Dysthymic Disorder: Double-Blind Placebo-Controlled Study of Escitalopram in the Treatment of Dysthymic Disorder

Contact name: Sarai Batchelder, PhD

Phone: (212)-523-7666

Fax: (212)-523-7635

Email: sbatchel@chpnet.org

Disorder: Dysthymic Disorder (chronic mild depression)

Geographic location: New York City

Other keywords: dysthymia, chronic depression,

Participant compensation: reimbursement for travel expenses

Time commitment required: 45 minute visits, 10-14 visits over 24 weeks

Drug trial: Yes

Recruitment end date (approximate): April 21, 2006

Study criteria (i.e., age or gender requirements):
1. Male and female outpatients 18-65 years of age.
2. Patients with a DSM-IV diagnosis of dysthymic disorder, involving depressed or down or low mood for at least two years, or longer.

Exclusion criteria:
1. Patients with a DSM-IV diagnosis of Delirium, Dementia, and Amnestic, and other Cognitive Disorders.
2. Patients who intend to produce a pregnancy within 4 months, or who are currently pregnant or nursing women
3. Patients who have a history of non-response to two or more sufficient courses of antidepressant medication (defined as 6 weeks of the equivalent of 20 mg. fluoxetine).
4. 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
5. 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.
6. Patients who have taken psychotropic medication within 7 days prior to visit 2. Patients taking monoamine oxidase inhibitors (MAOIs) must have a washout period of at least 14 days prior to visit 2, and patients taking fluoxetine (Prozac) must have a washout period of at least 28 days prior to visit 2.
7. Patients who would pose a serious risk for suicide during the course of the study or who have made a serious suicide attempt within the past 6 months
8. 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 or neurologic disease

Brief description of study:
This is a 12-week double-blind placebo-controlled study of Lexapro (escitalopram) in treatment of chronic mild depression, with a 12 week open-label (no placebo) followup.

Additional information:
This study is also analysing blood levels of chemicals called cytokines before and after treatment. Elevated cytokine levels are thought to induce some changes seen in medical illness and depression related to sickness behavior (which may include depressed mood, weight loss, insomnia, and impaired concentration).