PMID- 26970266
OWN - NLM
STAT- MEDLINE
DCOM- 20161213
LR  - 20181202
IS  - 1573-2517 (Electronic)
IS  - 0165-0327 (Linking)
VI  - 197
DP  - 2016 Jun
TI  - Long-term safety and efficacy of armodafinil in bipolar depression: A 6-month 
      open-label extension study.
PG  - 51-7
LID - S0165-0327(15)30779-5 [pii]
LID - 10.1016/j.jad.2016.02.050 [doi]
AB  - BACKGROUND: 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. METHODS: 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). RESULTS: 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. LIMITATIONS: Lack of placebo control. CONCLUSIONS: 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.
CI  - Copyright (c) 2016 Elsevier B.V. All rights reserved.
FAU - Ketter, Terence A
AU  - Ketter TA
AD  - Stanford University School of Medicine, Stanford, CA, USA. Electronic address: 
      tketter@stanford.edu.
FAU - Amchin, Jess
AU  - Amchin J
AD  - Teva Pharmaceuticals, Frazer, PA, USA.
FAU - Frye, Mark A
AU  - Frye MA
AD  - Mayo Clinic, Rochester, MN, USA.
FAU - Gross, Nicholas
AU  - Gross N
AD  - Teva Pharmaceuticals, Frazer, PA, USA.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20160227
PL  - Netherlands
TA  - J Affect Disord
JT  - Journal of affective disorders
JID - 7906073
RN  - 0 (Benzhydryl Compounds)
RN  - 0 (Wakefulness-Promoting Agents)
RN  - R3UK8X3U3D (Modafinil)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Anxiety/chemically induced
MH  - Benzhydryl Compounds/*administration & dosage/*adverse effects
MH  - Bipolar Disorder/diagnosis/*drug therapy
MH  - Double-Blind Method
MH  - Female
MH  - Headache/chemically induced
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Modafinil
MH  - Sleep Initiation and Maintenance Disorders/chemically induced
MH  - Treatment Outcome
MH  - Wakefulness-Promoting Agents/*administration & dosage/*adverse effects
OTO - NOTNLM
OT  - Armodafinil
OT  - Bipolar I disorder
OT  - Bipolar depression
OT  - Long-term safety
OT  - Wakefulness
EDAT- 2016/03/13 06:00
MHDA- 2016/12/15 06:00
CRDT- 2016/03/13 06:00
PHST- 2015/08/14 00:00 [received]
PHST- 2016/02/16 00:00 [revised]
PHST- 2016/02/25 00:00 [accepted]
PHST- 2016/03/13 06:00 [entrez]
PHST- 2016/03/13 06:00 [pubmed]
PHST- 2016/12/15 06:00 [medline]
AID - S0165-0327(15)30779-5 [pii]
AID - 10.1016/j.jad.2016.02.050 [doi]
PST - ppublish
SO  - J Affect Disord. 2016 Jun;197:51-7. doi: 10.1016/j.jad.2016.02.050. Epub 2016 Feb 
      27.