Adjunctive armodafinil for major depressive episodes associated with bipolar i disorder

Terence A. Ketter, Ronghua Yang, Mark A Frye

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

Background In a previous study, adjunctive armodafinil 150 mg/day significantly improved depressive symptoms associated with bipolar I disorder. Methods Multicenter, double-blind study of patients with a major depressive episode despite bipolar I disorder maintenance therapy randomized to adjunctive placebo or adjunctive armodafinil 150 or 200 mg/day for 8 weeks; for logistical reasons, assignment to armodafinil 200 mg/day was discontinued early. Primary efficacy was measured by change from baseline to week 8 in 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C<inf>30</inf>) total score. Results Patients were randomized to adjunctive placebo (n=230), adjunctive armodafinil 150 mg/day (n=232), or adjunctive armodafinil 200 mg/day (n=30; analyzed for safety only). Least-square mean change in IDS-C<inf>30</inf> total score was numerically superior for adjunctive armodafinil 150 mg/day vs adjunctive placebo, but was not statistically significant (p=0.13). Armodafinil was well-tolerated. Adverse events (AEs) observed in >5% with adjunctive armodafinil 150 mg/day and more frequently than with adjunctive placebo were headache (16% [38/231] vs 13% [30/229]) and nausea (7% [17/231] vs 2% [5/229]). The most common AEs with adjunctive armodafinil 200 mg/day were diarrhea and dry mouth (17% [5/30] each vs 6% [13/229] and 1% [3/229], respectively, with adjunctive placebo). Limitations Early study discontinuation for logistical reasons by the sponsor limited adjunctive armodafinil 200-mg/day assessment. Conclusions FDA-approved bipolar I depression treatments are limited. Adjunctive armodafinil 150 mg/day reduced depressive symptoms associated with bipolar I disorder to a greater extent than adjunctive placebo, although the difference failed to reach statistical significance. Safety data indicate treatment with adjunctive armodafinil was well-tolerated.

Original languageEnglish (US)
Pages (from-to)87-91
Number of pages5
JournalJournal of Affective Disorders
Volume181
DOIs
StatePublished - Aug 1 2015

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Bipolar Disorder
Placebos
armodafinil
Depression
Safety
Least-Squares Analysis
Double-Blind Method
Nausea
Headache
Mouth
Diarrhea
Therapeutics
Equipment and Supplies

Keywords

  • Armodafinil
  • Bipolar I disorder
  • Major depressive episodes

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Clinical Psychology

Cite this

Adjunctive armodafinil for major depressive episodes associated with bipolar i disorder. / Ketter, Terence A.; Yang, Ronghua; Frye, Mark A.

In: Journal of Affective Disorders, Vol. 181, 01.08.2015, p. 87-91.

Research output: Contribution to journalArticle

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title = "Adjunctive armodafinil for major depressive episodes associated with bipolar i disorder",
abstract = "Background In a previous study, adjunctive armodafinil 150 mg/day significantly improved depressive symptoms associated with bipolar I disorder. Methods Multicenter, double-blind study of patients with a major depressive episode despite bipolar I disorder maintenance therapy randomized to adjunctive placebo or adjunctive armodafinil 150 or 200 mg/day for 8 weeks; for logistical reasons, assignment to armodafinil 200 mg/day was discontinued early. Primary efficacy was measured by change from baseline to week 8 in 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) total score. Results Patients were randomized to adjunctive placebo (n=230), adjunctive armodafinil 150 mg/day (n=232), or adjunctive armodafinil 200 mg/day (n=30; analyzed for safety only). Least-square mean change in IDS-C30 total score was numerically superior for adjunctive armodafinil 150 mg/day vs adjunctive placebo, but was not statistically significant (p=0.13). Armodafinil was well-tolerated. Adverse events (AEs) observed in >5{\%} with adjunctive armodafinil 150 mg/day and more frequently than with adjunctive placebo were headache (16{\%} [38/231] vs 13{\%} [30/229]) and nausea (7{\%} [17/231] vs 2{\%} [5/229]). The most common AEs with adjunctive armodafinil 200 mg/day were diarrhea and dry mouth (17{\%} [5/30] each vs 6{\%} [13/229] and 1{\%} [3/229], respectively, with adjunctive placebo). Limitations Early study discontinuation for logistical reasons by the sponsor limited adjunctive armodafinil 200-mg/day assessment. Conclusions FDA-approved bipolar I depression treatments are limited. Adjunctive armodafinil 150 mg/day reduced depressive symptoms associated with bipolar I disorder to a greater extent than adjunctive placebo, although the difference failed to reach statistical significance. Safety data indicate treatment with adjunctive armodafinil was well-tolerated.",
keywords = "Armodafinil, Bipolar I disorder, Major depressive episodes",
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N2 - Background In a previous study, adjunctive armodafinil 150 mg/day significantly improved depressive symptoms associated with bipolar I disorder. Methods Multicenter, double-blind study of patients with a major depressive episode despite bipolar I disorder maintenance therapy randomized to adjunctive placebo or adjunctive armodafinil 150 or 200 mg/day for 8 weeks; for logistical reasons, assignment to armodafinil 200 mg/day was discontinued early. Primary efficacy was measured by change from baseline to week 8 in 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) total score. Results Patients were randomized to adjunctive placebo (n=230), adjunctive armodafinil 150 mg/day (n=232), or adjunctive armodafinil 200 mg/day (n=30; analyzed for safety only). Least-square mean change in IDS-C30 total score was numerically superior for adjunctive armodafinil 150 mg/day vs adjunctive placebo, but was not statistically significant (p=0.13). Armodafinil was well-tolerated. Adverse events (AEs) observed in >5% with adjunctive armodafinil 150 mg/day and more frequently than with adjunctive placebo were headache (16% [38/231] vs 13% [30/229]) and nausea (7% [17/231] vs 2% [5/229]). The most common AEs with adjunctive armodafinil 200 mg/day were diarrhea and dry mouth (17% [5/30] each vs 6% [13/229] and 1% [3/229], respectively, with adjunctive placebo). Limitations Early study discontinuation for logistical reasons by the sponsor limited adjunctive armodafinil 200-mg/day assessment. Conclusions FDA-approved bipolar I depression treatments are limited. Adjunctive armodafinil 150 mg/day reduced depressive symptoms associated with bipolar I disorder to a greater extent than adjunctive placebo, although the difference failed to reach statistical significance. Safety data indicate treatment with adjunctive armodafinil was well-tolerated.

AB - Background In a previous study, adjunctive armodafinil 150 mg/day significantly improved depressive symptoms associated with bipolar I disorder. Methods Multicenter, double-blind study of patients with a major depressive episode despite bipolar I disorder maintenance therapy randomized to adjunctive placebo or adjunctive armodafinil 150 or 200 mg/day for 8 weeks; for logistical reasons, assignment to armodafinil 200 mg/day was discontinued early. Primary efficacy was measured by change from baseline to week 8 in 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30) total score. Results Patients were randomized to adjunctive placebo (n=230), adjunctive armodafinil 150 mg/day (n=232), or adjunctive armodafinil 200 mg/day (n=30; analyzed for safety only). Least-square mean change in IDS-C30 total score was numerically superior for adjunctive armodafinil 150 mg/day vs adjunctive placebo, but was not statistically significant (p=0.13). Armodafinil was well-tolerated. Adverse events (AEs) observed in >5% with adjunctive armodafinil 150 mg/day and more frequently than with adjunctive placebo were headache (16% [38/231] vs 13% [30/229]) and nausea (7% [17/231] vs 2% [5/229]). The most common AEs with adjunctive armodafinil 200 mg/day were diarrhea and dry mouth (17% [5/30] each vs 6% [13/229] and 1% [3/229], respectively, with adjunctive placebo). Limitations Early study discontinuation for logistical reasons by the sponsor limited adjunctive armodafinil 200-mg/day assessment. Conclusions FDA-approved bipolar I depression treatments are limited. Adjunctive armodafinil 150 mg/day reduced depressive symptoms associated with bipolar I disorder to a greater extent than adjunctive placebo, although the difference failed to reach statistical significance. Safety data indicate treatment with adjunctive armodafinil was well-tolerated.

KW - Armodafinil

KW - Bipolar I disorder

KW - Major depressive episodes

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