Escitalopram in the Treatment of Dysthymic Disorder, Double Blind

Completed · Phase 4 · Has a placebo group

Conditions studied: Dysthymic Disorder

In brief

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.

Key facts

Study ID

NCT00220701

Run by

St. Luke's-Roosevelt Hospital Center

People needed

36

Starts

2002-06-01

Expected to finish

2009-01-01

Last updated by the study team

2015-11-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Mood Disorders Research Program, St. Luke's-Roosevelt Hospital Center — New York, New York, United States

Full record on ClinicalTrials.gov

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