<?xml version="1.0" encoding="utf-8"?>
<recommendedContent xmlns="http://api.mspoke.com">
    <recommendedItem id="20100101_19_359"
                     title="Fish Oil May Prevent Psychotic Episodes (CME/CE)"
                     score="0.009"
                     href="http://www.medpagetoday.com/Psychiatry/Schizophrenia/tb/18242?impressionId=1265799847877"
                     
      &lt;p&gt;High-risk psychiatric patients were less likely to have psychotic episodes when they took daily doses of omega-3 (&amp;#969;-3) polyunsaturated fatty acids (PUFAs), according to results of a small, randomized clinical trial.&lt;/p&gt;
&lt;p&gt;Fewer than 5% of patients had psychotic episodes with &amp;#969;-3 PUFAs, versus more than 25% of patients given placebo (&lt;em&gt;P&lt;/em&gt;=0.007), investigators reported in the February &lt;em&gt;Archives of General Psychiatry&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;The &amp;#969;-3 PUFAs, derived from fish among other sources, also reduced positive, negative, and general symptoms and improved functioning compared with placebo, the researchers found.&lt;/p&gt;
&lt;p&gt;&quot;The present trial strongly suggests that &amp;#969;-3 PUFAs may offer a viable prevention and treatment strategy with minimal associated risk in young people at ultra-high risk of psychosis, which should be further explored,&quot; G. Paul Amminger, MD, of the Medical University of Vienna in Austria, and co-authors concluded.&lt;/p&gt;
&lt;p&gt;Early treatment of schizophrenia and other psychotic conditions may lead to better outcomes, the researchers noted. Subclinical psychotic symptoms may predict psychotic disorder, and the propensity for psychosis in a particular population may influence the prevalence and incidence of psychotic disorders.&lt;/p&gt;
&lt;p&gt;Intervention in at-risk populations, therefore, may lead to even better outcomes, they asserted.&lt;/p&gt;
&lt;p&gt;Dysfunctional fatty acid metabolism has been proposed as a contributing factor in psychotic conditions, and several clinical trials have demonstrated beneficial effects of &amp;#969;-3 PUFA supplementation in patients with schizophrenia. Some studies, however, yielded negative results.&lt;/p&gt;
&lt;p&gt;Data from the schizophrenia studies, evidence of neuroprotective properties, and an absence of clinically relevant adverse effects make &amp;#969;-3 PUFAs &quot;an ideal candidate for indicated prevention in young people at risk of psychosis, in whom the use of antipsychotic medication is controversial, the authors wrote.&lt;/p&gt;
&lt;p&gt;To evaluate potential benefits of &amp;#969;-3 PUFAs in subclinical psychosis, investigators enrolled patients ages 13 to 25 who met criteria for one of three operationally-defined, high-risk groups: attenuated positive psychotic symptoms, transient psychosis, and genetic risk plus a decrease in functioning.&lt;/p&gt;
&lt;p&gt;&quot;These criteria comprise a combination of trait and state factors that identify people whose risk of becoming psychotic may approach 40% within a 12-month period,&quot; the authors wrote.&lt;/p&gt;
&lt;p&gt;The study included 81 patients, who were randomized to 1.2 g/d &amp;#969;-3 PUFA or matching placebo for 12 weeks, plus 12-months of follow-up.&lt;/p&gt;
&lt;p&gt;The authors reported that 76 patients (38 in each group) completed the 12-week intervention phase and 67 completed the 12-month follow-up. The primary outcome was conversion to a psychotic episode, defined by the Positive and Negative Syndrome Scale (PANSS) and sustained for one week.&lt;/p&gt;
&lt;p&gt;At 12 months, two of 41 patients assigned to &amp;#969;-3 PUFA therapy (4.9%) converted to psychotic episodes, compared with 11 of 40 (27.5%) in the placebo group.&lt;/p&gt;
&lt;p&gt;The &amp;#969;-3 group also had significantly lower PANSS positive, negative, general, and total scores at 12 weeks, six months, and 12 months (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05 to &lt;em&gt;P&lt;/em&gt;=0.01). Patients in the &amp;#969;-3 group also had significantly better functioning (&lt;em&gt;P&lt;/em&gt;=0.002).&lt;/p&gt;
&lt;p&gt;Calculation of number needed to treat (NNT) showed that four at-risk patients would have to be treated to prevent one psychotic episode during one year, which the authors said is comparable to the NNT from trials of antipsychotic medications.&lt;/p&gt;
&lt;p&gt;The authors noted several limitations, including the relatively small size of the study and the fact that this was a highly selected population, so the results cannot be generalized.&lt;/p&gt;
&lt;p&gt;In addition, they pointed out that efficacy beyond the 12 month study period is unknown and it is possible that the transition to a first episode of psychosis may have been delayed rather than prevented.&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The study was supported by the Stanley Medical Research Institute.&lt;/p&gt;&lt;p&gt;The authors reported no relevant disclosures.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_356"
                     title="Exercise Builds Brain Volume in Schizophrenia (CME/CE)"
                     score="0.009"
                     href="http://www.medpagetoday.com/Psychiatry/Schizophrenia/tb/18236?impressionId=1265799847877"
                     
      &lt;p&gt;Three months of aerobic exercise significantly increased the volume of the hippocampus in patients with chronic schizophrenia, researchers said.&lt;/p&gt;
&lt;p&gt;The increase was accompanied by &quot;modest&quot; increases in short-term memory and markers of neuron production, according to Frank-Gerald Pajonk, MD, of Dr K. Fontheim&apos;s Hospital for Mental Health in Liebenburg, Germany, and colleagues.&lt;/p&gt;
&lt;p&gt;But it&apos;s too early to say whether incorporating aerobic exercise into treatment programs might reduce the disability associated with schizophrenia, the researchers said in the February&lt;em&gt; Archives of General Psychiatry&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Among schizophrenics, the hippocampus, which plays important roles in memory and spatial navigation, is known to be reduced in volume, Pajonk and colleagues noted.&lt;/p&gt;
&lt;p&gt;Unlike other forms of psychosis, they added in the journal, schizophrenia is characterized by persistent disability, perhaps because the production of new neurons is impaired.&lt;/p&gt;
&lt;p&gt;As well, they noted, in healthy humans it has been shown that exercise stimulates the production of new neurons.&lt;/p&gt;
&lt;p&gt;For those reasons, they speculated that aerobic exercise might increase the volume of the hippocampus in people with chronic schizophrenia, perhaps leading to clinical benefits.&lt;/p&gt;
&lt;p&gt;To test the idea, they enrolled 24 schizophrenia patients and eight healthy controls.&lt;/p&gt;
&lt;p&gt;Thirteen of the patients, selected randomly, were assigned to a three-month program of aerobic exercise  --  cycling three times a week for 30 minutes. The controls also took part in the cycling program.&lt;/p&gt;
&lt;p&gt;The remaining patients were assigned to play table soccer, again for 30 minutes three times a week.&lt;/p&gt;
&lt;p&gt;The primary endpoint was the change in hippocampal volume, assessed by magnetic resonance imaging, but the researchers also looked at changes in schizophrenia symptom scores, memory, and the ratio of N-acetylaspartate to creatine in the hippocampus. The latter is a regarded as a marker of neuron production.&lt;/p&gt;
&lt;p&gt;They found: &lt;ul&gt; &lt;li&gt;Compared to baseline, hippocampal volume increased 12% in the exercise group and 16% in the controls, changes that were significant at &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001.&lt;/li&gt; &lt;li&gt;On the other hand, there was a nonsignificant 1% drop in volume among patients who did not take exercise.&lt;/li&gt; &lt;li&gt;The changes in hippocampal volume in the exercise group were significantly correlated (at r=0.71 and &lt;em&gt;P&lt;/em&gt;=0.003) with better aerobic fitness, as measured by change in maximum oxygen consumption.&lt;/li&gt; &lt;li&gt;Among patients in the exercise group, change in hippocampal volume was associated with a 35% increase in the N-acetylaspartate to creatine ratio, which was significant (in a post-hoc analysis) at &lt;em&gt;P&lt;/em&gt;=0.04. There was no significant change in the healthy controls.&lt;/li&gt; &lt;li&gt;And short-term memory improvements among the patients were correlated (at r=0.51 and &lt;em&gt;P&lt;/em&gt;&amp;lt;0.05) with changes in hippocampal volume.&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;The change in hippocampal volume was the &quot;most robust&quot; of the findings, Pajonk and colleagues said, and is roughly comparable with what is seen in other subcortical structures when schizophrenia patients switch from typical to atypical medications.&lt;/p&gt;
&lt;p&gt;The study was limited by its small size, they said, and the volunteers were selected for their willingness to take part in three months of an exercise program.&lt;/p&gt;
&lt;p&gt;As well, patients had to have chronic disease and be on stable medication programs, they said.&lt;/p&gt;
&lt;p&gt;They also noted that while the main finding was robust, the statistical significance of the secondary results would not have survived a correction for multiple testing.&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The researchers did not report any industrial support for the study. Pajonk reported financial links with AstraZeneca, Eli Lilly, Janssen, Novartis, Wyeth, Bristol-Myers Squibb, Pfizer, Sanofi-Synth&amp;#233;labo, and Merz.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20090101_19_1056"
                     title="FDA Review Questions Cardiac, Suicide Risks for Investigational Antipsychotic"
                     score="-0.005"
                     href="http://www.medpagetoday.com/Psychiatry/Schizophrenia/tb/13619?impressionId=1265799847877"
                     
       WASHINGTON, April 6 -- Investigational antipsychotic drug sertindole (Serdolect) is effective at treating schizophrenia, but it may lead to sudden cardiac death, according to an FDA review. 
              &lt;p&gt; 
              &lt;p&gt;The agency released its review in advance of Tuesday&apos;s meeting of the Psychopharmacologic Drugs Advisory Committee, which will decide if the drug&apos;s cardiovascular risk is an obstacle to FDA approval. 
              &lt;p&gt; 
              &lt;p&gt;The advisory panel will also consider the sponsor&apos;s suicide prevention claim, and whether to recommend to the FDA that the drug is safe and effective. The vote will effectively amount to a recommendation of approval or denial.
              &lt;p&gt; 
              &lt;p&gt;Sertindole is already used in other countries to treat schizophrenia. 
              &lt;p&gt; 
              &lt;p&gt;According to the FDA review, led by psychiatrist Phillip Kronstein, M.D., sertindole is effective in treating schizophrenia, but concerns remain about the drug&apos;s potential to prolong the heart&apos;s QT interval, which can lead to sudden cardiac death. That same cardiac risk has been seen in other antipsychotic drugs similar to sertindole. 
              &lt;p&gt; 
              &lt;p&gt;Sertindole is a so-called atypical antipsychotic drug, Its specific mechanism appears to be to inhibit spontaneously active dopamine neurons in the mesolimbic ventral tegmental area without affecting dopamine neurons in the substantial nigra compacta. 
              &lt;p&gt; 
              &lt;p&gt;A recent study found that atypical antipsychotics carry a risk of sudden cardiac death similar to that associated with older schizophrenia drugs.  (See: &lt;a href=&quot;http://www.medpagetoday.com/Psychiatry/Schizophrenia/12453&quot; target=&quot;blank&quot;&gt;Risk of Sudden Death No Less Likely with Atypical Antipsychotics&lt;/a&gt;) 
              &lt;p&gt; 
              &lt;p&gt;Sertindole has been approved in the U.K. since 1996. But use of the drug was temporarily suspended after an online database indicated that sertindole might cause more deaths than risperidone (Risperdal). The drug&apos;s manufacturer, Lundbeck, agreed to perform a large randomized parallel-group study comparing all-cause death, cardiac death, and suicide for sertindole versus risperidone.
              &lt;p&gt; 
              &lt;p&gt;Based on results from that nearly 10,000-patient study, which did not show an increase in all-cause mortality with sertindole, the restrictions on the drug were lifted. 
              &lt;p&gt; 
              &lt;p&gt;But in Lundbeck&apos;s analyses to prepare for U.S. approval, the FDA reviewers didn&apos;t think the comparable all-cause mortality data was exactly a home run for sertindole, &quot;given the relatively higher mortality in this population from multiple causes,&quot; Dr. Kronstein said. 
              &lt;p&gt; 
              &lt;p&gt;More relevant are the cardiac deaths, in light of sertindole&apos;s connection to heart problems, he said. The FDA review found that patients taking sertindole had a significantly higher risk of cardiac death compared with those taking risperidone (&lt;em&gt;P&lt;/em&gt;=0.002). 
              &lt;p&gt; 
              &lt;p&gt;Thirteen patients died suddenly from cardiac causes in the sertindole group, compared with three who were taking risperidone. 
              &lt;p&gt; 
              &lt;p&gt;&quot;This is a significant and concerning result, indicating that sertindole-treated patients had an approximately five times higher risk of sudden cardiac death,&quot; according to the review.
              &lt;p&gt; 
              &lt;p&gt;The other major question for the committee is whether Lundbeck can justifiably claim that sertindole prevents suicidality better than other antipsychotic drugs.
              &lt;p&gt; 
              &lt;p&gt;Lundbeck has proposed to include such a claim in the product&apos;s label. In the company&apos;s trials, there were 14 suicide deaths among sertindole patients and 21 in the risperidone group.
              &lt;p&gt; 
              &lt;p&gt;But the FDA&apos;s staff review disagreed with the way Lundbeck examined suicide risk, and requested that the company analyze all suicide attempts instead of only those that succeeded.
              &lt;p&gt; 
              &lt;p&gt;According to the briefing documents for the meeting, this second analysis found that 46 patients attempted suicide during treatment and up to 30 days after in the sertindole group, compared with 62 in the risperidone group, with the difference failing to reach statistical significance.
              &lt;p&gt; 
              &lt;p&gt;The panel is to vote on whether the data show that sertindole reduces suicidality in schizophrenic patients.
              &lt;p&gt; 
              &lt;p&gt;As for the drug&apos;s efficacy in schizophrenia symptoms, two clinical trials have adequately proved the short-term antipsychotic efficacy of between 12 mg and 20 mg daily doses of sertindole, according to the FDA&apos;s Dr. Kronstein. 
              &lt;p&gt; 
              &lt;p&gt;There are no adequate and well-controlled data to address long-term efficacy, he said. 
              &lt;p&gt; 
              &lt;p&gt;The FDA does not have to follow the advice of the panels, but it usually does.
    </recommendedItem>
    <recommendedItem id="20090101_19_1082"
                     title="FDA Panel Recommends Limited Use of Investigational Antipsychotic"
                     score="-0.005"
                     href="http://www.medpagetoday.com/Psychiatry/Schizophrenia/tb/13646?impressionId=1265799847877"
                     
       SILVER SPRING, Md., April 7 -- An FDA advisory panel voted to recommend FDA approval for sertindole (Serdolect) to treat schizophrenia, but only for a subgroup of patients that the agency would have to define.
              &lt;p&gt; 
              &lt;p&gt;The lukewarm backing came in part because of studies showing that patients taking sertindole were more than four times as likely to die suddenly, compared with another atypical antipsychotic, risperidone (Risperdal). 
              &lt;p&gt; 
              &lt;p&gt;In fact, the Psychopharmacologic Drugs Advisory Committee voted 12 to 1 that the drug is not &quot;acceptably safe&quot; for the general schizophrenic population.  
              &lt;p&gt; 
              &lt;p&gt;But the panel unanimously agreed the drug is effective and then voted 8 to 2, with three members abstaining, that some patients might benefit from having sertindole as an option. 
              &lt;p&gt; 
              &lt;p&gt;The committee did not clearly identify those patients, however, leaving it to the FDA to decide which patients, if any, should receive the drug, manufactured by Lundbeck and currently marketed in other countries.
              &lt;p&gt; 
              &lt;p&gt;One panelist suggested that sertindole only be prescribed for schizophrenics who have not responded to other drugs, and another suggested performing cardiac tests to give some hint of whether a patient might be at increased risk for heart problems. 
              &lt;p&gt; 
              &lt;p&gt;&quot;I would hope this is a treatment of last resort,&quot; said Gail Griffith, M.S., the consumer representative on the panel.
              &lt;p&gt; 
              &lt;p&gt;Sertindole prolongs the heart&apos;s QT interval, which may lead to major cardiac problems, including sudden death. In the sponsor&apos;s trial, there were 13 sudden cardiac deaths among patients taking sertindole and three among patients taking risperidone (&lt;em&gt;P&lt;/em&gt;=0.002).
              &lt;p&gt; 
              &lt;p&gt;&quot;The cardiovascular risk is real, but I think that is counterbalanced by the need for other treatment,&quot; said Sheryl Kelsey, Ph.D., professor of epidemiology at University of Pittsburgh. Kelsey is a temporary member of the Cardiovascular and Renal Drugs Advisory Committee, which had three of its members voting on Tuesday&apos;s panel. 
              &lt;p&gt; 
              &lt;p&gt;Sudden cardiac death has been seen in other antipsychotic drugs similar to sertindole.
              &lt;p&gt; 
              &lt;p&gt;(See: &lt;a href=&quot;http://www.medpagetoday.com/Psychiatry/Schizophrenia/12453&quot; taraget=&quot;blank&quot;&gt;Risk of Sudden Death No Less Likely with Atypical Antipsychotics&lt;/a&gt;) 
              &lt;p&gt; 
              &lt;p&gt;The panel also swatted away Lundbeck&apos;s proposed claim that sertindole could help prevent suicide among schizophrenic patients. About half of all schizophrenic patients attempt suicide, according to the drugmaker. 
              &lt;p&gt; 
              &lt;p&gt;But the committee voted 12 to 1 that patients taking sertindole are no less likely to contemplate, attempt, or succeed in taking their lives, compared with those taking antischizophrenia drug risperidone.  
              &lt;p&gt; 
              &lt;p&gt;An FDA analysis found that 36 sertindole-treated patients attempted suicide, compared with 54 in the risperidone group, but the difference failed to reach statistical significance.
              &lt;p&gt; 
              &lt;p&gt;The efficacy data on which the panel based its vote came from the sponsor&apos;s trials involving more than 10,000 patients.
              &lt;p&gt; 
              &lt;p&gt;These studies adequately proved the short-term antipsychotic efficacy of 12- to 20-mg daily doses of sertindole, according to the lead FDA staff reviewer, psychiatrist Phillip Kronstein, M.D.
              &lt;p&gt; 
              &lt;p&gt;The FDA does not have to follow the advice of its advisory panels, but it usually does.  
              &lt;p&gt; 
              &lt;p&gt;(See: &lt;a href=&quot;http://www.medpagetoday.com/Psychiatry/Schizophrenia/13619&quot; target=&quot;blank&quot;&gt;FDA Review Questions Cardiac, Suicide Risks for Investigational Antipsychotic&lt;/a&gt;)
    </recommendedItem>
    <recommendedItem id="20090101_19_1605"
                     title="APA: Novel Antipsychotic Promising for Schizophrenia"
                     score="-0.005"
                     href="http://www.medpagetoday.com/MeetingCoverage/APA/tb/14344?impressionId=1265799847877"
                     
       SAN FRANCISCO, May 22 -- The experimental psychotropic agent lurasidone appeared effective in acute schizophrenia, according to the first phase III data on the drug.
              &lt;p&gt; 
              &lt;p&gt;The intermediate 80-mg dose of the novel compound significantly improved total scores on the Positive and Negative Syndrome Scale (PANSS) by about eight points more than placebo over six weeks of treatment in the randomized controlled trial.
              &lt;p&gt; 
              &lt;p&gt;However, the 40- and 120-mg per day doses did not appear better than placebo for either the primary or secondary endpoints in the trial, Antony Loebel, Ph.D., of Dainippon Sumitomo Pharma America in Fort Lee, N.J., and colleagues found.
              &lt;p&gt; 
              &lt;p&gt;All doses appeared to be well tolerated with little impact on weight and lipids, they reported here at the American Psychiatric Association meeting.
              &lt;p&gt; 
              &lt;p&gt;Lurasidone is part of the pipeline of psychotropics that have been called the &quot;me-too&quot; medications. It has high affinity for dopamine (D&lt;sub&gt;2&lt;/sub&gt;) and serotonin 5-HT2A receptors.
              &lt;p&gt; 
              &lt;p&gt;But Dr. Loebel highlighted its uniqueness among psychotropics in affinity for serotonin receptors implicated in the enhancement of cognition, mood, and negative symptoms (5-HT7, 5-HT1A and alpha-2c).
              &lt;p&gt; 
              &lt;p&gt;He also noted that the compound&apos;s low attraction to noradrenaline alpha-1, histamine H&lt;sub&gt;1&lt;/sub&gt;, and cholinergic M&lt;sub&gt;1&lt;/sub&gt; receptors may minimize weight gain and other problems seen with psychotropics currently on the market.
              &lt;p&gt; 
              &lt;p&gt;Dr. Loebel&apos;s group reported safety and efficacy findings from the phase III 
              &lt;p&gt;PEARL 1 (Program to Evaluate the Antipsychotic Response to Lurasidone) trial along with three phase II studies (006, 049, and 196).
              &lt;p&gt; 
              &lt;p&gt;All four studies randomized patients meeting diagnostic criteria for an acute exacerbation of schizophrenia to double-blind treatment over six weeks with placebo or a fixed daily dose of lurasidone (40, 80, or 120 mg). 
              &lt;p&gt; 
              &lt;p&gt;Study 049 was excluded from the efficacy analysis, because the researchers considered it a &quot;failed study&quot; because neither the active comparator haloperidol (Haldol) nor lurasidone separated from placebo on any measure.
              &lt;p&gt; 
              &lt;p&gt;All three lurasidone doses were significantly better than placebo in the pooled analysis across studies for the primary outcome of change in positive and negative symptoms measured by the PANSS total score and the key secondary endpoint of change in the Clinical Global Impression-Severity scale.
              &lt;p&gt; 
              &lt;p&gt;In the PEARL 1 study, the 80 mg lurasidone dose produced significant PANSS improvements compared with placebo at every point from two weeks through to the end of the trial (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05).
              &lt;p&gt; 
              &lt;p&gt;Although the 120 mg dose also separated from placebo at the week two and week three assessments, neither it nor the 40 mg dose were any better than placebo on PANSS at the end of the trial.
              &lt;p&gt; 
              &lt;p&gt;For the positive symptom subscores, both higher doses were significantly better than placebo from day four through the end of the trial (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05 to &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001).
              &lt;p&gt; 
              &lt;p&gt;CGI-Severity scores showed the same pattern of no significance for the 40 mg dose, significance only at weeks four and five for the 120 mg dose, and consistent improvements with the 80 mg dose.
              &lt;p&gt; 
              &lt;p&gt;The researchers did not calculate the number needed to treat.
              &lt;p&gt; 
              &lt;p&gt;In both the pooled phase II trials and the PEARL 1 trial, lurasidone did not increase lipids. 
              &lt;p&gt; 
              &lt;p&gt;Weight gain on six weeks of lurasidone compared with placebo was:
              &lt;p&gt; 
              &lt;ul type=&quot;disc&quot;&gt;
                &lt;li&gt;An average of 0.46 kg (1.01 lb) for lurasidone and 0.16 kg (0.35 lb) for placebo in the pooled phase II studies
                &lt;li&gt;An average of 0.92 kg (2.02 lb) for lurasidone and 0.30 kg (0.66 lb) for placebo in the PEARL 1 trial
                &lt;li&gt;Just as likely to be more than 7% of baseline body weight in the pooled phase II studies (5.2% versus 5.5%)
                &lt;li&gt;More likely to be greater than 7% of baseline body weight in the PEARL 1 study (8.2% to 3.2%)
              &lt;/ul&gt;
              &lt;p&gt; 
              &lt;p&gt;Treatment-emergent adverse events included sedation (11.2% to 12.8% across doses versus 6.2% placebo), nausea (6.5% to 12.8% versus 6.5%), somnolence 8.7% to 13.3% versus 4.7%), and akathisia or restless movement disorder (11.2% to 21.4% versus 4.1%).
              &lt;p&gt; 
              &lt;p&gt;Although only the 80 mg dose appeared effective in the phase III data, Dr. Loebel said his company is moving forward with the whole dose range in further studies. 
              &lt;p&gt; 
              &lt;p&gt;The company has said it plans to apply for FDA approval of lurasidone in 2010.
              &lt;p&gt; 
              &lt;p&gt;Other ongoing phase III trials with the investigational agent include active comparator arms, but long-term efficacy and tolerability need to be determined as well, Dr. Loebel said.
              &lt;p&gt; 
              &lt;p&gt;&lt;table cellspacing=&quot;0&quot; hspace=&quot;1&quot; style=&quot;border-style:solid; border-width:1px; border-color:#8dabbc; font-family:arial; font-size:12px; background-color:#DBE9F2; padding:5px 5px 5px 5px;&quot;&gt;
&lt;tr&gt;&lt;td&gt; The study was conducted by Dainippon Sumitomo Pharma America, which is developing the drug. Dr. Loebel and all co-authors reported being employed by the company.&lt;/td&gt;&lt;/tr&gt;&lt;/table&gt;
    </recommendedItem>
</recommendedContent>