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
Mark A FryeTerence 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 tot...Continue Reading

References

Nov 1, 1978·The British Journal of Psychiatry : the Journal of Mental Science·R C YoungD A Meyer
Jun 5, 2002·Archives of General Psychiatry·Lewis L JuddMartin B Keller
Nov 24, 2004·The Journal of Clinical Psychiatry·Joseph R CalabreseMichael L Reed
Jun 9, 2005·Archives of General Psychiatry·Ronald C KesslerEllen E Walters
May 9, 2007·Archives of General Psychiatry·Kathleen R MerikangasRonald C Kessler
Aug 3, 2007·The American Journal of Psychiatry·Mark A FryeRobert M Post
Jan 22, 2008·Journal of Clinical Psychopharmacology·Michael E ThaseRandall Owen
Feb 1, 2011·Psychiatry Research·Goran TrajkovićJelena Marinković
Mar 9, 2011·Archives of General Psychiatry·Kathleen R MerikangasZahari Zarkov
May 2, 2015·Journal of Affective Disorders·Terence A KetterMark A Frye

❮ Previous
Next ❯

Citations

Mar 13, 2016·Journal of Affective Disorders·Terence A KetterNicholas Gross
Jul 21, 2016·Journal of Clinical Pharmacology·Susan WillavizeLingling Guan
Mar 4, 2017·Acta Psychiatrica Scandinavica·A G SzmulewiczS A Strejilevich
Feb 26, 2016·The Australian and New Zealand Journal of Psychiatry·Gin S MalhiGreg Murray
Nov 4, 2016·The Australian and New Zealand Journal of Psychiatry·Ulrich Hegerl, Tilman Hensch
Mar 11, 2016·British Journal of Hospital Medicine·Kate E A Saunders, John R Geddes
Jan 25, 2018·Expert Opinion on Pharmacotherapy·Anne Michal MorselBernard Sabbe
Jul 2, 2020·Neuropsychiatric Disease and Treatment·Nefize Yalin, Allan H Young
Dec 3, 2016·International Journal of Bipolar Disorders·Michael Gitlin
Feb 23, 2021·Expert Opinion on Pharmacotherapy·Ahmad Sleem, Rif S El-Mallakh
Aug 28, 2021·Life·Hosna Mohammad SadeghiMohammad Abdollahi

❮ Previous
Next ❯

Clinical Trials Mentioned

NCT01305408
NCT01072929
NCT01072630

Software Mentioned

Nuvigil

Related Concepts

Related Feeds

Bipolar Disorder

Bipolar disorder is characterized by manic and/or depressive episodes and associated with uncommon shifts in mood, activity levels, and energy. Discover the latest research this illness here.

Antipsychotic Drugs

Antipsychotic drugs are a class of medication primarily used to manage psychosis (including delusions, hallucinations, paranoia or disordered thought), principally in schizophrenia and bipolar disorder. Discover the latest research on antipsychotic drugs here