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Phase 4 N=34 Randomized Quadruple-blind Treatment

Escitalopram in the Treatment of Dysthymic Disorder, Double Blind

Dysthymic Disorder

Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Hamilton-Depression Rating Scale (HDRS-24 Items) — 10.88; 16.41 units on a scale — p=0.10

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Lexapro (escitalopram) (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
St. Luke's-Roosevelt Hospital Center
Primary completion
Nov 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Hamilton-Depression Rating Scale (HDRS-24 Items)
22.82; 24.41
PRIMARY
Hamilton-Depression Rating Scale (HDRS-24 Items)
22.82; 24.41
SECONDARY
Clinical Global Impressions - Severity (CGI-S)
4.06; 4.06
SECONDARY
Beck Depression Inventory (BDI)
6.76; 10.00
SECONDARY
Clinical Global Impressions - Severity (CGI-S)
4.06; 4.06
SECONDARY
Beck Depression Inventory (BDI)
6.76; 10.00

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.

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00220701). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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