At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 36 enrolled
Drug / intervention
Lexapro (escitalopram)drug
Likely dose
Not stated in record
Key inclusion· 3
- ✓Age 18–65 years, male or female outpatients
- ✓DSM-IV diagnosis of dysthymic disorder
- ✓Hamilton Depression Scale (24-item) total score ≥12 at baseline
Key exclusion· 9
- ✕DSM-IV diagnosis of delirium, dementia, amnestic, or other cognitive disorders
- ✕Current Major Depressive Disorder, Bipolar Disorder, cyclothymia, schizophrenia, delusional or psychotic disorders
- ✕Anorexia Nervosa or Bulimia Nervosa
- ✕Substance abuse or dependence within past 6 months (excluding caffeine and tobacco)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Double-Blind Placebo-Controlled Study of Escitalopram in the Treatment of Dysthymic Disorder
In Brief
A Phase 4 clinical trial evaluating Lexapro (escitalopram) for Dysthymic Disorder. Completed, enrolled 36 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDysthymic Disorder
CountriesUnited States
CollaboratorsForest Laboratories
Timeline
Phase 4CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2002
First PostedSep 2005
Primary CompletionNov 2008
Study CompletionJan 2009
TodayJul 2026
First PostedSep 22, 2005
Enrollment StartJun 1, 2002
Primary CompletionNov 1, 2008
Study CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 20.8 years ago
Interventions
Lexapro (escitalopram)drug
antidepressant drug selective serotonin reuptake inhibitor (SSRI)