Clinical Studies in Patients with Bipolar Depression

CNS Spectrums ◽  
2020 ◽  
Vol 25 (2) ◽  
pp. 302-303
Author(s):  
Michael Tocco ◽  
John W. Newcomer ◽  
Yongcai Mao ◽  
Andrei Pikalov
Keyword(s):  
Metabolic Syndrome ◽  
Adjunctive Therapy ◽  
Bipolar Depression ◽  
Prevention Study ◽  
Short Term ◽  
Post Hoc Analysis ◽  
Short And Long Term ◽  
Post Hoc ◽  
Therapy Studies

Abstract:Background:Among patients with depressive disorders, the prevalence of metabolic syndrome (MetS) is estimated to range from 35-40% and has been associated with increased mortality rates. The aim of this post-hoc analysis was to assess the effect of treatment with lurasidone on the prevalence of MetS in patients with bipolar depression.Method:Lurasidone data (dose range, 20-120 mg/d) used in the current analyses consisted of 3 double-blind (DB), placebo-controlled, 6-week studies in adults with bipolar I depression (total N=1,192), consisting of 1 monotherapy, and 2 adjunctive therapy trials with lithium or valproate. Patients who completed the short-term trials continued into a 6-month open-label (OL) extension study, with 6-month (LOCF-endpoint) data available on 274 patients treated with lurasidone monotherapy, and 436 patients treated with lurasidone adjunctive therapy. Also analyzed was a recurrence prevention study in stabilized bipolar patients who completed up to 20 weeks of OL adjunctive treatment with lurasidone, and then were randomized to 28 weeks of DB adjunctive therapy with lurasidone or placebo (N=497). MetS was defined based on NCEP ATP III criteria (2005 revision).Results:In the short-term monotherapy and adjunctive therapy studies, the proportion of patients at baseline meeting NCEP III criteria for MetS were 27.6% and 23.6%, respectively, for lurasidone, and 23.8% and 25.1%, respectively, for placebo; and at week 6 (LOCF) the proportion with MetS was 27.5% and 26.6%, respectively, for lurasidone and 29.9% and 20.2%, respectively, for placebo. The proportion of patients who did not meet MetS criteria at baseline but developed MetS at week 6 (LOCF) was similar for lurasidone vs. placebo in the monotherapy study (9.9% vs. 11.6%); and in the two adjunctive therapy studies (10.3% vs. 8.3%). During the 6-month OL extension study, the proportion of patients treated with lurasidone monotherapy and adjunctive therapy who did not meet MetS criteria at OL baseline but developed MetS at month 6 (LOCF) was 11.7% and 11.9%, respectively. Conversely, the proportion of patients who met MetS criteria at OL baseline, but no longer met criteria at month 6 (LOCF) was 9.5% and 7.7%, respectively. In the 20-week, OL phase of the recurrence prevention study, the proportion of patients treated with adjunctive lurasidone who did not meet MetS criteria at OL baseline but developed MetS at endpoint was 11.5% (LOCF). After up to 28 weeks of DB treatment, the proportion of patients who did not meet MetS criteria at DB baseline but developed MetS at endpoint was 9.0% in the adjunctive lurasidone group, and 10.5% in the adjunctive placebo group (LOCF).Conclusion:This post-hoc analysis found that short- and long-term treatment with lurasidone was associated with a relatively low risk for the development of metabolic syndrome in patients with bipolar I disorder. These findings are consistent with similar analyses in patients with schizophrenia.Funding Acknowledgements:Supported by funding from Sunovion Pharmaceuticals Inc.

scholarly journals Cariprazine efficacy in bipolar I depression with and without concurrent manic symptoms: post hoc analysis of 3 randomized, placebo-controlled studies

CNS Spectrums ◽  
2019 ◽  
Vol 25 (4) ◽  
pp. 502-510 ◽  
Author(s):  
Roger S. McIntyre ◽  
Trisha Suppes ◽  
Willie Earley ◽  
Mehul Patel ◽  
Stephen M. Stahl
Keyword(s):  
Least Squares ◽  
Rating Scale ◽  
Bipolar Depression ◽  
Simultaneous Occurrence ◽  
Madrs Total Score ◽  
Young Mania ◽  
Double Blind ◽  
Post Hoc Analysis ◽  
Manic Symptoms ◽  
Post Hoc

AbstractObjective.Mixed presentations, defined by simultaneous occurrence of depressive and manic symptoms, are difficult to treat. Antidepressants, although commonly used, have weak evidence of efficacy and may increase risk of mood destabilization. The aim of this pooled post hoc analysis was to evaluate the efficacy of cariprazine in the treatment of bipolar depression with or without concurrent manic symptoms.Methods.Patients from 3 randomized, double-blind, placebo-controlled studies who met DSM-IV-TR or DSM-5 criteria for bipolar I disorder with a current major depressive episode were identified to have concurrent manic symptoms by baseline Young Mania Rating Scale total score ≥4. Efficacy was assessed in cariprazine 1.5 and 3 mg/day dose groups versus placebo; analyses included the least squares mean change from baseline to week 6 in Montgomery-Åsberg Depression Rating Scale (MADRS) total score.Results.Of 1383 patients randomized to treatment, 808 (58.4%) had concurrent manic symptoms. For patients with manic symptoms, mean reduction in MADRS total score from baseline to week 6 was significantly greater for both cariprazine 1.5 and 3 mg/day compared with placebo, with least squares mean differences (LSMDs) versus placebo of −2.5 (p = .0033) and −2.9 (p = .0010), respectively; for patients without manic symptoms, the LSMD was significant for 1.5 mg/day (−3.3; p = .0008), but not for 3 mg/day (−1.9; p = .0562).Conclusion.The results of this post hoc analysis suggest that cariprazine may be an appropriate treatment option for patients with bipolar I depression with or without manic symptoms, with higher doses potentially more effective in patients with manic symptoms.

scholarly journals Recovery in bipolar depression: Post-hoc analysis of a placebo-controlled lurasidone trial followed by a long-term continuation study

2015 ◽  
Vol 186 ◽  
pp. 376-382 ◽  
Author(s):  
Antony Loebel ◽  
Cynthia Siu ◽  
Krithika Rajagopalan ◽  
Andrei Pikalov ◽  
Josephine Cucchiaro ◽  
...  
Keyword(s):  
Bipolar Depression ◽  
Post Hoc Analysis ◽  
Post Hoc

scholarly journals Mania and bipolar depression: complementing not opposing poles—a post-hoc analysis of mixed features in manic and hypomanic episodes

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Christoph Born ◽  
Heinz Grunze ◽  
Robert M. Post ◽  
Lori L. Altshuler ◽  
Ralph Kupka ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Bipolar Depression ◽  
Correlation Coefficients ◽  
Post Hoc Analysis ◽  
Dsm 5 ◽  
Mixed Features ◽  
Symptom Load ◽  
Patient Groups ◽  
Sum Scores ◽  
Post Hoc

Abstract Background Depending on the classification system used, 5–40% of manic subjects present with concomitant depressive symptoms. This post-hoc analysis evaluates the hypothesis that (hypo)manic subjects have a higher burden of depression than non-(hypo)manic subjects. Methods Data from 806 Bipolar I or II participants of the Stanley Foundation Bipolar Network (SFBN) were analyzed, comprising 17,937 visits. A split data approach was used to separate evaluation and verification in independent samples. For verification of our hypotheses, we compared mean IDS-C scores ratings of non-manic, hypomanic and manic patients. Data were stored on an SQL-server and extracted using standard SQL functions. Linear correlation coefficients and pivotal tables were used to characterize patient groups. Results Mean age of participants was 40 ± 12 years (range 18–81). 460 patients (57.1%) were female and 624 were diagnosed as having bipolar I disorder (77.4%) and 182 with bipolar II (22.6%). Data of 17,937 visits were available for analyses, split into odd and even patient numbers and stratified into three groups by YMRS-scores: not manic < 12, hypomanic < 21, manic < 30. Average IDS-C sum scores in manic or hypomanic states were significantly higher (p < .001) than for non-manic states. (Hypo)manic female patients were likely to show more depressive symptoms than males (p < .001). Similar results were obtained when only the core items of the YMRS or only the number of depressive symptoms were considered. Analyzing the frequency of (hypo)manic mixed states applying a proxy of the DSM-5 mixed features specifier extracted from the IDS-C, we found that almost 50% of the (hypo)manic group visits fulfilled DSM-5 mixed features specifier criteria. Conclusion Subjects with a higher manic symptom load are also significantly more likely to experience a higher number of depressive symptoms. Mania and depression are not opposing poles of bipolarity but complement each other.

Sign in / Sign up

Export Citation Format

Share Document