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.
aMental Health Institute of the Second Xiangya Hospital, Central South University, Changsha
bMental Health Center, Tonggi Medical College of Huazhong University of Science and Technology, Wuhan
cShanghai Mental Health Center, Shanghai
dBeijing Anding Hospital, Capital Medical University, Beijing
eGuangzhou Brain Hospital, Guangzhou
fChongqing Mental Health Center, Chongqing, Peoples’s Republic of China
Maosheng Fang and Honghui Chen contributed equally to this study.
Correspondence to Jing-Ping Zhao, Mental Health Institute of the Second Xiangya Hospital, Central South University, 139 Renmin Middle Road, Changsha 410011, Hunan, Peoples’s Republic of China Tel: +86 138 084 657 28; fax: +86 731 536 0921; e-mail: firstname.lastname@example.org
Received September 21, 2011
Accepted November 28, 2011