Ziprasidone vs clozapine in schizophrenia patients refractory to multiple antipsychotic treatments: The MOZART study

Sacchetti, Emilio; Galluzzo, Alessandro; Valsecchi, Paolo; Romeo, Fabio; Gorini, Barbara; Warrington, Lewis

doi:10.1016/j.schres.2009.02.017

Cited by 37 publications

(21 citation statements)

References 61 publications

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“…Most reports indicate a low incidence of PRL elevation and low to moderate levels of HPRL with ziprasidone use [11, 15, 103, 234, 240, 245, 297, 324–326]. Several studies found decreased PRL levels after, respectively, 6 weeks [301], 4–8 weeks [90], 18 weeks [327], 44 weeks [328] and 1 year [329] of treatment with ziprasidone. However, ziprasidone can also be associated with HPRL.…”

Section: Prl and Antipsychoticsmentioning

confidence: 99%

The Effects of Novel and Newly Approved Antipsychotics on Serum Prolactin Levels: A Comprehensive Review

et al. 2014

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Since the 1970s, clinicians have increasingly become more familiar with hyperprolactinemia (HPRL) as a common adverse effect of antipsychotic medication, which remains the cornerstone of pharmacological treatment for patients with schizophrenia. Although treatment with second-generation antipsychotics (SGAs) as a group is, compared with use of the first-generation antipsychotics, associated with lower prolactin (PRL) plasma levels, the detailed effects on plasma PRL levels for each of these compounds in reports often remain incomplete or inaccurate. Moreover, at this moment, no review has been published about the effect of the newly approved antipsychotics asenapine, iloperidone and lurasidone on PRL levels. The objective of this review is to describe PRL physiology; PRL measurement; diagnosis, causes, consequences and mechanisms of HPRL; incidence figures of (new-onset) HPRL with SGAs and newly approved antipsychotics in adolescent and adult patients; and revisit lingering questions regarding this hormone. A literature search, using the MEDLINE database (1966–December 2013), was conducted to identify relevant publications to report on the state of the art of HPRL and to summarize the available evidence with respect to the propensity of the SGAs and the newly approved antipsychotics to elevate PRL levels. Our review shows that although HPRL usually is defined as a sustained level of PRL above the laboratory upper limit of normal, limit values show some degree of variability in clinical reports, making the interpretation and comparison of data across studies difficult. Moreover, many reports do not provide much or any data detailing the measurement of PRL. Although the highest rates of HPRL are consistently reported in association with amisulpride, risperidone and paliperidone, while aripiprazole and quetiapine have the most favorable profile with respect to this outcome, all SGAs can induce PRL elevations, especially at the beginning of treatment, and have the potential to cause new-onset HPRL. Considering the PRL-elevating propensity of the newly approved antipsychotics, evidence seems to indicate these agents have a PRL profile comparable to that of clozapine (asenapine and iloperidone), ziprasidone and olanzapine (lurasidone). PRL elevations with antipsychotic medication generally are dose dependant. However, antipsychotics having a high potential for PRL elevation (amisulpride, risperidone and paliperidone) can have a profound impact on PRL levels even at relatively low doses, while PRL levels with antipsychotics having a minimal effect on PRL, in most cases, can remain unchanged (quetiapine) or reduce (aripiprazole) over all dosages. Although tolerance and decreases in PRL values after long-term administration of PRL-elevating antipsychotics can occur, the elevations, in most cases, remain above the upper limit of normal. PRL profiles of antipsychotics in children and adolescents seem to be the same as in adults. The hyperprolactinemic effects of antipsychotic medication are mostly correlated with their affi...

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Section: Prl and Antipsychoticsmentioning

confidence: 99%

The Effects of Novel and Newly Approved Antipsychotics on Serum Prolactin Levels: A Comprehensive Review

et al. 2014

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“…This figure appears consistent with rates observed in more recent individual studies (e.g. Emsley et al ., ; Trueur et al ., ; Kane et al ., ; Sacchetti et al ., ). Although marginally lower than similar estimates of medication non‐compliance in the community setting of around 42% (Cramer & Rosenheck, ), these figures still represent an important and significant proportion of study cohorts that withdraw from analysis over the course of time.…”

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confidence: 97%

Who's left? Symptoms of schizophrenia that predict clinical trial dropout

Thompson

Berk

Dean

et al. 2011

Human Psychopharmacology

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A significant proportion of subjects drop out of medium to long-term clinical studies prior to trial completion. This may bias reported study outcomes and reduce the statistical power of analyses. There is therefore a need for researchers to better understand the characteristics of dropout populations to increase completion rates. Data from a set of participants recruited as part of a 24-week placebo-controlled trial were used to determine the relationship between the five Lindenmayer factors of positive, negative, cognitive, anxiety/depression and excitement symptoms and dropout at trial completion. Results indicated that the rate of trial dropout was significantly predicted by scores on the negative Lindenmayer factor (X² (6, N = 126) = 15.60, p < .05). By trial completion, participants with 'high' negative Lindenmayer scores dropped out at a rate of 64%, whereas 'medium' and 'low' groups dropped out at 43% and 30%, respectively. No other relationship between symptom severity scores and dropout across the remaining Lindenmayer factors was found. These findings reflect important considerations for the future design of clinical trials involving people with schizophrenia and may also provide clues into treatment compliance issues more generally.

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“…Olanzapine was also associated with fewer hospitalizations [27]. One of the included trials comparing ziprasidone to clozapine in a head-to-head, randomized, double-blind study of 18 weeks in treatment refractory patients showed similar reductions in PANSS scores with ziprasidone and clozapine [28]. Further head-to-head trials are warranted to replicate these unexpected findings.…”

Section: Resultsmentioning

confidence: 99%

Evidence review and clinical guidance for the use of ziprasidone in Canada

et al. 2013

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While indicated for schizophrenia and acute mania, ziprasidone’s evidence base and use in clinical practice extends beyond these regulatory approvals. We, an invited panel of experts led by a working group of 3, critically examined the evidence and our collective experience regarding the effectiveness, tolerability and safety of ziprasidone across its clinical uses. There was no opportunity for manufacturer input into the content of the review. As anticipated, ziprasidone was found to be effective for its indicated uses, although its utility in mania and mixed states lacked comparative data. Beyond these uses, the available data were either unimpressive or were lacking. An attractive characteristic is its neutral effect on weight thereby providing patients with a non-obesogenic long-term treatment option. Key challenges in practice include the need for dosing on a full stomach and managing its early onset adverse effect of restlessness. Addressing these issues are critical to its long-term success

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Ziprasidone vs clozapine in schizophrenia patients refractory to multiple antipsychotic treatments: The MOZART study

Abstract: ErratumErratum to "Ziprasidone vs clozapine in schizophrenia patients refractory to multiple antipsychotic treatments: The MOZART study"

Cited by 37 publications

References 61 publications

The Effects of Novel and Newly Approved Antipsychotics on Serum Prolactin Levels: A Comprehensive Review

The Effects of Novel and Newly Approved Antipsychotics on Serum Prolactin Levels: A Comprehensive Review

Who's left? Symptoms of schizophrenia that predict clinical trial dropout

Evidence review and clinical guidance for the use of ziprasidone in Canada

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