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Lurasidone as adjunctive therapy with lithium or valproate for the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study.
Am J Psychiatry. 2014 Feb; 171(2):169-77.AJ

Abstract

OBJECTIVE

Few studies have been reported that support the efficacy of adjunctive therapy for patients with bipolar I depression who have had an insufficient response to monotherapy with mood-stabilizing agents. The authors investigated the efficacy of lurasidone, a novel antipsychotic agent, as adjunctive therapy with lithium or valproate for the treatment of bipolar I depression.

METHOD

Patients were randomly assigned to receive 6 weeks of double-blind adjunctive treatment with lurasidone (N=183) or placebo (N=165), added to therapeutic levels of either lithium or valproate. Primary and key secondary endpoints were change from baseline to week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) and depression severity score on the Clinical Global Impressions scale for use in bipolar illness (CGI-BP), respectively.

RESULTS

Lurasidone treatment significantly reduced mean MADRS total score at week 6 compared with the placebo group (-17.1 versus -13.5; effect size=0.34). Similarly, lurasidone treatment resulted in significantly greater endpoint reduction in CGI-BP depression severity scores compared with placebo (-1.96 versus -1.51; effect size=0.36) as well as significantly greater improvement in anxiety symptoms and in patient-reported measures of quality of life and functional impairment. Discontinuation rates due to adverse events were 6.0% and 7.9% in the lurasidone and placebo groups, respectively. Adverse events most frequently reported for lurasidone were nausea, somnolence, tremor, akathisia, and insomnia. Minimal changes in weight, lipids, and measures of glycemic control were observed during treatment with lurasidone.

CONCLUSIONS

In patients with bipolar I depression, treatment with lurasidone adjunctive to lithium or valproate significantly improved depressive symptoms and was generally well tolerated.

Authors

No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24170221

Citation

Loebel, Antony, et al. "Lurasidone as Adjunctive Therapy With Lithium or Valproate for the Treatment of Bipolar I Depression: a Randomized, Double-blind, Placebo-controlled Study." The American Journal of Psychiatry, vol. 171, no. 2, 2014, pp. 169-77.
Loebel A, Cucchiaro J, Silva R, et al. Lurasidone as adjunctive therapy with lithium or valproate for the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 2014;171(2):169-77.
Loebel, A., Cucchiaro, J., Silva, R., Kroger, H., Sarma, K., Xu, J., & Calabrese, J. R. (2014). Lurasidone as adjunctive therapy with lithium or valproate for the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. The American Journal of Psychiatry, 171(2), 169-77. https://doi.org/10.1176/appi.ajp.2013.13070985
Loebel A, et al. Lurasidone as Adjunctive Therapy With Lithium or Valproate for the Treatment of Bipolar I Depression: a Randomized, Double-blind, Placebo-controlled Study. Am J Psychiatry. 2014;171(2):169-77. PubMed PMID: 24170221.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Lurasidone as adjunctive therapy with lithium or valproate for the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. AU - Loebel,Antony, AU - Cucchiaro,Josephine, AU - Silva,Robert, AU - Kroger,Hans, AU - Sarma,Kaushik, AU - Xu,Jane, AU - Calabrese,Joseph R, PY - 2013/10/31/entrez PY - 2013/10/31/pubmed PY - 2014/4/4/medline SP - 169 EP - 77 JF - The American journal of psychiatry JO - Am J Psychiatry VL - 171 IS - 2 N2 - OBJECTIVE Few studies have been reported that support the efficacy of adjunctive therapy for patients with bipolar I depression who have had an insufficient response to monotherapy with mood-stabilizing agents. The authors investigated the efficacy of lurasidone, a novel antipsychotic agent, as adjunctive therapy with lithium or valproate for the treatment of bipolar I depression. METHOD Patients were randomly assigned to receive 6 weeks of double-blind adjunctive treatment with lurasidone (N=183) or placebo (N=165), added to therapeutic levels of either lithium or valproate. Primary and key secondary endpoints were change from baseline to week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) and depression severity score on the Clinical Global Impressions scale for use in bipolar illness (CGI-BP), respectively. RESULTS Lurasidone treatment significantly reduced mean MADRS total score at week 6 compared with the placebo group (-17.1 versus -13.5; effect size=0.34). Similarly, lurasidone treatment resulted in significantly greater endpoint reduction in CGI-BP depression severity scores compared with placebo (-1.96 versus -1.51; effect size=0.36) as well as significantly greater improvement in anxiety symptoms and in patient-reported measures of quality of life and functional impairment. Discontinuation rates due to adverse events were 6.0% and 7.9% in the lurasidone and placebo groups, respectively. Adverse events most frequently reported for lurasidone were nausea, somnolence, tremor, akathisia, and insomnia. Minimal changes in weight, lipids, and measures of glycemic control were observed during treatment with lurasidone. CONCLUSIONS In patients with bipolar I depression, treatment with lurasidone adjunctive to lithium or valproate significantly improved depressive symptoms and was generally well tolerated. SN - 1535-7228 UR - https://www.unboundmedicine.com/medline/citation/24170221/Lurasidone_as_adjunctive_therapy_with_lithium_or_valproate_for_the_treatment_of_bipolar_I_depression:_a_randomized_double_blind_placebo_controlled_study_ L2 - https://ajp.psychiatryonline.org/doi/full/10.1176/appi.ajp.2013.13070985?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -