Amir Kalali

Publications (7)33.1 Total impact

• Article: A failed 6-week,randomized, double-blind, placebo-controlled study of once-daily extended release quetiapine fumarate in patients with acute schizophrenia: lessons learned.

  Andrew J Cutler, Tram Tran-Johnson, Amir Kalali, Mikael Aström, Martin Brecher, Didier Meulien
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  ABSTRACT: To demonstrate the efficacy of once-daily extended release quetiapine fumarate (quetiapine XR) versus placebo in adults with acute exacerbation of schizophrenia. A 6-week, double-blind, randomized, placebo-controlled study. In- or out-patients with a DSM-IV diagnosis of schizophrenia were randomized to fixed-dose quetiapine XR 400, 600, or 800 mg/day, quetiapine immediate release (IR) 800 mg/day, or placebo. Primary endpoint was change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 6. Other efficacy assessments included Clinical Global Impressions (CGI) of Severity (CGI-S) and of Improvement (CGI-I) ratings. Safety assessments included adverse event (AE) reporting and laboratory measures. 565 patients were randomized; 333 (58.9%) completed the study. Greater numeric improvements in PANSS total score were seen for quetiapine XR (all doses) and quetiapine IR versus placebo at Week 6; the differences were not statistically significant. Secondary efficacy endpoint results were similar. There was not a high placebo response in this study, but rather an attenuation of drug effect. In general, quetiapine XR was well tolerated over 6-weeks' treatment; there were no unexpected AEs. The efficacy of quetiapine XR (400, 600, and 800 mg/day) was not established at Week 6. Quetiapine IR, an agent with established efficacy in schizophrenia, also did not separate from placebo at endpoint. Therefore, this is considered a failed study and possible reasons for this are discussed. Quetiapine XR was generally well tolerated and its safety profile was consistent with the known profile of quetiapine.
  Psychopharmacology bulletin 01/2010; 43(4):37-69. · 1.35 Impact Factor
• Article: Treatment of depression: an update on antidepressant monotherapy and combination therapy.

  Susan Lenderts, Amir Kalali
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  ABSTRACT: We analyzed the trends in product regimens used to treat depression to investigate whether there has been a shift in treatment patterns following the May 2008 launch of desvenalfaxine in the United States and the approval of an atypical antipsychotic as add-on therapy to antidepressants. Our analysis suggests that antidepressant monotherapy continues to be the most widely used drug treatment approach, accounting for 84 percent of depression treatment regimens. Antidepressant monotherapy is more prevalent among primary care physician-prescribed treatment regimens (92%) than psychiatry-prescribed regimens (73%). Combination treatment regimens have become increasingly more common as physician perception of disease severity increases, with antidepressant combination therapy accounting for eight percent, 17 percent, and 27 percent of treatment regimens for mild, moderate, and severe depression, respectively. The most commonly used agents in addition to an antidepressant in combination treatment regimens include another antidepressant (40% of combination regimens), an anxiety agent (40%), and/or atypical antipsychotics (18%). A trend analysis suggests that combination regimens that include an antidepressant plus an atypical antipsychotic, anxiety agent, or a prescription sleep aid comprise a greater share of combination regimens in 12 months ending May 2009 than they did in 12 months ending June 2008.
  Psychiatry 08/2009; 6(8):15-7.
• Article: Use of antipsychotics in children.

  Elisa Cascade, Amir Kalali, Robert Findling
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  ABSTRACT: Over the 2004 through 2008 period, total second-generation antipsychotic prescriptions grew 33 percent from 6.9 million to 9.2 million; second-generation antipsychotic prescriptions for patients under age 18 also increased, but at a slightly slower rate: 24-percent increase from 1.0 million to 1.2 million prescriptions. One-third of patients under age 18 who are prescribed second-generation antipsychotics use them for the treatment of affective psychoses, primarily bipolar disorder (34%). Other common uses for second-generation antipsychotics include hyperkinetic syndrome (12%), pervasive developmental disorders (10%), emotional disorders of children/adolescents (10%), and conduct disturbance (7%). A discussion of the data is provided.
  Psychiatry 07/2009; 6(6):21-3.
• Article: The GRID-HAMD: standardization of the Hamilton Depression Rating Scale.

  Janet B W Williams, Kenneth A Kobak, Per Bech, Nina Engelhardt, Ken Evans, Joshua Lipsitz, Jason Olin, Jay Pearson, Amir Kalali
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  ABSTRACT: This report describes the GRID-Hamilton Depression Rating Scale (GRID-HAMD), an improved version of the Hamilton Depression Rating Scale that was developed through a broad-based international consensus process. The GRID-HAMD separates the frequency of the symptom from its intensity for most items, refines several problematic anchors, and integrates both a structured interview guide and consensus-derived conventions for all items. Usability was established in a small three-site sample of convenience, evaluating 29 outpatients, with most evaluators finding the scale easy to use. Test-retest (4-week) and interrater reliability were established in 34 adult outpatients with major depressive disorder, as part of an ongoing clinical trial. In a separate study, interrater reliability was found to be superior to the Guy version of the HAMD, and as good as the Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D), across 30 interview pairs. Finally, using the SIGH-D as the criterion standard, the GRID-HAMD demonstrated high concurrent validity. Overall, these data suggest that the GRID-HAMD is an improvement over the original Guy version as well as the SIGH-D in its incorporation of innovative features and preservation of high reliability and validity.
  International Clinical Psychopharmacology 06/2008; 23(3):120-9. · 2.92 Impact Factor
• Source

  Available from: Charles B Nemeroff

  Article: Impact of publicity concerning pediatric suicidality data on physician practice patterns in the United States.

  Charles B Nemeroff, Amir Kalali, Martin B Keller, Dennis S Charney, Susan E Lenderts, Elisa F Cascade, Hugo Stephenson, Alan F Schatzberg
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  ABSTRACT: IMS Health Inc data presented by the Food and Drug Administration (FDA) on September 13 and 14, 2004, at a joint meeting of the Center for Drug Evaluation and Research's Psychopharmacologic Drugs Advisory Committee and the FDA's Pediatric Advisory Committee suggested that the number of children and teenagers who were prescribed antidepressants continued to increase in 2004, despite widespread publicity surrounding 2 FDA advisories regarding the potential for pediatric suicidality with selective serotonin reuptake inhibitor use. These results are contradictory to findings from the Medco Health Solutions, Inc, March 2004 analysis of pharmacy benefit claims and a separate subsequent analysis conducted by NDC Health using dispensing data from March 31, 2004, through June 30, 2005. To investigate the contradictory findings and provide additional analyses on the prescribing trends of antidepressants across age groups and physician specialties in the United States. Retail pharmacy prescription data and physician audit data were obtained from Verispan, a joint venture between Quintiles Transnational and McKesson. In addition to examining prescribing trends, a joinpoint regression analysis was conducted to identify the timing for significant changes in prescription use. The analyses suggest that the number of children and teenagers who were prescribed antidepressants has decreased significantly (P = .02) in the wake of widespread publicity surrounding the FDA public health advisories. Another impact of the advisories seems to be a shift in care from "generalists" to psychiatric specialists when it comes to prescribing antidepressants to patients younger than 18 years. Finally, the analyses highlight a slight shift in prescribing toward the non-selective serotonin reuptake inhibitor bupropion hydrochloride, even though it carries the same FDA "black box" warning as the selective serotonin reuptake inhibitors. The effect on antidepressant prescribing volume observed in our analysis of the Verispan data parallels earlier findings reported by Medco Health Solutions, Inc, and NDC Health that the FDA actions have had a significant effect on the prescribing of antidepressants to children and adolescents. Together, these findings underline the importance of presenting a fair balance within the media due to the significant reach of this channel among prescribing physicians.
  Archives of General Psychiatry 04/2007; 64(4):466-72. · 12.02 Impact Factor
• Article: Extended-release carbamazepine capsules as monotherapy in bipolar disorder : pooled results from two randomised, double-blind, placebo-controlled trials.

  Richard H Weisler, Robert Hirschfeld, Andrew J Cutler, Thomas Gazda, Terence A Ketter, Paul E Keck, Alan Swann, Amir Kalali
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  ABSTRACT: Recently, two large, 3-week, randomised, double-blind, placebo-controlled trials using nearly identical protocols demonstrated that monotherapy with carbamazepine extended-release capsules (CBZ-ERC) was effective for the treatment of acute mania in patients with bipolar I disorder. By pooling data from these two trials, a more highly powered analysis of the efficacy and safety of CBZ-ERC in bipolar I disorder could be conducted. Efficacy was assessed with the Young Mania Rating Scale (YMRS), the Clinical Global Impression (CGI)-Severity (CGI-S) scale, the CGI-Improvement (CGI-I) scale and the Hamilton Depression Rating Scale (HDRS). A sub-analysis of the data based on manic versus mixed presentation was performed, as well as sub-analyses by age, sex and ethnicity. Of the 443 randomised patients in the pooled population, 240 completed the studies. Forty-two percent of CBZ-ERC-treated patients did not complete the studies, compared with 50% of placebo-treated patients (p=0.087). Ten percent of patients given CBZ-ERC withdrew because of lack of efficacy, compared with 22% of patients given placebo (p<0.001). At endpoint, CBZ-ERC compared with placebo was associated with significant improvements in mean YMRS total scores in patients experiencing both manic (p<0.0001) and mixed (p<0.01) episodes, using last-observation-carried-forward analyses. CGI-I and CGI-S scores also showed significant improvements from baseline for both manic and mixed patients at endpoint. In patients with mixed episodes, at endpoint there was a mean improvement in HDRS total score of 4.8 points with CBZ-ERC, compared with 2.3 points with placebo (p<0.05). Ninety percent of patients given CBZ-ERC experienced an adverse event, compared with 64% of those patients given placebo. Discontinuation because of adverse events occurred in 10.8% of patients taking CBZ-ERC, compared with 5.5% of patients taking placebo. These results confirm previous findings that CBZ-ERC is effective in the treatment of bipolar I disorder patients with either acute manic or mixed episodes. These data suggest that further randomised controlled studies are warranted to delineate the effect of CBZ-ERC on depressive symptoms in patients with bipolar disorder.
  CNS Drugs 02/2006; 20(3):219-31. · 4.80 Impact Factor
• Article: Improving clinical trials: American Society of Clinical Psychopharmacology recommendations.

  Donald F Klein, Michael E Thase, Jean Endicott, Lawrence Adler, Ira Glick, Amir Kalali, Steven Leventer, Jeffrey Mattes, Peter Ross, Alexander Bystritsky
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  ABSTRACT: The major purpose of this American Society of Clinical Psychopharmacology-sponsored meeting was to identify strategies for more efficiently detecting clinical drug effects, thus reducing the economic and scientific risks of investigating new chemical entities in psychiatric disorders. The meeting consisted of presentations and discussions by experts who repeatedly had difficulty pursuing scientific, public health--relevant goals. Many approaches to improving the detection of potentially beneficial agents were reviewed. In this article, we discuss technically feasible study improvements. The scope of inquiry included identifying means of shifting institutional and regulatory assumptions and processes, even to the point of seeking appropriate national incentives.
  Archives of General Psychiatry 04/2002; 59(3):272-8. · 12.02 Impact Factor