Escitalopram in the Treatment of Dysthymic Disorder, Double Blind

NCT00220701 ↗

Phase 4 Completed 36 enrolled St. Luke's-Roosevelt Hospital Center Forest Laboratories · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a 12-week double-blind placebo-controlled study of Escitalopram in treatment of dysthymic Disorder (low-grade chronic depression), with a 12 week open-label extension phase. It is hypothesized that Escitalopram will be superior to placebo in improving depression, as well as psychosocial, temperamental, and cognitive functioning.

Timeline

Start: 2002-06
Primary completion: 2008-11
Completion: 2009-01

Outcome

Missed primary endpoint

registry Escitalopram vs Placebo; p = 0.10; F statistics 2.82; Repeated Measures ANOVA NCT00220701 ↗

paper Final HDRS-24 scores at last observation carried forward did not differ significantly between escitalopram-treated PMID 21811192 ↗

Publications

Results Hellerstein DJ, Batchelder ST, Hyler S, Arnaout B, Toba C, Benga I, Gangure D. Escitalopram versus placebo in the treatment of dysthymic disorder. Int Clin Psychopharmacol. 2010 May;25(3):143-8. doi: 10.1097/YIC.0b013e328333c35e.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Escitalopram	Small molecule	10 mg	—
Subject	Escitalopram	Small molecule	20 mg	—
Subject	Escitalopram	Small molecule	40 mg	—