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.
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.