P01-114 A randomized and double- blind clinical trial of venlafaxine hydrochloride sustained release capsules for treating juvenile depression

Abstract

Object:To evaluate the efficacy and safety of venlafaxine hydrochloride(HCL) sustained release capsules in treating juvenile with depressive disorder.Methods:A randomized, double blind dummy clinical trial enrolled 60 adolescent patients with depression, who were randomizedly designed to administer venlafaxine HCL sustained release capsules 150 mg or fluoxetine 20 mg daily for 8 weeks. The efficacies of both treatment groups was evaluated based on the Hamilton Depression Scale and Clinical General impression Scale pre and post-treatment.Results:The scores of Hamilton Depression Scale at the end of therapy were significantly reduced compared with the baseline in both gtnups (P< 0.O1). The effective rate of venlafaxine HCL sustained release capsules versus fluoxetine treatmlent was 70.0% and 65.5%, respectively, the P value showed no statistical difference (P>0. OS). The common adverse reactions included dry mouth, insomnia, dizziness, and loss of appetite.Conclusion:Venlafaxine HCl sustained release capsules is an effective agent for juvenile with major depression.