Double-Blind Placebo-Controlled Study of Escitalopram in the Treatment of Dysthymic Disorder
Overview
- Phase
- Phase 4
- Intervention
- Lexapro (escitalopram)
- Conditions
- Dysthymic Disorder
- Sponsor
- St. Luke's-Roosevelt Hospital Center
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Hamilton-Depression Rating Scale (HDRS-24 Items)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female outpatients 18-65 years of age.
- •Patients with a Diagnostic and Statistical Manual, fourth edition (DSM-IV) diagnosis of dysthymic disorder.
- •Subject must be considered reliable.
- •Patients will have a total of 12 or higher on the Hamilton Depression Scale (24 items) at baseline.
Exclusion Criteria
- •Patients with a DSM-IV diagnosis of Delirium, Dementia, and Amnestic, and other Cognitive Disorders.
- •Patients who plan to produce a pregnancy within the next 6 months, or patients who are pregnant or nursing women.
- •Patients who have a history of non-response to two or more sufficient trials of antidepressant medication (as defined in Table 1).
- •Patients with a principal diagnosis meeting DSM-IV criteria for:
- •Major Depressive Disorder, current
- •Bipolar Disorder or cyclothymia .Schizophrenia, Delusional (Paranoid) Disorders and Psychotic Disorders not elsewhere classified.
- •Anorexia Nervosa or Bulimia
- •Patients who, within the past 6 months, met DSM-IV criteria for abuse of or dependence on any drug, including alcohol, excluding caffeine and tobacco.
- •Patients who have taken psychotropic medication or herbal preparations with putative psychotropic effects within 7 days prior to Visit
- •Patients taking a monoamine oxidase inhibitor (a type of antidepressant) (MAOI) must have a washout period of 14 days prior to visit 2, and patients taking fluoxetine must have a washout period of at least 4 weeks prior to Visit
Arms & Interventions
escitalopram
Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.
Intervention: Lexapro (escitalopram)
Placebo
inactive comparator
Intervention: Lexapro (escitalopram)
Outcomes
Primary Outcomes
Hamilton-Depression Rating Scale (HDRS-24 Items)
Time Frame: Baseline
Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (\>50% decrease) Remission (score\<=7)
Secondary Outcomes
- Beck Depression Inventory (BDI)(Week 12)
- Clinical Global Impressions - Severity (CGI-S)(Baseline)