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Sponsors and Collaborators: |
St. Luke's-Roosevelt Hospital Center Forest Laboratories |
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Information provided by: | St. Luke's-Roosevelt Hospital Center |
ClinicalTrials.gov Identifier: | NCT00220701 |
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.
Condition | Intervention | Phase |
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Dysthymic Disorder |
Drug: Lexapro (escitalopram) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Double-Blind Placebo-Controlled Study of Escitalopram in the Treatment of Dysthymic Disorder |
Estimated Enrollment: | 40 |
Study Start Date: | June 2002 |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients with a principal diagnosis meeting DSM-IV criteria for:
Patients who would pose a serious risk for suicide during the course of the study, as evidenced by one of the following:
United States, New York | |
Mood Disorders Research Program, St. Luke's-Roosevelt Hospital Center | |
New York, New York, United States, 10019 |
Principal Investigator: | David J. Hellerstein, MD | St. Luke's-Roosevelt Hospital, and NY State Psychiatric Institute |
Study ID Numbers: | LXP-MD-34 |
Study First Received: | September 21, 2005 |
Last Updated: | June 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00220701 History of Changes |
Health Authority: | United States: Institutional Review Board |
Dysthymic Disorder Depression Chronic Depression Escitalopram |
Neurotransmitter Agents Depression Cholinergic Antagonists Psychotropic Drugs Depressive Disorder Cholinergic Agents Serotonin Uptake Inhibitors Citalopram Serotonin |
Muscarinic Antagonists Mental Disorders Mood Disorders Dysthymic Disorder Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Dexetimide Antidepressive Agents |
Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Cholinergic Agents Pathologic Processes Mental Disorders Therapeutic Uses Dexetimide |
Antidepressive Agents, Second-Generation Antidepressive Agents Disease Depressive Disorder Serotonin Uptake Inhibitors Citalopram Pharmacologic Actions Muscarinic Antagonists Serotonin Agents Autonomic Agents Mood Disorders Dysthymic Disorder Peripheral Nervous System Agents Central Nervous System Agents |