Escitalopram in the Treatment of Dysthymic Disorder, Double Blind
Dysthymic Disorder
About this trial
This is an interventional treatment trial for Dysthymic Disorder focused on measuring Dysthymic Disorder, Depression, Chronic Depression, Escitalopram
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 2. 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 2. Patients who would pose a serious risk for suicide during the course of the study, as evidenced by one of the following: Report of having a specific plan for killing themselves A score of 3 or higher on the Hamilton Depression Rating Scale item #3 as rated by the treating clinician at Week 0, (indicative of active suicidal thoughts or behaviors) A suicide attempt within the past 12 months requiring emergency room visit, medical or psychiatric hospitalization, or otherwise deemed to be life-threatening (e.g. an overdose of > 1 week's dose of medication. Patients with unstable medical conditions, such as acute hyperthyroidism, uncorrected hypothyroidism, undiagnosed fever, uncontrolled angina, or any other serious medical illness, including any cardiovascular, hepatic, respiratory, hematological, endocrinologic o neurologic disease, or any clinically significant laboratory abnormality. Patients who lack the capacity to proved informed consent 50% or greater decrease in HDRS total score from visit 2 to visit 3 or a CGI-Improvement score of 1 ("very much improved") or 2 ("much improved") at Visit 3 Patients receiving CGI Improvement scores of 6 ("much worse") or 7 ("very much worse") for two consecutive visits will be withdrawn from the study. Patients who meet criteria for Major Depressive Disorder at any time during the course of the study will be withdrawn from the study.
Sites / Locations
- Mood Disorders Research Program, St. Luke's-Roosevelt Hospital Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
escitalopram
Placebo
Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.
inactive comparator