EurekaMag.com logo
+ Site Statistics
References:
53,869,633
Abstracts:
29,686,251
+ Search Articles
+ Subscribe to Site Feeds
EurekaMag Most Shared ContentMost Shared
EurekaMag PDF Full Text ContentPDF Full Text
+ PDF Full Text
Request PDF Full TextRequest PDF Full Text
+ Follow Us
Follow on FacebookFollow on Facebook
Follow on TwitterFollow on Twitter
Follow on LinkedInFollow on LinkedIn

+ Translate

Long-term safety and efficacy of armodafinil in bipolar depression: A 6-month open-label extension study



Long-term safety and efficacy of armodafinil in bipolar depression: A 6-month open-label extension study



Journal of Affective Disorders 197(): 51-57



Safe/well-tolerated treatments for bipolar I depression remain limited. We assessed safety/tolerability of adjunctive open-label armodafinil, a wakefulness-promoting agent evaluated in 3 acute, controlled efficacy studies with variable efficacy results. Completers of three 8-week, double-blind, placebo-controlled adjunctive armodafinil studies (150-200 mg/day added to ongoing stable maintenance doses of 1 or 2 protocol-defined mood stabilizers) in bipolar I depression could enter this 6-month, open-label extension study. Objectives included evaluation of safety/tolerability (primary) and efficacy (secondary). 867 patients enrolled; 863 received ≥1 dose of armodafinil and 506 (58%) completed the 6-month study. Headache, insomnia, and anxiety were the most common adverse events (AEs) reported, whereas akathisia, nausea, sedation/somnolence, and weight increase were uncommon. Mean measures assessing emergence of mania, anxiety, insomnia, or suicidality showed no worsening. Discontinuations due to AEs occurred in 57 (7%) patients. Serious AEs occurred in 27 (3%) patients and were considered treatment-related in 8 (1%) patients. Depressive symptoms improved over the 6 months, as did patient functioning. Lack of placebo control. Adjunctive armodafinil was generally safe and well tolerated over 6 months of open-label treatment at 150-200 mg/day when taken with protocol-defined mood stabilizers for bipolar I depression. This 6-month open-label study suggested that armodafinil augmentation of bipolar maintenance therapies may have a favorable risk profile and may improve depressive symptoms in some patients with bipolar I depression.

(PDF emailed within 0-6 h: $19.90)

Accession: 058235927

Download citation: RISBibTeXText

PMID: 26970266

DOI: 10.1016/j.jad.2016.02.050



Related references

The long-term tolerability and efficacy of armodafinil in patients with excessive sleepiness associated with treated obstructive sleep apnea, shift work disorder, or narcolepsy: an open-label extension study. Journal of Clinical Sleep Medicine 6(5): 458-466, 2010

Long-term safety and effectiveness of lurasidone in schizophrenia: a 22-month, open-label extension study. Cns Spectrums 21(5): 393-402, 2016

Long-term safety of abobotulinumtoxinA for the treatment of glabellar lines: results from a 36-month, multicenter, open-label extension study. Dermatologic Surgery 40(2): 176-183, 2014

Tolerability and efficacy of armodafinil in naïve patients with excessive sleepiness associated with obstructive sleep apnea, shift work disorder, or narcolepsy: a 12-month, open-label, flexible-dose study with an extension period. Journal of Clinical Sleep Medicine 6(5): 450-457, 2010

Long-term efficacy and safety of ezetimibe 10 mg in patients with homozygous sitosterolemia: a 2-year, open-label extension study. International Journal of Clinical Practice 62(10): 1499-1510, 2008

Tofacitinib, an oral Janus kinase inhibitor, for the treatment of chronic plaque psoriasis: Long-term efficacy and safety results from 2 randomized phase-III studies and 1 open-label long-term extension study. Journal of the American Academy of Dermatology 74(5): 841-850, 2016

Long-Term Efficacy, Safety, and Pharmacokinetics of Drisapersen in Duchenne Muscular Dystrophy: Results from an Open-Label Extension Study. Plos One 11(9): E0161955-E0161955, 2016

Sustained efficacy and long-term safety of oxcarbazepine: One-year open-label extension of a study in refractory partial epilepsy. Epilepsia 44(9): 1160-1165, September, 2003

Long-term safety and efficacy of clobazam for Lennox-Gastaut syndrome: interim results of an open-label extension study. Epilepsy & Behavior 25(4): 687-694, 2013

Open-label study of the long-term efficacy and safety of pramipexole in patients with Restless Legs Syndrome (extension of the PRELUDE study). Sleep Medicine 9(5): 537-541, 2008

Two-year, long-term, open-label extension study of efficacy and safety of oxcarbazepine in patients with uncontrolled partial-onset seizures. Epilepsia 43(Supplement 7): 200, 2002

Multicenter, open-label study of the long-term safety and efficacy of RAD used in combination with Simulect , corticosteroids and Neoral in renal transplantation 6 Month results. Journal of the American Society of Nephrology 11(Program and Abstract Issue): 685A, September, 2000

Long-term efficacy and safety profile of rilonacept in the treatment of cryopryin-associated periodic syndromes: results of a 72-week open-label extension study. Clinical Therapeutics 34(10): 2091-2103, 2013