|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | St. Luke's-Roosevelt Hospital Center |
|---|---|
| Collaborator: |
Forest Laboratories |
| Information provided by: | St. Luke's-Roosevelt Hospital Center |
| ClinicalTrials.gov Identifier: | NCT00220701 |
Purpose
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 |
|---|---|---|
|
Dysthymic Disorder |
Drug: Lexapro (escitalopram) |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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.
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| ClinicalTrials.gov Identifier: | NCT00220701 History of Changes |
| Other Study ID Numbers: | LXP-MD-34 |
| Study First Received: | September 21, 2005 |
| Last Updated: | June 5, 2007 |
| Health Authority: | United States: Institutional Review Board |
|
Dysthymic Disorder Depression Chronic Depression Escitalopram |
|
Dysthymic Disorder Depressive Disorder Mood Disorders Mental Disorders Dexetimide Citalopram Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Parasympatholytics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Serotonin Agents |