Escitalopram in the Treatment of Dysthymic Disorder, Double Blind

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT00220701
First received: September 21, 2005
Last updated: June 6, 2012
Last verified: June 2007
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-Blind Placebo-Controlled Study of Escitalopram in the Treatment of Dysthymic Disorder

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    clinician rated depression symptoms


Secondary Outcome Measures:
  • Clinical Global Impressions - Severity (CGI-S) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    clinician rated severity

  • Clinical Global Impressions - Improvement (CGI-I) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    clinician rated improvement

  • Beck Depression Inventory (BDI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    patient rated depression symptoms


Enrollment: 36
Study Start Date: June 2002
Study Completion Date: January 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: escitalopram
antidepressant medication
Drug: Lexapro (escitalopram)
antidepressant drug SSRI
Other Names:
  • lexapro
  • escitalopram
  • s-citalopram
  • d-citalopram
Placebo Comparator: Placebo
inactive comparator
Drug: Lexapro (escitalopram)
antidepressant drug SSRI
Other Names:
  • lexapro
  • escitalopram
  • s-citalopram
  • d-citalopram

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Publications:
Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT00220701     History of Changes
Other Study ID Numbers: LXP-MD-34
Study First Received: September 21, 2005
Last Updated: June 6, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Dysthymic Disorder
Depressive Disorder
Mood Disorders
Mental Disorders
Antidepressive Agents
Citalopram
Dexetimide
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on July 31, 2014