Severity of depression and response to antidepressants and placebo: an analysis of the Food and Drug Administration databaseArif Khan
Northwest Clinical Research Center, Bellevue, Washington, USA
J Clin Psychopharmacol 22:40-5. 2002
..Early discontinuation was more frequent among patients whose mean initial HAM-D scores were higher. These data may help inform the design of future antidepressant clinical trials...
Suicide risk in patients with anxiety disorders: a meta-analysis of the FDA databaseArif Khan
Northwest Clinical Research Center, 1900 116th Avenue NE 112, Bellevue, WA 98004, USA
J Affect Disord 68:183-90. 2002
..Previous reports of suicide risk in patients with anxiety disorders have been inconsistent...
Psychiatric diagnosis and clinical trial completion rates: analysis of the FDA SBA reportsArif Khan
Northwest Clinical Research Center, Bellevue, WA 98004, USA
Neuropsychopharmacology 32:2422-30. 2007
..These findings may help in the design of future psychopharmacology clinical trials...
Symptom reduction and suicide risk in patients treated with placebo in antidepressant clinical trials: an analysis of the Food and Drug Administration databaseA Khan
Northwest Clinical Research Center, Bellevue, Wash, USA
Arch Gen Psychiatry 57:311-7. 2000
..7% with investigational drugs (n = 4,510), 41.7% with active comparators (n = 1,416), and 30.9% with placebo (n = 2,805). These data may help inform discussions about the use of placebo in antidepressant clinical trials...
Symptom reduction and suicide risk in patients treated with placebo in antidepressant clinical trials: a replication analysis of the Food and Drug Administration DatabaseA Khan
The Northwest Clinical Research Center, Bellevue, WA, USA
Int J Neuropsychopharmacol 4:113-8. 2001
..Symptom reduction was 47.9% with investigational drugs (n = 1172), 47.5% with active comparators (n = 161), and 35.5% with placebo (n = 606). These data may inform discussions about the use of placebo in antidepressant clinical trials...
Symptom reduction and suicide risk among patients treated with placebo in antipsychotic clinical trials: an analysis of the food and drug administration databaseA Khan
Northwest Clinical Research Center, Bellevue, Wash, USA
Am J Psychiatry 158:1449-54. 2001
..This study assesses symptoms and risks of suicide and suicide attempts in psychotic patients assigned to receive placebo in clinical trials...
Relationship between depression severity entry criteria and antidepressant clinical trial outcomesArif Khan
Northwest Clinical Research Center, Bellevue, Washington 98004, USA
Biol Psychiatry 62:65-71. 2007
..We assessed whether increasing the minimum prerandomization Hamilton Depression Rating Scale (HAM-D) score to enrich the severity of the depressed sample affects antidepressant trial outcome...
Suicide rates in clinical trials of SSRIs, other antidepressants, and placebo: analysis of FDA reportsArif Khan
Northwest Clinical Research Center, Bellevue, Washington, USA
Am J Psychiatry 160:790-2. 2003
..The authors analyzed reports from randomized controlled trials to compare suicide rates among depressed patients assigned to an SSRI, other antidepressants, or placebo...
Suicide risk analysis among patients assigned to psychotropics and placeboArif Khan
Northwest Clinical Research Center, Bellevue, WA 98004, USA
Psychopharmacol Bull 39:6-14. 2006
..These findings suggest that the high suicide risk among clinical trial participants is not significantly affected by psychotropics...
Suicide risk and symptom reduction in patients assigned to placebo in duloxetine and escitalopram clinical trials: analysis of the FDA summary basis of approval reportsArif Khan
Northwest Clinical Research Center, Bellevue, WA, USA
Ann Clin Psychiatry 19:31-6. 2007
..We assessed suicide and suicide attempt risk as well as symptom reduction among 3,282 depressed patients participating in duloxetine and escitalopram clinical trials assigned to either an antidepressant or placebo...
BMI, sex, and antidepressant responseArif Khan
Northwest Clinical Research Center, Bellevue, WA, USA
J Affect Disord 99:101-6. 2007
..However, to date no studies have measured the impact of body mass index (BMI) on men's and women's response to selective serotonin re-uptake inhibitors or placebo...
Sex differences in antidepressant response in recent antidepressant clinical trialsArif Khan
Northwest Clinical Research Center, 1900 116th Avenue NE 112, Bellevue, WA 98004, USA
J Clin Psychopharmacol 25:318-24. 2005
..These findings also raise the possibility that antidepressants may work somewhat differently in men and women...
Placebo response and antidepressant clinical trial outcomeArif Khan
Northwest Clinical Research Center, 1900 116th Avenue NE #112, Bellevue, Washington 98004, USA
J Nerv Ment Dis 191:211-8. 2003
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Antidepressant-placebo differences in 16 clinical trials over 10 years at a single site: role of baseline severityArif Khan
Northwest Clinical Research Center, 1951 152nd Place NE Suite 200, Bellevue, WA 98007, USA
Psychopharmacology (Berl) 214:961-5. 2011
..The current study was designed to examine antidepressant-placebo difference scores and baseline severity of depression over a 10-year period in a sample of depressed patients enrolled at a single clinical trial site...
Severity of depressive symptoms and response to antidepressants and placebo in antidepressant trialsArif Khan
Northwest Clinical Research Center, Bellevue, MA, USA
J Psychiatr Res 39:145-50. 2005
..These findings may help in the design of future antidepressant clinical trials...
Are placebo controls necessary to test new antidepressants and anxiolytics?Arif Khan
Northwest Clinical Research Center, Bellevue, WA 98004, USA
Int J Neuropsychopharmacol 5:193-7. 2002
....
Mortality risk in patients with schizophrenia participating in premarketing atypical antipsychotic clinical trialsArif Khan
Northwest Clinical Research Center, Bellevue, Wash, USA
J Clin Psychiatry 68:1828-33. 2007
....
Differential pattern of response in mood symptoms and suicide risk measures in severely ill depressed patients assigned to citalopram with placebo or citalopram combined with lithium: role of lithium levelsArif Khan
Northwest Clinical Research Center, Bellevue, WA 98007, USA
J Psychiatr Res 45:1489-96. 2011
..Further, lithium when used in therapeutic doses may augment such effects. These data warrant further exploration of lithium and an antidepressant combination for anti-suicidal effects...
Why has the antidepressant-placebo difference in antidepressant clinical trials diminished over the past three decades?Arif Khan
Northwest Clinical Research Center, Bellevue, WA 98007, USA
CNS Neurosci Ther 16:217-26. 2010
..Further, these data suggest that the results of more recent placebo controlled trials do not adequately inform clinicians about the potential utility of antidepressants...
Double-blind comparison of escitalopram and duloxetine in the acute treatment of major depressive disorderArif Khan
Northwest Clinical Research Center, Bellevue, WA 98004, USA
Clin Drug Investig 27:481-92. 2007
..This study evaluated the efficacy and safety of escitalopram versus duloxetine in the acute treatment of patients with moderate to severe major depressive disorder...
Research design features and patient characteristics associated with the outcome of antidepressant clinical trialsArif Khan
Northwest Clinical Research Center, Number 112, 1900 116th Avenue NE, Bellevue, WA 98004, USA
Am J Psychiatry 161:2045-9. 2004
..The authors examined which, if any, research design features and patient characteristics would significantly differ between successful and unsuccessful antidepressant trials...
An application of the revised CONSORT standards to FDA summary reports of recently approved antidepressants and antipsychoticsArif Khan
Northwest Clinical Research Center, Bellevue, Washington 98004, USA
Biol Psychiatry 52:62-7. 2002
..With minor changes in the preparation of reporting by using CONSORT or similar guidelines, the data would be even more valuable...
A randomized, double-blind, placebo-controlled, 8-week study of vilazodone, a serotonergic agent for the treatment of major depressive disorderArif Khan
Northwest Clinical Research Center, 1951 152nd Pl NE, Ste 200, Bellevue, WA 98007, USA
J Clin Psychiatry 72:441-7. 2011
..To evaluate the efficacy, and further establish the safety profile, of oral once-daily vilazodone, a potent and selective serotonin 1A receptor partial agonist and reuptake inhibitor, in the treatment of major depressive disorder (MDD)...
Study designs and outcomes in antidepressant clinical trialsArif Khan
Northwest Clinical Research Center, Bellevue, WA, USA
Essent Psychopharmacol 6:221-6. 2005
..Flexible dosing paradoxically reduces the response to placebo without augmenting the response to the antidepressant. All of these findings suggest that the use of placebo is mandatory when assessing new antidepressants...
Magnitude of placebo response and drug-placebo differences across psychiatric disordersArif Khan
Northwest Clinical Research Center, Bellevue, WA, USA
Psychol Med 35:743-9. 2005
..Placebo response, drug response, and drug-placebo differences appear to vary among psychiatric conditions...
The persistence of the placebo response in antidepressant clinical trialsArif Khan
Northwest Clinical Research Center, Bellevue, WA 98004, USA
J Psychiatr Res 42:791-6. 2008
..The widely held belief that the placebo response in depression is short-lived appears to be based largely on intuition and perhaps wishful thinking...
A systematic review of comparative efficacy of treatments and controls for depressionArif Khan
Northwest Clinical Research Center, Bellevue, Washington, United States of America
PLoS ONE 7:e41778. 2012
..We hypothesized that the differences between approved depression treatments and controls would be small...
Placebo response in depression: a perspective for clinical practiceArif Khan
Northwest Clinical Research Center, Bellevue, WA, USA
Psychopharmacol Bull 41:91-8. 2008
..For the practicing clinician, the best available data suggest that clinically depressed patients warrant treatment and the most robust available body of data (published and unpublished) would favor the use of antidepressants...
Relative sensitivity of the Montgomery-Asberg depression rating scale, the Hamilton depression rating scale and the Clinical Global Impressions rating scale in antidepressant clinical trials: a replication analysisArif Khan
North west Clinical Research Center, Bellevue, Washington, USA
Int Clin Psychopharmacol 19:157-60. 2004
..01). Further research is needed to examine which scale is the most appropriate to use for each particular antidepressant clinical trial...
Frequency of positive studies among fixed and flexible dose antidepressant clinical trials: an analysis of the food and drug administration summary basis of approval reportsArif Khan
Northwest Clinical Research Center, Bellevue, WA, USA
Neuropsychopharmacology 28:552-7. 2003
..05) compared to fixed dose trials. Symptom reduction was similar with antidepressants in the flexible and fixed dose trials. Further, the primary function of finding a dose-response relationship was not found among the fixed dose studies...
Outcome measures and serious asthma exacerbation in clinical trials of asthma controller medicationsJoshua P Schilling
Northwest Clinical Research Center, 1951 152nd Pl N E, Bellevue, WA 98007, USA
Ann Allergy Asthma Immunol 108:448-53. 2012
..With the introduction and approval of several new asthma controller medications for pediatric use, the risk-benefit ratio of these medications has not been fully evaluated...
Are the colors and shapes of current psychotropics designed to maximize the placebo response?Arif Khan
Northwest Clinical Research Center, 1951 152nd Pl NE 200, Bellevue, WA 98007, USA
Psychopharmacology (Berl) 211:113-22. 2010
..Patient expectations are an important aspect of the placebo response. Color and shape of a medication lead to perceptions that an agent is stimulating or calming, strong or weak...
Vilazodone, a novel dual-acting serotonergic antidepressant for managing major depressionArif Khan
Northwest Clinical Research Center, Bellevue, WA 98004, USA
Expert Opin Investig Drugs 18:1753-64. 2009
..Vilazodone offers a dual mechanism of action, good general tolerability with the potential for less impairment of sexual function than selective serotonin reuptake inhibitors and the possibility of personalized treatment for MDD...
Efficacy and safety of anti-manic agents in children and adultsArif Khan
Northwest Clinical Research Center, Bellevue, Washington, U S A Department of Psychiatry and Behavioral Health, Duke University, Durham, North Carolina, U S A
Isr J Psychiatry Relat Sci 49:122-7. 2012
..The therapeutic profile of these anti-manic agents in children is notably better than that for some other psychotropic drugs, for example, antidepressants...
Medical aspects of capital punishment executionsArif Khan
Northwest Clinical Research Center, Bellevue, WA, USA
J Forensic Sci 47:847-51. 2002
..These data suggest that human executions are difficult to carry out. Human executions are associated with significant physical complications. These data may help inform future discussions on human executions...
Suicide risk in placebo vs active treatment in placebo-controlled trials for schizophreniaJitschak G Storosum
Medicines Evaluation Board of the Netherlands, Den Haag, The Netherlands
Arch Gen Psychiatry 60:365-8. 2003
..We tested whether the risk of suicide and attempted suicide in the placebo arms of placebo-controlled studies among patients with schizophrenia is higher than in the active treatment arms of such studies...
Seizure incidence in psychopharmacological clinical trials: an analysis of Food and Drug Administration (FDA) summary basis of approval reportsKenneth Alper
Department of Psychiatry, Comprehensive Epilepsy Center, New York University School of Medicine, New York, NY 10016, USA
Biol Psychiatry 62:345-54. 2007
..Clinical trial data provide an approach to the investigation of the effects of psychopharmacological agents, and psychiatric disorders themselves, on seizure threshold...