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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

Overview of attention for article published in International Journal of Bipolar Disorders, September 2015
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Title
Randomized, placebo-controlled, adjunctive study of armodafinil for bipolar I depression: implications of novel drug design and heterogeneity of concurrent bipolar maintenance treatments
Published in
International Journal of Bipolar Disorders, September 2015
DOI 10.1186/s40345-015-0034-0
Pubmed ID
Authors

Mark A Frye, Jess Amchin, Michael Bauer, Caleb Adler, Ronghua Yang, Terence A Ketter

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 < 0.05), Global Assessment of Functioning (weeks 4, 8, and endpoint; all P < 0.02), IDS-C30 remitter rates (week 8 and endpoint; both P < 0.02), and mean change from baseline in IDS-C30 total score at week 7 (P < 0.05). Adjunctive armodafinil and adjunctive placebo were generally well tolerated. Although adjunctive armodafinil compared with adjunctive placebo yielded a higher headache rate (15 vs 8 %), it yielded similar (generally favorably low) rates of all-cause discontinuation (16 vs 16 %), adverse event discontinuation (4 vs 5 %), nausea (6 vs 4 %), ≥7 % weight gain (2 vs 5 %), anxiety (4 vs 3 %), insomnia (3 vs 2 %), sedation/somnolence (1 vs 1 %), and hypomania (0 vs <1 %). In this study, adjunctive armodafinil compared with adjunctive placebo in bipolar I depression did not separate in the primary efficacy outcome but demonstrated advantages for several secondary efficacy outcomes and was generally well tolerated. Additional research is warranted and necessary to better identify clinical predictors (e.g., atypical depressive symptoms, specific anti-manic/mood-stabilizing agents used) that would provide optimized, individualized therapeutics for bipolar depression. ClinicalTrials.gov: NCT01305408.

Twitter Demographics

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Mendeley readers

The data shown below were compiled from readership statistics for 33 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 33 100%

Demographic breakdown

Readers by professional status Count As %
Student > Bachelor 7 21%
Researcher 6 18%
Other 3 9%
Student > Ph. D. Student 3 9%
Unspecified 2 6%
Other 7 21%
Unknown 5 15%
Readers by discipline Count As %
Medicine and Dentistry 11 33%
Psychology 4 12%
Pharmacology, Toxicology and Pharmaceutical Science 3 9%
Economics, Econometrics and Finance 2 6%
Unspecified 2 6%
Other 4 12%
Unknown 7 21%

Attention Score in Context

This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 04 September 2015.
All research outputs
#11,518,471
of 14,535,828 outputs
Outputs from International Journal of Bipolar Disorders
#156
of 194 outputs
Outputs of similar age
#164,462
of 240,067 outputs
Outputs of similar age from International Journal of Bipolar Disorders
#1
of 1 outputs
Altmetric has tracked 14,535,828 research outputs across all sources so far. This one is in the 11th percentile – i.e., 11% of other outputs scored the same or lower than it.
So far Altmetric has tracked 194 research outputs from this source. They typically receive a little more attention than average, with a mean Attention Score of 7.5. This one is in the 8th percentile – i.e., 8% of its peers scored the same or lower than it.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 240,067 tracked outputs that were published within six weeks on either side of this one in any source. This one is in the 17th percentile – i.e., 17% of its contemporaries scored the same or lower than it.
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