Abstract：
BACKGROUND:Selective localization of dopamine D(4) receptors in the prefrontal cortex and preferential affinity of clozapine for the dopamine D(4) receptor over the D(2) receptor led to the hypothesis that the superior efficacy of clozapine may be mediated via blockade of the D(4) receptor. This hypothesis was tested by evaluating sonepiprazole, a selective D(4) dopamine antagonist, in schizophrenia patients. METHODS:We treated 467 hospitalized schizophrenia patients with scores of > or = 60 on the Positive and Negative Syndrome Scale (PANSS) with sonepiprazole, olanzapine, or placebo once daily for 6 weeks. The primary efficacy end point was the mean change from baseline in the PANSS total score at 6 weeks. Secondary efficacy end points were the mean change from baseline in the PANSS factor scores, the Brief Psychiatric Rating Scale score, the Clinical Global Impressions Severity of Illness score, and the Calgary Depression Scale score. RESULTS:No statistically significant differences were observed between placebo and any sonepiprazole dose on the primary or any secondary end point after 6 weeks of treatment. Statistically significant differences, favoring olanzapine over placebo, were observed on all efficacy end points but the Calgary Depression Scale. CONCLUSIONS:Sonepiprazole was ineffective for the treatment of patients with schizophrenia.
journal_name
Biol Psychiatryjournal_title
Biological psychiatryauthors
Corrigan MH,Gallen CC,Bonura ML,Merchant KM,Sonepiprazole Study Group.doi
10.1016/j.biopsych.2003.10.004subject
Has Abstractpub_date
2004-03-01 00:00:00pages
445-51issue
5eissn
0006-3223issn
1873-2402pii
S000632230301076Xjournal_volume
55pub_type
临床试验,杂志文章,多中心研究,随机对照试验abstract：:The recent deliberations by the U.S. Food and Drug Administration (FDA) regarding the relationship between antidepressants and suicidality in children have incited debates about the safety of these medications for the treatment of pediatric depression. In light of these events, this review discusses four issues pertai...
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