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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: November 19, 2014
Last verified: November 2007

September 21, 2005
November 19, 2014
June 2002
November 2008   (final data collection date for primary outcome measure)
  • Hamilton-Depression Rating Scale (HDRS-24 Items) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7)
  • Hamilton-Depression Rating Scale (HDRS-24 Items) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7)
  • Hamilton-Depression Rating Scale (HDRS-24 items)
  • Cornell Dysthymia Rating Scale (CDRS)
Complete list of historical versions of study NCT00220701 on ClinicalTrials.gov Archive Site
  • Clinical Global Impressions - Severity (CGI-S) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)
  • Clinical Global Impressions - Improvement (CGI-I) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    clinician rated improvement, score on CGI scale ranging from 1 (very much improved) to 7 (very much worse)
  • Beck Depression Inventory (BDI) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.
  • Clinical Global Impressions - Severity (CGI-S) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)
  • Beck Depression Inventory (BDI) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.
  • Clinical Global Impressions – Severity (CGI-S)
  • Clinical Global Impressions – Improvement (CGI-I)
  • Global Assessment of Functioning Scale (GAFS)
  • Symptom Checklist (SCL-90-R)
  • Beck Depression Inventory (BDI)
  • Patient-CGI (CGI-P)
  • Social Adjustment Scale (SAS)
  • Temperament and Character Inventory (TCI)
  • Medical Outcomes Trust Cognitive Scale (MOTCS)
  • AB Neuropsychological Assessment Scale (ABS)
Not Provided
Not Provided
 
Escitalopram in the Treatment of Dysthymic Disorder, Double Blind
Double-Blind Placebo-Controlled Study of Escitalopram in the Treatment of Dysthymic Disorder

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Dysthymic Disorder
Drug: Lexapro (escitalopram)
antidepressant drug selective serotonin reuptake inhibitor (SSRI)
Other Names:
  • lexapro
  • escitalopram
  • s-citalopram
  • d-citalopram
  • Experimental: escitalopram
    Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.
    Intervention: Drug: Lexapro (escitalopram)
  • Placebo Comparator: Placebo
    inactive comparator
    Intervention: Drug: Lexapro (escitalopram)
Hellerstein DJ, Batchelder ST, Hyler S, Arnaout B, Toba C, Benga I, Gangure D. Escitalopram versus placebo in the treatment of dysthymic disorder. Int Clin Psychopharmacol. 2010 May;25(3):143-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
January 2009
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00220701
LXP-MD-34
No
St. Luke's-Roosevelt Hospital Center
St. Luke's-Roosevelt Hospital Center
Forest Laboratories
Principal Investigator: David J. Hellerstein, MD St. Luke's-Roosevelt Hospital, and NY State Psychiatric Institute
St. Luke's-Roosevelt Hospital Center
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP