Original article 1
Armodafinil in binge eating disorder: a randomized,
placebo-controlled trial
Susan L. McElroya,b, Anna I. Guerdjikovaa,b, Nicole Moria, Thomas J. Blomb,
Stephanie Williamsa, Leah S. Casutoa,b and Paul E. Keck Jra,b
This study evaluated the efficacy, tolerability, and safety of
armodafinil in the treatment of binge eating disorder (BED).
Sixty participants with BED were randomized to receive
armodafinil (150–250 mg/day) (N = 30) or placebo (N = 30)
in a 10-week, prospective, parallel-group, double-blind,
flexible-dose, single-center trial. In the primary longitudinal
analysis, armodafinil and placebo produced similar rates of
improvement in binge eating day frequency (the primary
outcome measure); however, armodafinil was associated
with a statistically significantly higher rate of decrease in
binge eating episode frequency. In the secondary baseline-
to-endpoint analyses, armodafinil was associated with
statistically significant reductions in obsessive–compulsive
features of binge eating and BMI. The mean (SD)
armodafinil daily dose at endpoint evaluation was 216.7
(43.9) mg. There were no serious adverse events, although
one armodafinil recipient developed markedly increased
Introduction
Binge eating disorder (BED) is characterized by recur-
rent, distressing binge eating episodes without the
inappropriate compensatory weight loss behaviors of
bulimia nervosa (Wonderlich et al., 2009; American
Psychiatric Association, 2013). It is the most common
eating disorder, with an estimated lifetime prevalence of
2–3% (Hudson et al., 2007; Kessler et al., 2013). BED is
associated with psychiatric comorbidity, general medical
comorbidity, including obesity and metabolic dysfunc-
tion, reduced quality of life, and disability (Masheb and
Grilo, 2004; Striegel-Moore et al., 2004; Hudson et al.,
2007, 2010; Kessler et al., 2013). Psychotherapy and
pharmacotherapy reduce binge eating pathology in BED,
but not all patients respond (Reas and Grilo, 2008; Wilson
et al., 2010; Reas and Grilo, 2014). Novel treatments are
therefore needed for BED.
Armodafinil, an active isomer of modafinil, is a
wakefulness-promoting agent approved for the treatment
of excessive sleepiness in patients with obstructive sleep
apnea, narcolepsy, or shift work disorder (Bogan, 2010).
Because BED may involve dopamine (DA) dysfunction
(i.e. enhanced striatal DA release during food stimula-
tion) (Mathes et al., 2009; Wang et al., 2011) and armo-
dafinil binds to the DA transporter and inhibits DA
uptake (Spencer et al., 2010; Loland et al., 2012), we
http://www.clinicaltrials.gov Identifier: NCT01010789.
0268-1315 Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.
Copyright © 2015 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
blood pressure that resolved upon drug discontinuation.
The small sample size may have limited the detection of
important drug–placebo differences. As some of the
observed effect sizes appeared clinically meaningful, larger
studies of armodafinil in the treatment of BED are
warranted. Int Clin Psychopharmacol 00:000–000 Copyright
© 2015 Wolters Kluwer Health, Inc. All rights reserved.
International Clinical Psychopharmacology 2015, 00:000–000
Keywords: armodafinil, binge eating disorder, dopamine
a
Lindner Center of HOPE, Mason and bDepartment of Psychiatry and Behavioral
Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA
Correspondence to Susan L. McElroy, MD, Lindner Center of HOPE, Research
Institute, 4075 Old Western Row Road, Mason, Ohio 45040, USA
Tel: + 1 513 536 0700; fax: + 1 513 536 0709;
e-mail: susan.mcelroy@lindnercenter.org
Received 12 February 2015 Accepted 16 April 2015
carried out a prospective, randomized, parallel-group,
double-blind, placebo-controlled study of armodafinil in
BED. Here, we report the results of that study.
Methods
Patient population
Participants were recruited by radio and newspaper
advertisements and were enrolled if they fulfilled
Diagnostic and Statistical Manual of Mental Disorders,
4th ed. – text revision (DSM-IV-TR) (American
Psychiatric Association, 2000) criteria for BED, had at
least three binge eating days per week for the 2 weeks
before receiving study medication confirmed with pro-
spective diaries, had a BMI of at least 25 mg/kg2, and
were male or female 18 through 65 years of age.
Individuals were excluded from study participation if
they had current anorexia nervosa or bulimia nervosa,
clinically significant suicidality, a substance use disorder
(except nicotine dependence) within 6 months of study
entry, or a lifetime history of psychosis, mania or hypo-
mania, or dementia. Participants were also excluded if
they had a clinically unstable medical illness, clinically
significant laboratory or ECG abnormalities, or had
received any psychotropic medications (other than hyp-
notics) within 4 weeks before randomization. Women
were excluded if they were pregnant, lactating, or, if of
childbearing age, not practicing a medically accepted
form of contraception.
DOI: 10.1097/YIC.0000000000000079
2 International Clinical Psychopharmacology 2015, Vol 00 No 00
The Institutional Review Board at the University of
Cincinnati Medical Center approved the study protocol
and the study was carried out in compliance with the
Declaration of Helsinki. All participants signed approved
written informed consent forms after the study proce-
dures had been fully explained and before any study
procedures were performed. Participants were enrolled
from 18 November 2009 to 15 August 2014.
Study design
This was a prospective, randomized, parallel-group,
double-blind, placebo-controlled, flexible-dose study
carried out at the Lindner Center of HOPE, Mason,
Ohio. The trial consisted of a 2-week screening period; a
10-week double-blind treatment period; and a 1-week
treatment discontinuation period. Participants were
evaluated at least twice during the screening period; after
1, 2, 3, 4, 6, 8, and 10 weeks during the treatment period;
and 1 week after study medication discontinuation.
Screening evaluation included the Structured Clinical
Interview for DSM-IV-TR (First et al., 2007) to establish
BED and comorbid axis I diagnoses; the Eating Disorder
Examination-Questionnaire (Fairburn and Beglin, 1994)
to confirm the diagnosis of BED; a medical history and
physical examination; vital signs; height and weight; an
ECG; routine blood chemical and hematological tests;
and urine drug screen. At this evaluation and at each
subsequent visit, participants received take-home diaries
in which to record any binge eating episodes (see out-
come measures). At the last visit of the screening period
(the baseline assessment), participants continuing to
fulfill entry criteria were assigned randomly to therapy
with armodafinil or placebo. At each visit following the
baseline visit, participants were assessed for the number
of binge eating episodes and binge eating days experi-
enced since the last visit; other outcome measures;
medication compliance ascertained by capsule count;
treatment-emergent adverse events; use of nonstudy
medications; vital signs; and weight.
All study medication was in identically appearing cap-
sules (50 mg of armodafinil or matching placebo) sup-
plied in numbered containers and dispensed to
participants according to a predetermined randomization
schedule. Study medication was started at 150 mg/day,
taken as three capsules in the morning. If the patient had
not stopped binge eating after 4 weeks of treatment,
study medication was increased to 250 mg/day, taken as
five capsules in the morning. Study medication could be
reduced back to a minimum of 150 mg/day because of
side effects during the subsequent 6 weeks of treatment.
Participants were randomized to receive armodafinil or
placebo in a 1 : 1 ratio according to computer-generated
coding. Randomization was balanced using permuted
blocks. Allocation concealment was achieved by having
research pharmacy personnel perform the randomization,
Copyright © 2015 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
package the study medication, and maintain the integrity
of the blinded information throughout the trial.
Outcome measures
The primary efficacy outcome was the weekly frequency
of binge eating days (binge eating days/week), defined as
the mean number of binge eating days per week in the
interval between visits (total number of binge eating days
in the interval divided by number of days in the interval,
and then multiplied by 7). A binge eating day was
defined as a day during which the participant had at least
one binge eating episode. Binge eating episodes were
defined using the DSM-IV-TR criteria, and assessed by
clinical interview and review of participant take-home
diaries, on which participants recorded binge eating
episodes, duration of binge eating episodes, and food
consumed during binge eating episodes. Secondary effi-
cacy measures were weekly frequency of binge eating
episodes (binge eating episodes/week); scores on the
Clinical Global Impression-Severity (CGI-S) and
Improvement Scales (CGI-I) (Guy, 1976), Yale-Brown
Obsessive Compulsive Scale modified for Binge Eating
(YBOCS-BE) (Goodman et al., 1989), Eating Inventory
(EI) (Stunkard and Messick, 1985), Brief Fatigue
Inventory (BFI) (Mendoza et al., 1999), Inventory of
Depressive Symptomatology (IDS) (Rush et al., 1996),
and Beck Anxiety Inventory (BAI) (Beck et al., 1988);
weight (kg); and BMI (calculated by dividing body
weight in kg by height in m2). All scales were adminis-
tered at all postbaseline visits, except for the EI, IDS,
and BAI, which were administered at baseline and at
weeks 4, 8, and 10. Weight was obtained at every visit,
assessed with the participant in light clothing without
shoes on the same scale zeroed at each measurement.
Finally, global improvement and 4-week cessation of
binge eating were assessed; these were defined, respec-
tively, as having a CGI-I of 1 or 2 (very much or much
improved) at endpoint and as having no binge eating
episodes in the last 4 weeks that the participant received
study medication.
Safety measures assessed were treatment-emergent
adverse events, clinical laboratory and ECG data, and
vital signs. Suicidality was monitored using the Columbia-
Suicide Severity Rating Scale (Posner et al., 2011).
Adherence was ascertained with returned capsule count.
Statistical methods
The baseline characteristics of each group were com-
pared using χ2 or Fisher’s exact test for categorical vari-
ables and independent-samples t-tests or Wilcoxon rank
sum tests for continuous variables. SAS software (version
9.2; SAS Institute Inc., Cary, North Carolina, USA) was
used to carry out all analyses. Statistical assessments of
outcome variables were performed with the full analysis
set (all randomized participants taking ≥ 1 study drug
dose and having ≥ 1 postbaseline efficacy assessment).

Safety and tolerability assessments were performed in the
safety analysis set (all randomized patients taking ≥ 1
study drug dose and having ≥ 1 postbaseline safety
assessment). All statistical tests and confidence intervals
were two-sided, with a significance level of 0.05.
The statistical methods used were similar to those used
in other pharmacotherapy trials in BED (Hudson et al.,
1998; McElroy et al., 2000, 2003a, 2003b, 2006, 2007a,
2007b; Arnold et al., 2002; Appolinario et al., 2003;
Guerdjikova et al., 2008, 2009, 2012; Wilfley et al., 2008).
The primary efficacy analysis was a longitudinal analysis
comparing the rate of change of binge eating days/week
during the treatment period between groups. The same
analysis was applied to the secondary outcomes. The
difference in the rate of change was estimated by random
regression methods, as described in the study by Gibbons
et al. (1993) and Fitzmaurice et al. (2004). We used a
model for the mean of the outcome variable that included
terms for treatment, time, and treatment-by-time inter-
action. Time was modeled as a continuous variable,
expressed as the square root of days since randomization
(baseline). For the analyses of binge eating day fre-
quency and binge eating episode frequency, we used the
logarithmic transformations log [(binge days/week) + 1]
and log [(binges/week + 1)], respectively, to normalize
the data and stabilize the variance. In addition, log
transformations were used on other outcome measures
when appropriate. To simultaneously account for indi-
vidual differences in the initial level of the outcome, rate
of change over time, and serial autocorrelation, we used
the SAS procedure MIXED. These mixed models
included random coefficients for the intercept and time
variables. The best-fitting correlation structure for the
error terms, as determined by the lowest AIC value, was
chosen for each model from compound symmetric, first-
order antedependence, and first-order autoregressive
forms. The longitudinal analyses included all available
observations from all participants in the full analysis set.
Several secondary analyses were carried out. Using the
last observation carried forward, baseline-to-endpoint
change scores were computed for each measure and
independent-sample t-tests or Wilcoxon rank sum tests
were used to compare these changes between the treat-
ment groups. Fisher’s exact tests or χ2 tests were used to
analyze categorical response to treatment and adverse
events. For laboratory measures, the mean difference
between endpoint and baseline measures was computed
for each treatment group and then compared using
independent-sample t-tests or Wilcoxon rank sum tests.
Results
Of 139 individuals assessed for eligibility, 60 fulfilled the
entry criteria and were randomized to armodafinil
(N = 30) or placebo (N = 30) (Fig. 1). Of these 60 parti-
cipants, 51 (85%) were women, 46 (77%) were White, and
Copyright © 2015 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
Armodafinil in binge eating disorder McElroy et al. 3
the mean (SD) baseline weekly binge eating day fre-
quency was 4.4 (1.2) (Table 1). Lifetime depressive
disorders were the most common comorbid psychiatric
disorders, occurring in 12 (20%) of participants. The two
treatment groups were well matched in demographic and
clinical variables at baseline (Table 1). Thirty-one parti-
cipants (16 receiving armodafinil and 15 receiving pla-
cebo, P = 0.80) completed the 10-week treatment period
(Fig. 1). The mean (SD) daily dose of armodafinil at
endpoint evaluation was 216.7 (43.9) mg; for placebo, it
was 208.9 (62.4) mg.
The mean binge eating day frequency decreased over
the study period in both treatment groups, but the rate of
reduction was similar for armodafinil recipients and pla-
cebo recipients (Table 2 and Fig. 2). However, compared
with placebo, armodafinil was associated with a statisti-
cally significantly higher rate of reduction in binge eating
episode frequency (Table 2 and Fig. 3). There were no
statistically significant differences between groups on
change in CGI-S, YBOCS-BE, EI, BFI, IDS, or BAI
scores; weight; or BMI.
In the secondary analyses of baseline-to-endpoint change
scores, armodafinil was associated with statistically sig-
nificant decreases in YBOCS-BE total scores and in BMI
compared with placebo (Table 2). The associated stan-
dardized effect sizes were moderate in range (Cohen’s
D = 0.60 and 0.60, respectively).
For categorical response, numerically more patients in
the armodafinil group showed at least a moderate
improvement on the CGI-I at endpoint [21 (78%)]
compared with placebo recipients [15 (54%)], but this
difference was not statistically significant (P = 0.06).
Armodafinil was not associated with a statistically sig-
nificantly higher 4-week binge eating cessation rate (26
vs. 21% for placebo, P = 0.69).
Feeling jittery and dry mouthed were significantly more
common with armodafinil than placebo (Table 3). Two
participants discontinued armodafinil and two dis-
continued placebo because of adverse events. For
armodafinil, these were excessive fatigue and anxiety in
one patient and elevated blood pressure (from
128/64 mmHg at baseline to 210/100 mmHg after 2 days
of treatment) in another. The patient’s elevated blood
pressure was treated successfully with intravenous labe-
talol in an emergency room and by discontinuation of
armodafinil. Adverse events leading to placebo dis-
continuation were abdominal cramping and worsening of
depressive symptoms.
Armodafinil was associated with a statistically significant
increase in pulse at the last visit compared with change in
the placebo group (5.5 vs. − 2.6 beats/min, respectively,
P = 0.02). Two patients developed tachycardia (each
105 bpm). In both cases, the tachycardia was asympto-
matic and transient. There were no significant differences
4 International Clinical Psychopharmacology 2015, Vol 00 No 00

Fig. 1

139 individuals assessed for eligibility

60 individuals randomized 79 individuals not randomized

(a) 54 did not meet entry criteria
(b) 25 chose not to participate

30 assigned to armodafinil 30 assigned to placebo

(a) 27 full analysis seta (a) 28 full analysis seta
(b) 28 safety analysis setb (b) 29 safety analysis setb

14 discontinued 15 discontinued
(a) Adverse event (2) (a) Adverse event (2)
(b) Personal reasons (1) (b) Personal reasons (3)
(c) Lost to follow-up (8) (c) Lost to follow-up (3)
(d) Lack of efficacy (1) (d) Lack of efficacy (2)
(e) Study nonadherence (2) (e) Study nonadherence (3)
(f) Onset of new medical condition (2)

16 completed double-blind treatment 15 completed double-blind treatment

Participants who entered a 10-week, randomized, placebo-controlled trial of armodafinil in binge eating disorder. aFull analysis set defined as all
randomized participants who received at least study medication dose and had at least postbaseline efficacy assessment. bSafety population defined
as all randomized participants who received at least one dose of study medication and for whom at least one postbaseline safety measure was
available.

Table 1 Demographic and clinical characteristics at baselinea

Total (n = 60) Armodafinil (n = 30) Placebo (n = 30) P-valueb
Sex (female) [n (%)] 51 (85) 28 (93) 23 (77) 0.15
Age (years) 41.3 (12.0) 40.8 (12.7) 41.9 (11.4) 0.73
Race [n (%)] 0.76
White 46 (77) 22 (73) 24 (80)
African-American 14 (23) 8 (27) 6 (20)
Binge days per week 4.4 (1.2) 4.5 (1.5) 4.4 (1.0) 0.63
Binge episodes per week 5.4 (2.5) 5.9 (4.8) 5.0 (1.6) 0.14
CGI-severity 4.8 (0.8) 4.8 (0.9) 4.9 (0.7) 0.87
BED age onset 24.0 (12.9) 22.8 (12.1) 25.1 (13.7) 0.49
Lifetime depressive disorder [n (%)] 12 (20) 6 (20) 6 (20) 1.00
Lifetime anxiety disorder [n (%)] 4 (7) 1 (3) 3 (10) 0.61
Lifetime substance use disorder [n (%)] 0 (0) 0 (0) 0 (0) NA
YBOCS-BE total 20.8 (4.1) 21.2 (3.7) 20.4 (4.5) 0.45
EI-restraint 6.8 (4.1) 7.0 (4.4) 6.5 (3.8) 0.62
EI-disinhibition 13.4 (2.0) 13.7 (1.5) 13.1 (2.4) 0.25
EI-hunger 11.4 (2.8) 11.4 (3.1) 11.4 (2.5) 1.00
BFI 36.4 (20.0) 34.0 (21.4) 38.7 (18.6) 0.38
IDS 16.9 (9.5) 15.4 (9.5) 18.5 (9.4) 0.21
BAI 6.6 (5.9) 5.7 (6.4) 7.5 (5.3) 0.04
Weight (kg) 110.0 (25.2) 108.3 (25.0) 113.6 (25.6) 0.42
BMI (kg/m2) 40.1 (8.0) 39.7 (9.1) 40.4 (7.0) 0.74
Obesity (BMI ≥ 30) [n (%)] 55 (92) 27 (90) 28 (93) 1.00

BAI, Beck Anxiety Inventory; BED, binge eating disorder; BFI, Brief Fatigue Inventory; CGI, Clinical Global Impression; EI, Eating Inventory; IDS, Inventory of Depressive
Symptomatology; NA, not applicable; YBOCS-BE, Yale-Brown Obsessive Compulsive Scale modified for Binge Eating.
a
Mean (SD) or n (%) shown.
b
Fisher’s exact tests, t-tests, or Wilcoxon rank sum tests.

between armodafinil-treated patients and those adminis- n = 35), except that armodafinil was associated with
tered placebo in mean change from baseline to final visit decreased glucose (− 2.5 vs. 13.5 mg/dl, P = 0.02) and
for blood pressure and laboratory values (laboratory data, increased sodium (0.88 vs. − 0.35 mmol/l, P = 0.02)

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 Armodafinil in binge eating disorder McElroy et al. 5

Table 2 Primary (longitudinal) and secondary (endpoint) analyses of each outcome measure
Estimated difference between groups at 10 weeks (n = 55)
Change (endpoint − baseline) Armodafinil change from BL − placebo change from BL [95% CI]

Armodafinil (n = 27) Placebo (n = 28) Longitudinal analysis P-value Endpoint analysis P-value da
Binge days per week − 3.1 (2.1) − 2.4 (1.6) 0.78 [0.55–1.10]b 0.15 − 0.7 [ − 1.7 to 0.3] 0.16 0.38
Binge episodes per week − 4.2 (3.1) − 2.8 (1.8) 0.71 [0.51–1.00]b 0.05 − 1.3 [ − 2.7 to 0.0] 0.06 0.52
CGI-severity − 2.3 (1.7) − 1.5 (1.5) − 0.7 [ − 1.6 to 0.2] 0.14 − 0.8 [ − 1.7 to 0.1] 0.07 0.51
YBOCS-BE total − 12.5 (6.9) − 8.5 (6.4) − 3.1 [ − 6.6 to 0.5] 0.09 − 4.0 [ − 7.6 to − 0.4] 0.03 0.60
EI-restraint 2.7 (5.2) 2.4 (4.6) 0.5 [ − 2.5 to 3.5] 0.76 0.3 [ − 2.6 to 3.2] 0.84 − 0.06
EI-disinhibition − 2.9 (4.6) − 1.8 (3.9) − 1.3 [ − 4.0 to 1.5] 0.36 − 1.1 [ − 3.6 to 1.4] 0.37 0.26
EI-hunger − 3.7 (3.4) − 2.7 (3.8) − 1.4 [ − 3.6 to 0.9] 0.23 − 1.0 [ − 3.1 to 1.1] 0.35 0.28
BFI − 16.7 (24.3) − 15.9 (17.2) 0.66 [0.34–1.30]b 0.35 − 0.8 [ − 12.1 to 10.6] 0.89 0.04
IDS − 5.4 (6.9) − 5.5 (7.9) 0.99 [0.64–1.52]b 0.95 0.1 [ − 4.2 to 4.4] 0.96 − 0.01
BAI − 1.1 (6.0) − 1.1 (5.9) 1.18 [0.63–2.2]b 0.60 − 0.1 [ − 3.5 to 3.4] 0.97 0.02
Weight (kg) − 1.6 (2.4) 0.0 (3.6) 0.98 [0.97–1.0]b 0.08 − 1.6 [ − 3.3 to 0.0] 0.06 0.52
BMI (kg/m2) − 0.6 (0.8) 0.1 (1.2) 0.98 [0.97–1.0]b 0.07 − 0.6 [ − 1.2 to − 0.1] 0.03 0.58

BAI, Beck Anxiety Inventory; BFI, Brief Fatigue Inventory; BL, baseline; CGI, Clinical Global Impression; CI, confidence interval; EI, Eating Inventory; IDS, Inventory of
Depressive Symptomatology; YBOCS-BE, Yale-Brown Obsessive Compulsive Scale modified for Binge Eating.
a
Cohen’s effect size; positive values indicate a greater reduction in the armodafinil group.
b
Log transformation used; estimate equals ratio of (Armweek 10/Armbaseline) to (Placeboweek10/Placebobaseline).

Fig. 2 Fig. 3

7 5

4.5
6 Armodafinil Armodaf inil
Placebo
4
Placebo
5
Binge eating episodes

3.5
Binge eating days

3
4
2.5
3
2

2 1.5

1
1
0.5
0 0
0 1 2 3 4 5 6 7 8 9 10 0 1 2 3 4 5 6 7 8 9 10
Study week Study week

Weekly mean binge eating episodes by treatment group. Weekly mean binge eating days by treatment group.

associated with statistically significant decreases in

compared with the change in the placebo group. There
obsessive–compulsive features of binge eating and BMI.
were no instances of hypernatremia (serum sodium ≥146
mmol/l). There were no serious adverse events, no These findings provide preliminary evidence that armo-
instances of ECG abnormalities or suicidality, no indica- dafinil may have some clinical utility in BED, at least for
tions of misuse, and no discontinuation symptoms. the short-term reduction of binge eating episode fre-
quency, obsessive–compulsive features of binge eating,
and BMI. Taken together, these clinical findings are in
Discussion agreement with research findings of central DA dysre-
In the primary longitudinal analysis of this 10-week, gulation in BED (Mathes et al., 2009; Wang et al., 2011)
randomized trial in 60 individuals with BED, armodafinil and with clinical trial results suggesting that enhance-
was not significantly superior to placebo in reducing ment of DA function may exert therapeutic effects in
binge eating day frequency. However, compared with BED (McElroy et al., 2015). That one participant
placebo, armodafinil was associated with a significantly developed severely elevated blood pressure with armo-
greater reduction in binge eating episode frequency. In dafinil and that pulse was significantly increased in
secondary baseline-to-endpoint analyses, armodafinil was armodafinil recipients compared with placebo recipients,

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6 International Clinical Psychopharmacology 2015, Vol 00 No 00

Table 3 Treatment-emergent adverse events occurring in at least Acknowledgements

three participants
The authors acknowledge Genie Groff for manuscript
n (%) preparation.
Total Armodafinil Placebo The study was supported by a grant from Teva
Adverse event (n = 60) (n = 30) (n = 30) P-valuea
Pharmaceuticals.
Headache 25 (42) 15 (50) 10 (33) 0.29
Insomnia 22 (37) 13 (43) 9 (30) 0.42
Nausea 11 (18) 7 (23) 4 (13) 0.51 Conflicts of interest
Feeling jittery 9 (15) 9 (30) 0 (0) < 0.01
Dry mouth 8 (13) 7 (23) 1 (3) 0.05
Dr Susan McElroy is a consultant to or member of the
Anxiety 5 (8) 3 (10) 2 (7) 1.00 scientific advisory boards of Bracket, F. Hoffmann-La
Fatigue 5 (8) 1 (3) 4 (13) 0.35 Roche Ltd, MedAvante, Myriad, Naurex, Novo Nordisk,
Diarrhea/abnormal 5 (8) 2 (7) 3 (10) 1.00
stool Shire, and Sunovion. She is a principal or coinvestigator
Disturbance in 4 (7) 2 (7) 2 (7) 1.00 on studies sponsored by the Agency for Healthcare
attention
Research & Quality (AHRQ), Alkermes, Cephalon,
Hot flashes 4 (7) 3 (10) 1 (3) 0.61
Irritability 4 (7) 0 (0) 4 (13) 0.11 Forest, Marriott Foundation, National Institute of Mental
Abnormal/vivid 3 (5) 2 (7) 1 (3) 1.00 Health, Naurex, Orexigen Therapeutics Inc., Shire, and
dreams
Dizziness 3 (5) 1 (3) 2 (7) 1.00
Takeda Pharmaceutical Company Ltd. She is also an
Somnolence 3 (5) 2 (7) 1 (3) 1.00 inventor on United States Patent No. 6,323,236 B2, Use
a of Sulfamate Derivatives for Treating Impulse Control
Fisher’s exact test.
Disorders, and along with the patent’s assignee,
University of Cincinnati, Cincinnati, Ohio, has received
payments from Johnson & Johnson, which has exclusive
however, indicates that further studies of armodafinil in rights under the patent. Dr Paul Keck is a consultant to,
this patient population will need to carefully monitor or member of the scientific advisory boards, and/or a
cardiovascular parameters. Indeed, armodafinil may cause principal or coinvestigator on research studies sponsored
modest increases in pulse and blood pressure in patients by Alkermes, Forest, Cephalon, Marriott Foundation,
with excessive sleepiness (Black et al., 2010; Bogan, National Institute of Mental Health (NIMH), Shire, and
2010). Sunovion. He is also inventor on United States Patent
No. 6,387,956: Shapira NA, Goldsmith TD, Keck, PE Jr.
Several limitations of this study should be considered. (University of Cincinnati) Methods of treating
First, the small sample size may have compromised the obsessive–compulsive spectrum disorder comprises the
ability of the study to detect clinically important ther- step of administering an effective amount of tramadol to
apeutic or adverse effects. Second, the attrition rate was an individual. Filed 25 March 1999; approved 14 May
high (48% of patients withdrew before study completion) 2002. For the remaining authors there are no conflicts of
and the results may not be consistent with armodafinil’s interest.
effects after 10 weeks of treatment. However, dropouts
did not vary by treatment group, demographics, or
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