Efficacy and safety of low dosage risperidone added on valproate and citalopram in the treatment of acute bipolar depression

doi:10.3969/j.issn.1006-7795.2014.02.013

Abstract

Abstract: Objective To evaluate the augmentation efficacy and safety of low dosage risperidone, added on the usual treatment(valproate and citalopram) in the acute treatment of bipolar depression. Methods A total of 46 inpatients with a diagnostic criteria for acute depression episode with bipolar disorder according to DSM-IV-TR were first given valproate and citalopram treatment. The subjects who achieve little clinical response(i.e. reduction from baseline in total MADRS score by <50%) at the end of 2-week will enter into the randomized open-label 6-week treatment phase. The eligible subjects will be randomized to treatment with valproate & citalopram or valproate & citalopram & risperidone in a 1:1 ratio. Efficacy rating scales to be used in the study include MADRS, YMRS, BPRS(total score and positive subscale), CGI-S, and CGI-I. The evaluations of safety and tolerability include SAS, treatment-emergent mania, clinical laboratory tests, vital signs, ECG, and adverse events reports. Results At the end of treatment, the scores of MADRS, BPRS, GIC-I, and CGI-S in both treatment groups decreased significantly compared with the end of run-in period.There were statistically significant differences between groups in YMRS and CGI-I(P<0.05), but not in MADRS and BPRS(total score and positive subscale). At week 1 of randomized treatment period, the scores of BPRS positive subscale decreased sharply in the VPA+CIT+RIS group than those in the VPA+CIT group, the difference was statistically significant(P<0.05). At week 2 of randomized treatment period, the response rates of the VPA+CIT+RIS group was superior to the VPA+CIT group, the difference was statistically significant(P<0.05). It suggested that the time to response of the VPA+CIT+RIS group is shorter than that of the VPA+CIT group. Conclusion Both VPA+CIT+RIS and VPA+CIT are efficacious and well tolerated for the acute treatment of bipolar depression. For the treatment of psychosis and reducing the treatment-emergent mania, the VPA+CIT group was better than the VPA+CIT group.

Key words: resperidone, augmentation treatment, bipolar disorder, acute depressive episode

CLC Number:

R749.4

Wang Jian, Wang Gang, Ma Xin. Efficacy and safety of low dosage risperidone added on valproate and citalopram in the treatment of acute bipolar depression[J]. Journal of Capital Medical University, 2014, 35(2): 205-209.

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URL: https://journal03.magtech.org.cn/Jweb_sdykdxxb/EN/10.3969/j.issn.1006-7795.2014.02.013

https://journal03.magtech.org.cn/Jweb_sdykdxxb/EN/Y2014/V35/I2/205

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