This is part 1 of a two-part, special edition of Med Check featuring
new research posters presented at APA's 2008 annual meeting in Washington,
D.C., in May.
New research poster presentations are usually preliminary in nature
and often involve results that have not been peer reviewed for publication. In
addition, reports may involve the use of medications for indications that the
Food and Drug Administration has not approved, and they are largely funded by
• Citalopram, a selective serotonin reuptake inhibitor (SSRI), and
RU486, a glucocorticoid antagonist also known as mifepristone, may boost the
resistance of macrophages to HIV infection. Researchers at the University of
Pennsylvania Department of Psychiatry and Children's Hospital of Philadelphia,
led by Tami Benton, M.D., recruited 36 HIV-positive women with and without
depression, obtained their blood samples, and isolated mononuclear cells to
generate macrophages. The macrophages were treated with citalopram or RU486 as
test conditions and then exposed to a strain of HIV.
Macrophages treated wit h either citalopram or RU486 had a significantly
lower rate of being infected by the virus than the control (untreated)
macrophages, regardless of whether the person who donated the blood cells was
depressed. "These findings lend support to the evidence suggesting that
serotonergic and glucocorticoid systems are mediators in the relationship
between depression and immune function," the researchers concluded.
The study was funded by the National Institute of Mental Health.
• Patients with bipolar II depression who have incomplete response to
lamotrigine did not benefit from the addition of bupropion, according to a
double-blind, placebo-controlled study presented by Scott Aaronson, M.D.,
director of the Clinical Research Programs and associate medical director of
the Retreat at Sheppard and Enoch Pratt Hospital, and colleagues. Thirty adult
bipolar II patients with Montgomery-Åsberg Depression Rating Scale
(MADRS) scores above 17 and Young Mania Rating Scale scores under 14 first
underwent eight weeks of open-label treatment with lamotrigine alone. Among
the 26 patients who completed the monotherapy phase, 20 did not reach a 50
percent improvement in their MADRS scores and were randomized to receive, in
addition to lamotrigine, either bupropion 150 mg to 300 mg daily or placebo
for 16 weeks.
Between the nine patients who took bupropion and 11 who received placebo,
there was no difference in the scores on the depression and mania scales. In
other words, bupropion did not alleviate symptoms or induce mania in these
The study was funded by GlaxoSmith-Kline, which makes bupropion.
• SSRIs are inadequately prescribed for Medicaid-enrolled patients
with newly diagnosed obsessive-compulsive disorder (OCD), a retrospective
study by Cheryl Hankin, Ph.D., and colleagues demonstrates. Between 1997 and
2006, 1,346 adults in the Florida Medicaid database received a new diagnosis
of OCD (that is, no OCD diagnosis in the previous two years), among whom 73.3
percent received the recommended SSRIs as first-line drug therapy consistent
with APA's clinical practice guideline for OCD treatment. Among these
patients, only 21.8 percent had an adequate course of pharmacotherapy for at
least 12 consecutive weeks at the target dose recommended by the
The study was funded by Jazz Pharmaceuticals Inc.
• An analysis of data from three randomized, double-blind, controlled
trials has found that iloperidone, an investigational antipsychotic drug being
developed by Vanda Pharmaceuticals, is not less effective than haloperidol in
the efficacy of long-term treatment of schizophrenia or schizoaffective
disorder. Nearly 500 patients received either iloperidone or haloperidol
(n=359 and 114, respectively) in a double-blinded fashion for 46 weeks after
they had completed a six-week, randomized, double-blind, acute treatment trial
of the two drugs and had responded to the treatment. The relapse rate was 43.5
percent in the iloperidone group and 41.2 percent in the haloperidol groups
during the 46-week, long-term phase; the mean time to relapse was 89.8 days
and 101.8 days, respectively. Statistical noninferiorit y analyses confirmed
that iloperidone was not significantly different from haloperidol in efficacy.
The discontinuation rate during the long-term trials was the same in both
groups at 36.4 percent.
In nine phase 2 and phase 3 clinical trials, pooled data indicated that
patients taking iloperidone had similar degrees of weight gain to patients on
risperidone and haloperidol. The mean change from baseline in
iloperidone-treated patients was +5.4 mg/dL in blood glucose level, -3.9 mg/dL
in total cholesterol level, -17.7 mg/dL in triglyceride level, and -1.8 ng/mL
in prolactin levels. Overall, 3,210 subjects had received iloperidone for a
mean duration of 230 days in these studies.
The trials were funded by Vanda Pharmaceuticals.
• A prospective, observational study of clozapine orally disintegrat
ing tablets (ODTs) indicated that this formulation of clozapine may have
favorable effects on salivation and weight in patients with schizophrenia who
have failed other atypical antipsychotic drugs or who have been taking regular
clozapine tablets. The preliminary results of this ongoing study were
collected from 261 patients at baseline, among whom 174 took clozapine ODT for
12 weeks. The mean weight at week 12 was not statistically significantly
different from baseline. The degree of salivation, assessed on a scale of 0 to
4, had a mean rating of 1.6 at baseline and 0.9 at week 12, and the decreasing
trend was statistically significant.
The study was funded by the maker of clozapine ODT, Azur Pharma.
• The efficacy of asenapine, an antipsychotic drug being developed by
Organon, now a subsidiary of Schering-Plough Corp., was found to be comparable
to that of olanzapine in a one-year, randomized, double-blind study as
maintenance treatment for patients with bipolar mania. After nine weeks of
acute treatment, the mean score change on the YMRS from baseline was -24.4 in
the asenapine group and -23.9 in the olanzapine group. After an additional 40
weeks, the response rates (50 percent reduction in YMRS score) were 93 percent
in the asenapine group and 95 percent in the olanzapine group.
Treatment-related adverse events occurred in 65.7 percent of patients in
the asenapine group and 61.7 percent in the olanzapine group. Weight gain,
metabolic syndrome, and hyperprolactinemia were more commonly seen in the
olanzapine group, while extrapyramidal symptoms were more frequent in the
Among the 504 patients who entered the initial nine-week study, 229 were
randomized to the olanzapine group. Two hundred and eighteen patients entered
the 40-week extension phase, including 68 who took olanzapine and 65 who took
asenapine. Among the 133 (61 percent) patients who completed the extension
phase, the two groups had similar dropout rates.
The study was funded by Organon and Pfizer.
• ABT-089, an investigational drug being developed by Abbott
Laboratories, has shown efficacy in treating adults with
attention-deficit/hyperactivity disorder (ADHD). ABT-089 is a neuronal
nicotinic receptor partial agonist.
In a phase 2, double-blind, crossover clinical trial, 221 adults with ADHD
were randomly assigned to receive both ABT-089 and placebo for four weeks each
with a two-week washout period in between. The active drug, at doses of 40 mg
four times daily and twice daily, was more effective than placebo in reducing
symptoms as measured by the investigator-rated Conners' Adult ADHD Rating
Scale. The drug was generally well tolerated, and the most common adverse
events included headache, insomnia, and upper respiratory infection.
In two other studies in healthy adults, a single dose of ABT-089 up to 60
mg (n=72) or multiple doses up to 40 mg twice daily for seven days (n=43) did
not result in elevations of systolic and diastolic blood pressure or heart
rate. In a study of adult ADHD patients, the ABT-089 and placebo groups did
not differ significantly in blood pressure and heart rate changes from
The study was funded by Abbott Laboratories. ▪