Clinical Trial: Escitalopram in the Treatment of Dysthymic Disorder, Double Blind

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Double-Blind Placebo-Controlled Study of Escitalopram in the Treatment of Dysthymic Disorder

Brief Summary:

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.


Detailed Summary:

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.


Sponsor: St. Luke's-Roosevelt Hospital Center

Current Primary Outcome:

  • Hamilton-Depression Rating Scale (HDRS-24 Items) [ Time Frame: Week 12 ]
    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 ]
    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)


Original Primary Outcome:

  • Hamilton-Depression Rating Scale (HDRS-24 Items)
  • Cornell Dysthymia Rating Scale (CDRS)


Current Secondary Outcome:

  • Clinical Global Impressions - Severity (CGI-S) [ Time Frame: Week 12 ]
    Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)
  • Beck Depression Inventory (BDI) [ Time Frame: Baseline ]
    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 ]
    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 ]
    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.


Original Secondary Outcome:

  • 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)


Information By: St. Luke's-Roosevelt Hospital Center

Dates:
Date Received: September 21, 2005
Date Started: June 2002
Date Completion:
Last Updated: October 13, 2015
Last Verified: November 2007