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  • Paroxetine in the treatment of dysthymic disorder without co-morbidities: A double-blind, placebo-controlled, flexible-dose study.

Paroxetine in the treatment of dysthymic disorder without co-morbidities: A double-blind, placebo-controlled, flexible-dose study.

Asian journal of psychiatry (2013-03-08)
Arun V Ravindran, Colin Cameron, Raj Bhatla, Lakshmi N Ravindran, Tricia L da Silva
ABSTRACT

Few published studies have evaluated selective serotonin reuptake inhibitors in dysthymia without current co-morbid major depression. In this 12-week study, 40 dysthymic patients were randomly assigned to either placebo (n=19) or 20-40 mg/day of paroxetine (n=21). At endpoint, the paroxetine group showed significantly greater improvement on the Clinical Global Impression Scale, Beck Depression Inventory, and Quality of Life Enjoyment and Satisfaction Questionnaire (p<0.05), and a trend to superiority over placebo on the Hamilton Depression Rating Scale. Response and remission were significantly higher with paroxetine than placebo (p<0.05). There were no significant differences in drop out rates or frequency of adverse effects, except for excessive sweating (greater with paroxetine, p=0.04). Reporting of multiple side effects was also higher with paroxetine than with placebo (p=0.02). Paroxetine is more effective than placebo in improving symptoms and quality of life in dysthymia, and is generally tolerable.

MATERIALS
Product Number
Brand
Product Description

Paroxetine for system suitability, European Pharmacopoeia (EP) Reference Standard
Paroxetine hydrochloride hemihydrate, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
Paroxetine hydrochloride hemihydrate, ≥98% (HPLC), powder
Sigma-Aldrich
Paroxetine maleate salt, ≥98% (HPLC), solid
Supelco
Paroxetine maleate solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material, Cerilliant®