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Edmund P. Harrigan - One of the best experts on this subject based on the ideXlab platform.
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The tolerability of intramuscular Ziprasidone and haloperidol treatment and the transition to oral therapy.
International clinical psychopharmacology, 2004Co-Authors: David G. Daniel, Dan L. Zimbroff, Rachel H. Swift, Edmund P. HarriganAbstract:Abstract The intramuscular (i.m.) formulation of Ziprasidone offers promise as an alternative to conventional i.m. agents for the short-term management of agitated patients with psychosis. This 7-day, randomized, open-label study evaluated the tolerability of Ziprasidone i.m. and haloperidol i.m. in hospitalized patients with a psychotic disorder and moderate psychopathology. Patients received three fixed doses of Ziprasidone i.m. 5 mg qid (n=69), 10mg qid (currently maximum recommended daily dose in USA; n=71), 20mg qid (n=66), or flexible-dose/ flexible-schedule haloperidol i.m. up to 10 mg bid-qid (n=100) for 3 days. This was followed by oral treatment with the same medication for 4 days. Ziprasidone i.m. was associated with a notably lower burden of movement disorders than haloperidol i.m. (mean 11 mg/day). No bradycardia, sinus pauses, disinhibition, confusion, excessive sedation or respiratory depression was observed with Ziprasidone. No safety issues were identified with the coadministration of lorazepam with the i.m. formulations of either agent. All three Ziprasidone i.m. doses and haloperidol i.m. maintained control of symptoms and, following the transition to oral treatment, symptoms remained controlled. Ziprasidone i.m. 5,10, and 20 mg qid, given for 3 days were well tolerated. The transition from i.m. to oral Ziprasidone was well tolerated with continuing maintenance of symptom control.
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intramuscular im Ziprasidone 20 mg is effective in reducing acute agitation associated with psychosis a double blind randomized trial
Psychopharmacology, 2001Co-Authors: David G. Daniel, Rachel H. Swift, Steven G Potkin, Karen R Reeves, Edmund P. HarriganAbstract:Rationale: Intramuscular (IM) conventional antipsychotics and/or benzodiazepines are effective in the short-term treatment of acutely agitated psychotic patients but may be associated with adverse effects. A short-acting IM formulation of the novel antipsychotic, Ziprasidone, which may offer advantages over conventional agents, has been developed. Objective: To compare Ziprasidone IM 2 mg (n=38) and 20 mg (n=41) in the acute control and short-term management of agitated psychotic patients. Methods: A prospective, randomized, double-blind, 24-h study assessed efficacy using the Behavioral Activity Rating Scale (BARS) and the PANSS. The BARS is a validated rating scale for the assessment of treatment response in acute agitation associated with psychosis. Following the initial dose, three more doses could be given 4 h apart if needed during the 24-h period. Results: The mean BARS score had decreased 15 min after the first 20 mg IM dose and was statistically significantly lower than the 2 mg group at 30 min post-dose. The improvement with the 20 mg dose increased until 2 h, and was maintained until at least 4 h post-dose (P<0.001). Two hours after the first injection, almost all of the patients receiving Ziprasidone 20 mg were BARS responders compared with just one-third of those receiving 2 mg Ziprasidone (P<0.001). The calming effect of Ziprasidone was also evident by the significant reduction in PANSS agitation items (P<0.05) and CGI-severity at 4 h (P=0.008). Both Ziprasidone doses were very well tolerated. Ziprasidone IM 20 mg was not associated with EPS, dystonia, akathisia, respiratory depression or with excessive sedation. Conclusions: Ziprasidone IM 20 mg substantially and significantly reduced the symptoms of acute agitation in patients with psychotic disorders. Ziprasidone 20 mg IM was very well tolerated and produced no dystonia or akathisia.
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Ziprasidone 80 mg day and 160 mg day in the acute exacerbation of schizophrenia and schizoaffective disorder a 6 week placebo controlled trial
Neuropsychopharmacology, 1999Co-Authors: David G. Daniel, Dan L. Zimbroff, Edmund P. Harrigan, Steven G Potkin, Karen R Reeves, Mani LakshminarayananAbstract:In this double-blind study, patients with an acute exacerbation of schizophrenia or schizoaffective disorder were randomized to receive either Ziprasidone 80 mg/day (n = 106) or 160 mg/day (n = 104) or placebo (n = 92), for 6 weeks. Both doses of Ziprasidone were statistically significantly more effective than placebo in improving the PANSS total, BPRS total, BPRS core items, CGI-S, and PANSS negative subscale scores (p or = 14, over-all mean 23.5) (p < .05) as compared with placebo. The percentage of patients experiencing adverse events was similar in each treatment group, and resultant discontinuation was rare. The most frequent adverse events associated with Ziprasidone were generally mild dyspepsia, nausea, dizziness, and transient somnolence. Ziprasidone was shown to have a very low liability for inducing movement disorders and weight gain. The results indicate that Ziprasidone is effective and well tolerated in the treatment of the positive, negative, and depressive symptoms of an acute exacerbation of schizophrenia or schizoaffective disorder.
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Ziprasidone 40 and 120 mg day in the acute exacerbation of schizophrenia and schizoaffective disorder a 4 week placebo controlled trial
Psychopharmacology, 1998Co-Authors: Paul E Keck, Edmund P. Harrigan, Alan Buffenstein, James Ferguson, John P Feighner, William Jaffe, Marilyn R MorrisseyAbstract:A double-blind, placebo-controlled, multicenter study, was performed to evaluate the efficacy and safety of Ziprasidone in 139 patients with an acute exacerbation of schizophrenia or schizoaffective disorder. Patients were randomized to receive Ziprasidone 40 mg/day, 120 mg/day or placebo for 28 days. Ziprasidone 120 mg/day was significantly more effective than placebo in improving the BPRS total, CGI-S, BPRS depression cluster and BPRS anergia cluster scores (all P < 0.05). Similarly, the percentages of patients classified as responders on the BPRS (≥30% reduction) and the CGI improvement (score ≤2) were significantly greater with Ziprasidone 120 mg/day compared with placebo (P < 0.05). The number of patients who experienced an adverse event was similar in all three treatment groups, and discontinuation due to adverse events was rare (five of 91 Ziprasidone-treated patients). The most frequently reported adverse events, that were more common in either Ziprasidone group than in the placebo group, were dyspepsia, constipation, nausea and abdominal pain. There was a notably low incidence extrapyramidal side-effects (including akathisia) and postural hypotension and no pattern of laboratory abnormalities or apparent weight gain. Ziprasidone-treated patients were not clinically different from placebo-treated patients on the Simpson-Angus Rating scale, Barnes Akathisia scale and AIMS assessments. These results indicate that Ziprasidone 120 mg/day is effective in the treatment of the positive, negative and affective symptoms of schizophrenia and schizoaffective disorder with a very low side-effect burden.
David G. Daniel - One of the best experts on this subject based on the ideXlab platform.
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from clinical research to clinical practice a 4 year review of Ziprasidone
Cns Spectrums, 2005Co-Authors: Charles B. Nemeroff, Peter J Weiden, Jeffrey A Lieberman, Philip D Harvey, John W Newcomer, Alan F Schatzberg, Clinton D Kilts, David G. DanielAbstract:Ziprasidone is a second-generation antipsychotic that received Food and Drug Administration approval in February 2001. It has a unique receptor profile that includes high-affinity antagonist activity at dopamine D2 receptors, inverse agonist activity at serotonin (5-HT)2A receptors, agonist activity at 5-HTlA receptors, and a relatively high affinity for the serotonin and norepinephrine transporters. The 5-HTIA affinity, together with the inhibitory effect on mono-amine reuptake, may underlie the hypothesized beneficial effects on comorbid affective and cognitive abnormalities in schizophrenia and schizoaffective disorder. The short-term efficacy of Ziprasidone for core positive symptoms of schizophrenia appears to be comparable to other conventional and atypical antipsychotics. The short-term efficacy of Ziprasidone in acute mania has been established based on two 3-week, double-blind, placebo-controlled trials.Open-label treatment for up to 52 weeks confirms the sustained efficacy and safety of Ziprasidone in bipolar disorder. Maintenance studies in schizophrenia and schizoaffective disorder indicate that long-term Ziprasidone therapy is effective in preventing relapse, while maintaining cognitive and psychosocial benefits. The safety database suggests that the overall cardiovascular and cerebrovascular risk associated with Ziprasidone is lower than with other atypicals, with notably lower risk of drug-related increases in weight, glucose, or lipids. The data also suggest a modestly increased risk of QTc prolongation that is not dose related or linked to torsades de pointes. Switching to Ziprasidone from other atypicals appears to improve both clinical symptoms and metabolic parameters, though more studies are needed to fully characterize these benefits. This monograph summarizes the efficacy, tolerability, and safety of oral Ziprasidone in the treatment of schizophrenia, schizoaffective disorder, and bipolar mania.
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The tolerability of intramuscular Ziprasidone and haloperidol treatment and the transition to oral therapy.
International clinical psychopharmacology, 2004Co-Authors: David G. Daniel, Dan L. Zimbroff, Rachel H. Swift, Edmund P. HarriganAbstract:Abstract The intramuscular (i.m.) formulation of Ziprasidone offers promise as an alternative to conventional i.m. agents for the short-term management of agitated patients with psychosis. This 7-day, randomized, open-label study evaluated the tolerability of Ziprasidone i.m. and haloperidol i.m. in hospitalized patients with a psychotic disorder and moderate psychopathology. Patients received three fixed doses of Ziprasidone i.m. 5 mg qid (n=69), 10mg qid (currently maximum recommended daily dose in USA; n=71), 20mg qid (n=66), or flexible-dose/ flexible-schedule haloperidol i.m. up to 10 mg bid-qid (n=100) for 3 days. This was followed by oral treatment with the same medication for 4 days. Ziprasidone i.m. was associated with a notably lower burden of movement disorders than haloperidol i.m. (mean 11 mg/day). No bradycardia, sinus pauses, disinhibition, confusion, excessive sedation or respiratory depression was observed with Ziprasidone. No safety issues were identified with the coadministration of lorazepam with the i.m. formulations of either agent. All three Ziprasidone i.m. doses and haloperidol i.m. maintained control of symptoms and, following the transition to oral treatment, symptoms remained controlled. Ziprasidone i.m. 5,10, and 20 mg qid, given for 3 days were well tolerated. The transition from i.m. to oral Ziprasidone was well tolerated with continuing maintenance of symptom control.
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intramuscular im Ziprasidone 20 mg is effective in reducing acute agitation associated with psychosis a double blind randomized trial
Psychopharmacology, 2001Co-Authors: David G. Daniel, Rachel H. Swift, Steven G Potkin, Karen R Reeves, Edmund P. HarriganAbstract:Rationale: Intramuscular (IM) conventional antipsychotics and/or benzodiazepines are effective in the short-term treatment of acutely agitated psychotic patients but may be associated with adverse effects. A short-acting IM formulation of the novel antipsychotic, Ziprasidone, which may offer advantages over conventional agents, has been developed. Objective: To compare Ziprasidone IM 2 mg (n=38) and 20 mg (n=41) in the acute control and short-term management of agitated psychotic patients. Methods: A prospective, randomized, double-blind, 24-h study assessed efficacy using the Behavioral Activity Rating Scale (BARS) and the PANSS. The BARS is a validated rating scale for the assessment of treatment response in acute agitation associated with psychosis. Following the initial dose, three more doses could be given 4 h apart if needed during the 24-h period. Results: The mean BARS score had decreased 15 min after the first 20 mg IM dose and was statistically significantly lower than the 2 mg group at 30 min post-dose. The improvement with the 20 mg dose increased until 2 h, and was maintained until at least 4 h post-dose (P<0.001). Two hours after the first injection, almost all of the patients receiving Ziprasidone 20 mg were BARS responders compared with just one-third of those receiving 2 mg Ziprasidone (P<0.001). The calming effect of Ziprasidone was also evident by the significant reduction in PANSS agitation items (P<0.05) and CGI-severity at 4 h (P=0.008). Both Ziprasidone doses were very well tolerated. Ziprasidone IM 20 mg was not associated with EPS, dystonia, akathisia, respiratory depression or with excessive sedation. Conclusions: Ziprasidone IM 20 mg substantially and significantly reduced the symptoms of acute agitation in patients with psychotic disorders. Ziprasidone 20 mg IM was very well tolerated and produced no dystonia or akathisia.
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Ziprasidone 80 mg day and 160 mg day in the acute exacerbation of schizophrenia and schizoaffective disorder a 6 week placebo controlled trial
Neuropsychopharmacology, 1999Co-Authors: David G. Daniel, Dan L. Zimbroff, Edmund P. Harrigan, Steven G Potkin, Karen R Reeves, Mani LakshminarayananAbstract:In this double-blind study, patients with an acute exacerbation of schizophrenia or schizoaffective disorder were randomized to receive either Ziprasidone 80 mg/day (n = 106) or 160 mg/day (n = 104) or placebo (n = 92), for 6 weeks. Both doses of Ziprasidone were statistically significantly more effective than placebo in improving the PANSS total, BPRS total, BPRS core items, CGI-S, and PANSS negative subscale scores (p or = 14, over-all mean 23.5) (p < .05) as compared with placebo. The percentage of patients experiencing adverse events was similar in each treatment group, and resultant discontinuation was rare. The most frequent adverse events associated with Ziprasidone were generally mild dyspepsia, nausea, dizziness, and transient somnolence. Ziprasidone was shown to have a very low liability for inducing movement disorders and weight gain. The results indicate that Ziprasidone is effective and well tolerated in the treatment of the positive, negative, and depressive symptoms of an acute exacerbation of schizophrenia or schizoaffective disorder.
Leslie Citrome - One of the best experts on this subject based on the ideXlab platform.
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high dose oral Ziprasidone versus conventional dosing in schizophrenia patients with residual symptoms the zebras study
Journal of Clinical Psychopharmacology, 2013Co-Authors: Donald C Goff, Leslie Citrome, Joseph Patrick Mcevoy, Arnold W Mech, Juan R Bustillo, Roberto Gil, Peter F Buckley, Theo C Manschreck, Eric D Achtyes, Eric A MacklinAbstract:Uncontrolled studies have suggested that increasing the dose of Ziprasidone above the standard maximum daily dose of 160 mg may be more effective for some patients with schizophrenia. To test this hypothesis, we conducted an 8-week, placebo-controlled, fixed-dose escalation trial comparing Ziprasidone 160 versus 320 mg/d in individuals with schizophrenia or schizoaffective disorder who remained symptomatic despite treatment with Ziprasidone 160 mg/d for at least 3 weeks. Of 75 randomized patients, 42 completed the study. Serum Ziprasidone concentrations increased significantly in the high-dose group compared with the standard-dose group at week 4 but did not differ between groups at week 8. Both treatment groups exhibited significant symptomatic improvement. Response did not differ between treatment groups; however, in the high-dose group, higher Ziprasidone serum concentrations were associated with better response at a trend level. Higher Ziprasidone concentrations were also associated with reductions in diastolic blood pressure and, at a trend level, with more prominent negative symptoms and greater QTc prolongation. In summary, increasing the Ziprasidone dose to 320 mg/d did not produce a sustained elevation in serum concentrations or symptomatic improvement compared with a standard Ziprasidone dose of 160 mg/d.
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Drug safety evaluation of Ziprasidone.
Expert opinion on drug safety, 2011Co-Authors: Leslie CitromeAbstract:Introduction: Ziprasidone is a second-generation antipsychotic approved for the treatment of schizophrenia and bipolar disorder. The purpose of this review is to assess the overall safety profile of Ziprasidone, including its risk for prolonging the electrocardiogram (ECG) QT interval. Areas covered: This paper is a review of product labeling and English language reports located through PubMed and information available on regulatory agency websites, with a focus on the safety and tolerability of Ziprasidone. Expert opinion: Although Ziprasidone can prolong the ECG QT interval, this has not resulted in increases in sudden death or cardiac sudden death as noted in a large, simple trial and supported by almost a decade of real-world use in the US. Ziprasidone's principal advantage over some other second-generation antipsychotics has been its overall favorable weight and metabolic profile. Similar to most second-generation antipsychotics, Ziprasidone has a lower propensity for extrapyramidal side effects and ...
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Using oral Ziprasidone effectively: the food effect and dose-response
Advances in Therapy, 2009Co-Authors: Leslie CitromeAbstract:Ziprasidone is a newer “atypical” or “secondgeneration” antipsychotic. Oral Ziprasidone (zipras idone hydrochlor ide) has been approved by the US Food and Drug Administration (FDA) for the treatment of schizophrenia, and acute manic or mixed episodes associated with bipolar disorder (with or without psychotic features). Comparisons with other second-generation antipsychotics in meta-analyses reveal similar efficacy to that observed for quetiapine or aripiprazole, but inferior efficacy to that of olanzapine or risperidone in the treatment of schizophrenia. However, the rate of dose titration and the dose achieved may have an important bearing on Ziprasidone’s efficacy profile, with a target dose range of 120-160 mg/day being associated with optimal symptom control and greater persistence with treatment. In addition, enhancing Ziprasidone’s effectiveness requires ensuring that Ziprasidone is administered with a 500 kcal meal; otherwise, absorption of oral Ziprasidone is substantially reduced and cannot be compensated for by increasing the prescribed dose. Regarding tolerability, Ziprasidone has important advantages in that it is not associated with clinically significant weight gain or adverse changes in cholesterol, triglycerides, or glycemic control, and patients may experience moderate improvement in these measures when switching to Ziprasidone from a different antipsychotic. Ziprasidone also lacks significant persistent effects on prolactin levels, is not anticholinergic, and only infrequently causes extrapyramidal side effects or postural hypotension; however, it can be associated with somnolence. Ziprasidone may prolong the electrocardiogram (ECG) QT interval but this does not appear to pose a substantial clinical problem. Provided that an adequate dose of Ziprasidone is prescribed, and administered with a 500 kcal meal, Ziprasidone can be effectively used to control symptoms without the long-term liabilities of metabolic side effects.
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how dosing of Ziprasidone in a state hospital system differs from product labeling
The Journal of Clinical Psychiatry, 2009Co-Authors: Leslie Citrome, Ari Jaffe, Jerome LevineAbstract:BACKGROUND The purpose of this article is to review the utilization and dosing of Ziprasidone in a state hospital system and to compare the dosing to dosing recommendations contained in product labeling that suggest a starting dose of 40 mg/day and a target dose range of 40 to 160 mg/day for schizophrenia. METHOD Dosing of Ziprasidone was examined from the time when it was first marketed in 2001 up to and including calendar year 2006 using a database that contains patient information and drug prescription information for every inpatient within the adult civil facilities of the New York State psychiatric hospital system operated by the New York State Office of Mental Health. Supporting evidence for a therapeutic dose response for Ziprasidone was examined by conducting a PubMed search for the period January 1, 1990, to June 1, 2008, identifying English-language articles related to Ziprasidone dose in schizophrenia using the search terms Ziprasidone, dose, and schizophrenia. RESULTS Although the highest efficacious dose of Ziprasidone recommended in the manufacturer's product label is 160 mg/day, the mean dose of Ziprasidone prescribed among patients hospitalized in New York State in calendar year 2006 and receiving antipsychotic medication (N = 7154) was 179 mg/day (N = 709), with 51.6% receiving doses in excess of 160 mg/day (N = 366). Patients discharged on treatment with Ziprasidone (N = 189) received a mean dose of 206 mg/day. Patients with schizophrenia with a history of prior state hospital admission were more likely to receive doses greater than 160 mg/day. Clinicians in hospitals with the highest prescribing rates for Ziprasidone were more likely to prescribe Ziprasidone in excess of 160 mg/day. The initial dose on the first day for new starts on treatment with Ziprasidone was 91 mg/day (N = 112). Published anecdotal reports describe the use of Ziprasidone in excess of 160 mg/day and up to 640 mg/day among patients not responding to lower doses, but, currently, there are no published reports from double-blind randomized clinical trials establishing the utility of this high-dose treatment strategy. CONCLUSIONS Dosing of Ziprasidone in a large state hospital system is higher than what has been established in the registration program for schizophrenia. Although there is anecdotal evidence describing the use of Ziprasidone in excess of 160 mg/day, controlled clinical trials are needed to determine if these higher doses are more effective.
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Ziprasidone for Schizophrenia and Bipolar Disorder: A Review of the Clinical Trials
CNS drug reviews, 2007Co-Authors: William M. Greenberg, Leslie CitromeAbstract:Ziprasidone is a newer "atypical" or "second-generation" antipsychotic. Oral Ziprasidone (Ziprasidone hydrochloride) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia, and acute manic or mixed episodes associated with bipolar disorder (with or without psychotic features). Ziprasidone intramuscular (Ziprasidone mesylate) is FDA-approved for acute agitation in patients with schizophrenia. Oral Ziprasidone appears efficacious, and has been shown to have some limited clinical advantages over chlorpromazine and haloperidol in ameliorating negative symptoms of schizophrenia. In Phase 2 of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) for schizophrenia, Ziprasidone did not match the clinical performance of olanzapine and risperidone, appearing closer in overall effectiveness to quetiapine. The rate of dose titration and the dose achieved may have an important bearing on Ziprasidone's efficacy profile. In studies of usage for acute agitation in individuals with schizophrenia, intramuscular Ziprasidone has been shown to be efficacious and relatively well tolerated. Regarding tolerability, Ziprasidone, has important advantages in that it is not associated with clinically significant weight gain or adverse changes in cholesterol, triglycerides, or glycemic control, and patients may experience moderate improvement in these measures when switching to Ziprasidone from a different antipsychotic agent. It also lacks significant persistent effects on prolactin levels, is not anticholinergic, and only infrequently causes extrapyramidal side effects or postural hypotension, although it can be associated with somnolence. This tolerability profile may be quite valuable in the treatment of some patients. Ziprasidone may prolong the electrocardiogram (ECG) QTc interval (QT interval corrected for heart rate by a standard algorithm), but after 5 years' clinical availability Ziprasidone (by itself) does not appear to pose a substantial clinical problem in this regard. Therefore, Ziprasidone may be considered a first-line drug option in the treatment of schizophrenia or manic episodes, but, in view of the differences among antipsychotic medications, drug selection should be guided by the patient's individual characteristics and situation.
Michelle H Biros - One of the best experts on this subject based on the ideXlab platform.
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randomized double blind trial of intramuscular droperidol Ziprasidone and lorazepam for acute undifferentiated agitation in the emergency department
Academic Emergency Medicine, 2020Co-Authors: Marc L Martel, James R Miner, Michelle H Biros, Brian E Driver, Jon B ColeAbstract:BACKGROUND The optimal agent to treat acute agitation in the emergency department (ED) has not been determined. The objective of this study was to compare the effectiveness and safety of intramuscular droperidol, Ziprasidone, and lorazepam for acute agitation in the ED. METHODS This was a randomized, double-blind trial of ED patients with acute agitation requiring parenteral sedation. The study was conducted under exception from informed consent (21 CFR 50.24) from July 2004 to March 2005. Patients were randomized to receive 5 mg of droperidol, 10 mg of Ziprasidone, 20 mg of Ziprasidone, or 2 mg of lorazepam intramuscularly. We recorded Altered Mental Status Scale (AMSS) scores, nasal end-tidal carbon dioxide (ETCO2 ), and pulse oximetry (SpO2 ) at 0, 15, 30, 45, 60, 90, and 120 minutes as well as QTc durations and dysrhythmias. Respiratory depression was defined as a change in ETCO2 consistent with respiratory depression or SpO2 < 90%. The primary outcome was the proportion of patients adequately sedated (AMSS ≤ 0) at 15 minutes. RESULTS We enrolled 115 patients. Baseline AMSS scores were similar between groups. For the primary outcome, adequate sedation at 15 minutes, droperidol administration was effective in 16 of 25 (64%) patients, compared to seven of 28 (25%) for 10 mg of Ziprasidone, 11 of 31 (35%) for 20 mg of Ziprasidone, and nine of 31 (29%) for lorazepam. Pairwise comparisons revealed that droperidol was more effective that the other medications, with 39% (95% confidence interval [CI] = 3% to 54%) more compared to 20 mg of Ziprasidone and 33% (95% CI = 8% to 58%) more compared to lorazepam. There was no significant difference between groups in need of additional rescue sedation. Numerically, respiratory depression was lower with droperidol (3/25 [12%]) compared to 10 mg of Ziprasidone (10/28 [36%]), 20 mg of Ziprasidone (12/31 [39%]), or lorazepam (15/31 [48%]). One patient receiving 20 mg of Ziprasidone required intubation to manage an acute subdural hematoma. No patients had ventricular dysrhythmias. QTc durations were similar in all groups. CONCLUSIONS Droperidol was more effective than lorazepam or either dose of Ziprasidone for the treatment of acute agitation in the ED and caused fewer episodes of respiratory depression.
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management of acute undifferentiated agitation in the emergency department a randomized double blind trial of droperidol Ziprasidone and midazolam
Academic Emergency Medicine, 2005Co-Authors: Marc L Martel, Ann Sterzinger, James R Miner, Joseph E Clinton, Michelle H BirosAbstract:Objectives: To compare the efficacy of sedation, need for rescue sedation, rates of respiratory depression, and complications of droperidol, Ziprasidone, and midazolam when used for the treatment of emergency department (ED) patients requiring sedation for acute undifferentiated agitation. Methods: A prospective, randomized, double-blind trial of agitated ED patients requiring emergent sedation was performed. Patients were randomized to receive droperidol 5 mg, Ziprasidone 20 mg, or midazolam 5 mg intramuscularly. Interval measurements were made at 0, 15, 30, 45, 60, and 120 minutes and included Altered Mental Status Scale (AMS) scores, oxygen saturations, and end-tidal carbon dioxide levels. Results: A total of 144 patients were enrolled; 50 patients received droperidol, 46 received Ziprasidone, and 48 received midazolam. Adequate sedation (mean AMS score <0) was achieved at 15 minutes in patients receiving midazolam (mean AMS score, −0.81) and 30 minutes for patients receiving droperidol (mean AMS score, −1.3) and Ziprasidone (mean AMS score, −0.74). Rescue medication for sedation was necessary in 38 of 144 patients (droperidol, 5 of 50; Ziprasidone, 9 of 46; midazolam, 24 of 48; p < 0.05). No cardiac dysrhythmias were identified in any treatment group. Respiratory depression that clinically required treatment with supplemental oxygen occurred in 21 of 144 patients (droperidol, 4 of 50; Ziprasidone, 7 of 46; midazolam, 10 of 48; p = 0.20). No patients required endotracheal intubation. Conclusions: Acutely agitated ED patients sedated with droperidol or Ziprasidone required rescue medications to achieve adequate sedation less frequently than those sedated with midazolam. The onset of adequate sedation is delayed with Ziprasidone, relative to the other agents.
Eduard Vieta - One of the best experts on this subject based on the ideXlab platform.
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Ziprasidone in the treatment of acute mania a 12 week placebo controlled haloperidol referenced study
Journal of Psychopharmacology, 2010Co-Authors: Eduard Vieta, T Ramey, D Keller, P A English, Antony Loebel, J MiceliAbstract:This 12-week, double-blind, two-part study in 438 adults with bipolar-associated acute mania began with a 3-week period comparing Ziprasidone (80—160 mg/day) and placebo with haloperidol (8—30 mg/day) as active reference. Changes from baseline Mania Rating Scale (MRS) scores for Ziprasidone and haloperidol were superior to placebo from day 2 (P = 0.001) to week 3 (P < 0.001); change from baseline at week 3 was greater for haloperidol than Ziprasidone (P ≤ 0.001). At week 3, the response rate (≥50% decrease from baseline MRS score) was 36.9, 54.7 and 20.5% for Ziprasidone, haloperidol and placebo, respectively (P ≤ 0.05, active treatments versus placebo and Ziprasidone versus haloperidol). In the 9-week extension phase, Ziprasidone replaced placebo to examine tolerability. Maintenance of improvement was evaluated for Ziprasidone (40—160 mg/day) or haloperidol (4—30 mg/day). Responses were maintained through the last visit for 88.1% receiving Ziprasidone and 96.3% receiving haloperidol. More patients receiv...
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Ziprasidone plus a mood stabilizer in subjects with bipolar i disorder a 6 month randomized placebo controlled double blind trial
The Journal of Clinical Psychiatry, 2010Co-Authors: Charles L Bowden, Eduard Vieta, Kathleen S Ice, Jeffrey H Schwartz, Paul P Wang, Mark VersavelAbstract:Objective To evaluate the efficacy and safety of Ziprasidone adjunctive to a mood stabilizer for the maintenance treatment of bipolar mania. Method Subjects with DSM-IV bipolar I disorder with a Mania Rating Scale score > or = 14 were enrolled. Subjects achieving > or = 8 consecutive weeks of stability with open-label Ziprasidone (80-160 mg/d) and lithium or valproate (period 1) were randomly assigned in the 6-month, double-blind maintenance period (period 2) to Ziprasidone plus mood stabilizer or placebo plus mood stabilizer. The primary and key secondary end points were the time to intervention for a mood episode and time to discontinuation for any reason, respectively. Inferential analysis was performed using a Kaplan-Meier product-limit estimator (log-rank test). The study was conducted from December 2005 to May 2008. Results A total of 127 and 113 subjects were randomly assigned to Ziprasidone and placebo, respectively. Intervention for a mood episode was required in 19.7% and 32.4% of Ziprasidone and placebo subjects, respectively. The time to intervention for a mood episode was significantly longer for Ziprasidone than placebo (P = .0104). The median time to intervention for a mood episode among those requiring such an intervention (n = 61) was 43.0 days for Ziprasidone versus 26.5 days for placebo. The time to discontinuation for any reason was significantly longer for Ziprasidone (P = .0047). Adjunctive Ziprasidone treatment was well tolerated. Among treatment-emergent adverse events occurring in > or = 5% of subjects in either treatment group during period 2, only tremor occurred more frequently in the Ziprasidone versus placebo group (6.3% vs 3.6%). Conclusions Ziprasidone is an effective, safe, and well-tolerated adjunctive treatment with a mood stabilizer for long-term maintenance treatment of bipolar mania. Trial registration clinicaltrials.gov Identifier: NCT00280566.
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Ziprasidone in the Treatment of Affective Disorders: A Review
CNS neuroscience & therapeutics, 2008Co-Authors: Adriane R. Rosa, Carolina Franco, Carla Torrent, Mercè Comes, Nuria Cruz, Guillermo Horga, Antonio Benabarre, Eduard VietaAbstract:Ziprasidone was the fifth atypical antipsychotic approved by Food and Drug Administration (FDA) for use in bipolar mania and mixed episodes. This atypical antipsychotic has a unique profile, as it acts primarily through serotonergic and dopaminergic receptor antagonism, but also exerts effects as an inhibitor of norepinephrine reuptake. Moreover, one of the advantages of Ziprasidone is its safety profile as it is not associated with clinically significant metabolic side effects and little or no effect on prolactin level or anticholinergic side effects. Most of the studies evaluating Ziprasidone's efficacy and safety are short-term double-blind, placebo-controlled studies in acute mania and mixed episodes. In two of them, Ziprasidone was associated to significant improvement in the primary measures assessed. However, an add-on study, lithium plus Ziprasidone showed similar results than lithium monotherapy, although there was a significant advantage for the combination within the first week. In a more recent trial, Ziprasidone was compared with placebo and haloperidol as monotherapies, again beating placebo. In that trial, Ziprasidone appeared to be safer and better tolerated, although less likely efficacious than haloperidol. Particularly, subjects treated with Ziprasidone were less likely to switch to depression. Despite the well-studied efficacy of Ziprasidone in the first weeks of treatment, there are no controlled trials that evaluate the role and efficacy of Ziprasidone in long-term treatment of bipolar disorder (BD). Overall, in the open-label extension studies, there was a global improvement at all visits compared with baseline scores. Furthermore, Ziprasidone appears to offer some antidepressant effect in patients with major depressive episode and resistant to treatment, as demonstrated in add-on open-label studies with Ziprasidone plus selective serotonin reuptake inhibitor (SSRI).
