Escitalopram in the Treatment of Dysthymic Disorder, Double Blind
Condition: Dysthymic Disorder
MeSH terms: Dysthymic Disorder
Intervention: Lexapro (escitalopram)
Intervention description: antidepressant drug selective serotonin reuptake inhibitor (SSRI)
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Dysthymic Disorder; Depression; Chronic Depression; Escitalopram

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.