Double-blind comparison of ziprasidone and risperidone in the treatment of Chinese patients with acute exacerbation of schizophrenia

Abstract

Background:The aim of the study was to evaluate the efficacy and safety of ziprasidone versus risperidone in Chinese subjects with acute exacerbation of schizophrenia.Methods:In patients meeting the Chinese Classification of Mental Disorders criteria for schizophrenia and with a Positive and Negative Syndrome Scale (PANSS) total score ≥60 were randomly assigned to six weeks of double-blind treatment with ziprasidone 40–80 mg twice daily or risperidone 1–3 mg bid, flexibly dosed. Noninferiority was demonstrated if the upper limit of the two-sided 95% confidence interval (CI) for the difference in PANSS total score improvement from baseline in the evaluable population was smaller than the prespecified noninferiority margin of 10 units.Results:The intent-to-treat population comprised 118 ziprasidone-treated and 121 risperidone-treated subjects. Improvement (reduction) from baseline to week 6 in PANSS total score was (−35.6 [95% CI: −38.6, −32.6]) for ziprasidone and (−37.1 [95% CI: −39.9, −34.4]) for risperidone. Noninferiority was demonstrated in the evaluable population with a difference score of 1.5 [95% CI: −2.5, 5.5]. Mean prolactin levels decreased at week 6 compared with baseline for ziprasidone (−3.5 ng/mL), but significantly increased for risperidone (61.1 ng/mL; P < 0.001). More risperidone-treated subjects (14.9%) than ziprasidone-treated subjects (4.2%) reported weight gain ≥7%. Akathisia and somnolence in the ziprasidone group and akathisia and insomnia in the risperidone group were the most common side effects. Treatment-related/treatment-emergent adverse events were reported by 79.7% and 71.1% of ziprasidone-treated and risperidone-treated subjects, respectively.Conclusion:In Chinese subjects, ziprasidone was as effective as risperidone, with less weight gain and less prolactin elevation.

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

“…When data are reported in a categorical manner, there is evidence that almost all subjects (72–100 %) receiving oral risperidone [ 66 , 74 , 87 , 101 , 108 , 243 , 301 ] and many subjects (53–85 %) receiving risperidone long-acting intramuscular injection have HPRL [ 66 , 172 , 243 ]. The largest randomized controlled trial ( n = 555) reporting PRL data found an incidence of 73.8 % (>18 ng/ml in men, >25 ng/ml in women) in risperidone-treated subjects with first-episode psychosis [ 101 ].…”

“…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.…”

Weight gain and antipsychotics: a drug safety review

“…There is a lack of highquality and large-sample-size studies of clozapine in recent years in all diagnostic groups. [190] Double-blind 38.5 [191] Double-blind [192] Double-blind [193] Double A prior study by Zipursky et al comparing weight gain dynamics from haloperidol and olanzapine (n = 263) in patients with first-episode psychosis, which is worth mentioning, showed a rapid weight increase within the first 12 weeks and a relatively stabilised situation thereafter. In the haloperidol group people gained 3.7 kg after 12 weeks, 7.1 kg after 1 year and 7.5 kg after 2 years.…”

Efficacy and acceptability of three prolactin-sparing antipsychotics in patient with schizophrenia: a network meta-analysis

“…Most reports have indicated that ziprasidone use is associated with a low incidence of prolactin elevation and low to moderate levels of hyperprolactinemia [57,58,61,80,81]. Some studies revealed that treatment with ziprasidone leads to decreased prolactin levels for six weeks [82], 4-8 weeks [83], 18 weeks [84], 44 weeks [85] and one year [86], respectively. However, few trials also reported that ziprasidone induced hyperprolactinemia [87][88][89][90][91][92].…”