title: Comparison of risperidone oral solution and intramuscular haloperidol with the latter shifting to oral therapy for the treatment of acute agitation in patients with schizophrenia.
abstract: This randomized, parallel-group, open study investigated the efficacy and safety of risperidone oral solution (RIS-OS) in combination with clonazepam and intramuscular haloperidol for the treatment of acute agitation in patients with schizophrenia, and the study explored the possibility of decreasing the efficacy of an acute 6-week treatment by switching intramuscular haloperidol injection to RIS-OS. Two hundred and five agitation-exhibiting schizophrenic inpatients at six hospitals were originally included in the study. The 47-day trial consisted of 5 days (session I) of receiving either oral treatment (RIS-OS plus clonazepam) or intramuscular treatment (intramuscular haloperidol) and a 42-day (session II) period of either withdrawing from clonazepam or shifting from intramuscular haloperidol to a RIS-OS period. The primary efficacy outcome was measured as the change in the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) in session I and the change in the PANSS in session II. Safety was assessed by the frequency of the adverse events. Mean PANSS-EC improvement was significant after 5 days of treatment in both groups (P>0.05) and was similar between the two treatment groups (P<0.01). Most patients' PANSS-EC scores improved or remained stable during the drawback/shift treatment period. Efficacy was not significantly different between the two treatment groups after the 6-week treatment (P>0.05). However, combination treatment exhibited greater efficacy, and adverse events, especially extrapyramidal symptoms, were lower with the oral treatment than with the intramuscular treatment in session I. These results show that RIS-OS in combination with clonazepam is an effective treatment, comparable with intramuscular haloperidol, and is well-tolerated for acute agitation in patients with schizophrenia.
authors.affiliation: Mental Health Institute of the Second Xiangya Hospital, Central South University, Changsha, Peoples's Republic of China.
authors.forename: Maosheng
authors.initials: M
authors.lastname: Fang
authors.forename: Honghui
authors.initials: H
authors.lastname: Chen
authors.forename: Le-Hua
authors.initials: LH
authors.lastname: Li
authors.forename: Renrong
authors.initials: R
authors.lastname: Wu
authors.forename: Yi
authors.initials: Y
authors.lastname: Li
authors.forename: Lianzhong
authors.initials: L
authors.lastname: Liu
authors.forename: Meng
authors.initials: M
authors.lastname: Ye
authors.forename: Jizhong
authors.initials: J
authors.lastname: Huang
authors.forename: Suoyu
authors.initials: S
authors.lastname: Zhu
authors.forename: Gang
authors.initials: G
authors.lastname: Wang
authors.forename: Qinge
authors.initials: Q
authors.lastname: Zhang
authors.forename: Hongbo
authors.initials: H
authors.lastname: Zheng
authors.forename: Lulu
authors.initials: L
authors.lastname: Zhang
authors.forename: Bo
authors.initials: B
authors.lastname: Wang
authors.forename: Jianchu
authors.initials: J
authors.lastname: Zhou
authors.forename: Jing-Ping
authors.initials: JP
authors.lastname: Zhao
mesh_terms: D000284:Administration, Oral; D000328:Adult; D017109:Akathisia, Drug-Induced / Q000517:prevention & control; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002681:China; D002998:Clonazepam / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D039721:Diagnostic and Statistical Manual of Mental Disorders; D016903:Drug Monitoring; D004359:Drug Therapy, Combination / Q000009:adverse effects; D005260:Female; D006220:Haloperidol / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D007273:Injections, Intramuscular; D008297:Male; D011595:Psychomotor Agitation / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D018967:Risperidone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012559:Schizophrenia / Q000503:physiopathology*; D012720:Severity of Illness Index; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D006993:Hypnotics and Sedatives; D002998:Clonazepam; D006220:Haloperidol; D018967:Risperidone