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Escitalopram in the Treatment of Dysthymic Disorder, Double Blind
This study has been completed.
Sponsors and Collaborators: St. Luke's-Roosevelt Hospital Center
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

MedlinePlus related topics: Depression
Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate
U.S. FDA Resources
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

Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:
  • Hamilton-Depression Rating Scale (HDRS-24 items) [ Time Frame: 12 weeks ]
  • Cornell Dysthymia Rating Scale (CDRS) [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Clinical Global Impressions – Severity (CGI-S) [ Time Frame: 12 weeks ]
  • Clinical Global Impressions – Improvement (CGI-I) [ Time Frame: 12 weeks ]
  • Global Assessment of Functioning Scale (GAFS) [ Time Frame: 12 weeks ]
  • Symptom Checklist (SCL-90-R) [ Time Frame: 12 weeks ]
  • Beck Depression Inventory (BDI) [ Time Frame: 12 weeks ]
  • Patient-CGI (CGI-P) [ Time Frame: 12 weeks ]
  • Social Adjustment Scale (SAS) [ Time Frame: 12 weeks ]
  • Temperament and Character Inventory (TCI) [ Time Frame: 12 weeks ]
  • Medical Outcomes Trust Cognitive Scale (MOTCS) [ Time Frame: 12 weeks ]
  • AB Neuropsychological Assessment Scale (ABS) [ Time Frame: 12 weeks ]

Estimated Enrollment: 40
Study Start Date: June 2002
Detailed Description:

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
Criteria

Inclusion Criteria:

  • Male and female outpatients 18-65 years of age.
  • Patients with a 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00220701

Locations
United States, New York
Mood Disorders Research Program, St. Luke's-Roosevelt Hospital Center
New York, New York, United States, 10019
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
Forest Laboratories
Investigators
Principal Investigator: David J. Hellerstein, MD St. Luke's-Roosevelt Hospital, and NY State Psychiatric Institute
  More Information

Additional Information:
No publications provided

Study ID Numbers: LXP-MD-34
Study First Received: September 21, 2005
Last Updated: June 5, 2007
ClinicalTrials.gov Identifier: NCT00220701  
Health Authority: United States: Institutional Review Board

Keywords provided by St. Luke's-Roosevelt Hospital Center:
Dysthymic Disorder
Depression
Chronic Depression
Escitalopram

Study placed in the following topic categories:
Depression
Mental Disorders
Mood Disorders
Dysthymic Disorder
Dexetimide
Depressive Disorder
Citalopram
Serotonin

Additional relevant MeSH terms:
Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on February 12, 2009