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Randomized, placebo-controlled, adjunctive study of armodafinil for bipolar I depression: implications of novel drug design and heterogeneity of concurrent bipolar maintenance treatments. International journal of bipolar disorders Frye, M. A., Amchin, J., Bauer, M., Adler, C., Yang, R., Ketter, T. A. 2015; 3 (1): 34-?

Abstract

Some, but not all, prior investigations suggest armodafinil may have utility as an adjunctive treatment in bipolar I depression.Multicenter, randomized, double-blind study in patients aged 18 to 65 years experiencing a depressive episode despite maintenance therapy for bipolar I disorder. Patients were randomized to receive adjunctive armodafinil 150 mg/day or adjunctive placebo for 8 weeks. Primary efficacy outcome was change from baseline in 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) total score at week 8. Safety and tolerability were monitored.Of 656 patients screened, 399 were randomized, of whom 308 (77 %) were taking a protocol-allowed mood stabilizer as monotherapy. The primary efficacy outcome did not reach statistical significance; however, several secondary efficacy outcomes demonstrated statistically significant advantages for adjunctive armodafinil (n?=?197) over adjunctive placebo (n?=?196), including Clinical Global Impression of Severity of Illness for depression (weeks 6, 8, and endpoint; all P?

View details for DOI 10.1186/s40345-015-0034-0

View details for PubMedID 26330288