Escitalopram in the Treatment of Dysthymic Disorder, Double Blind
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.
Description
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.
Flexible dosing to a maximum of 40 mg per day will be used. It is hypothesized that Escitalopram will be superior to placebo in improving depression, as well as psychosocial, temperamental, and cognitive functioning. Blood cytokine levels will also be measured at weeks 0, 12, and 24 to determine their relationship to depressive symptoms and improvement.
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Dysthymic Disorder
Intervention
Lexapro (escitalopram)
Location
Mood Disorders Research Program, St. Luke's-Roosevelt Hospital Center
New York
New York
United States
10019
Status
Completed
Source
St. Luke's-Roosevelt Hospital Center
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00220701
- Information obtained from ClinicalTrials.gov on July 04, 2012
Medical and Biotech [MESH] Definitions
Isocarboxazid
An MAO inhibitor that is effective in the treatment of major depression, dysthymic disorder, and atypical depression. It also is useful in the treatment of panic disorder and the phobic disorders. (From AMA, Drug Evaluations Annual, 1994, p311)
Tranylcypromine
A propylamine formed from the cyclization of the side chain of amphetamine. This monoamine oxidase inhibitor is effective in the treatment of major depression, dysthymic disorder, and atypical depression. It also is useful in panic and phobic disorders. (From AMA Drug Evaluations Annual, 1994, p311)
Dysthymic Disorder
Chronically depressed mood that occurs for most of the day more days than not for at least 2 years. The required minimum duration in children to make this diagnosis is 1 year. During periods of depressed mood, at least 2 of the following additional symptoms are present: poor appetite or overeating, insomnia or hypersomnia, low energy or fatigue, low self esteem, poor concentration or difficulty making decisions, and feelings of hopelessness. (DSM-IV)
Conversion Disorder
A disorder whose predominant feature is a loss or alteration in physical functioning that suggests a physical disorder but that is actually a direct expression of a psychological conflict or need.
Antisocial Personality Disorder
A personality disorder whose essential feature is a pervasive pattern of disregard for, and violation of, the rights of others that begins in childhood or early adolescence and continues into adulthood. The individual must be at least age 18 and must have a history of some symptoms of CONDUCT DISORDER before age 15. (From DSM-IV, 1994)
Clinical Trials
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The purpose of the study is to evaluate the efficacy and safety of flexible doses of escitalopram (Lexapro) compared to sertraline (Zoloft) for treatment of Dysthymic Disorder.
Pilot Study to Evaluate Escitalopram in Obsessive-Compulsive Disorder
This study will determine the safety and effectiveness of escitalopram (Lexapro)in treating obsessive-compulsive disorder (OCD) symptoms.
Food Study of Escitalopram Oxalate Tablets 20 mg to Lexapro® Tablets 20 mg
The objective of this study was to investigate the bioequivalence of Mylan's escitalopram oxalate 20 mg tablets to Forest's Lexapro® 20 mg tablets following a single, oral 20 mg (1 x 20 m...
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The purpose of this study is to determine the safety and efficacy of escitalopram (Lexapro) using 10 or 20 mg daily in patients with Alzheimer’s disease who are also experiencing agitati...
Wellbutrin XL for Dysthymic Disorder
This is a ten-week, double-blind study of Wellbutrin XL in outpatients with dysthymic disorder, a form of low-grade chronic depression. We hypothesize that patients taking Wellbutrin XL w...
PubMed Articles
Escitalopram: a review of its use in the management of major depressive disorder in adults.
Escitalopram (escitalopram oxalate; Cipralex(R), Lexapro(R)), a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder (MDD), demonstrates a highly sele...
The aim of this proof-of-concept study was to compare the efficacy of escitalopram (20 mg/d) in combination with fixed doses of gaboxadol to escitalopram (20 mg) in the treatment of patients with seve...
It has been suggested that antidepressants, including the selective serotonin reuptake inhibitors have neurotrophic effects. Nevertheless, the impact of treatment with a selective serotonin re-uptake...
Despite the clinical prevalence of the antidepressant escitalopram, over 30% of escitalopram-treated patients fail to respond to treatment. Recent gene association studies have highlighted a potential...
The aim of this study was to determine whether the serotonin transporter gene polymorphism (5-HTTLPR) is associated with the treatment outcomes of escitalopram for patients with comorbid major depress...
