Status:
COMPLETED
Escitalopram in the Treatment of Dysthymic Disorder, Double Blind
Lead Sponsor:
St. Luke's-Roosevelt Hospital Center
Collaborating Sponsors:
Forest Laboratories
Conditions:
Dysthymic Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 hypothesize...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00220701
Start Date
June 1 2002
End Date
January 1 2009
Last Update
November 11 2015
Active Locations (1)
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1
Mood Disorders Research Program, St. Luke's-Roosevelt Hospital Center
New York, New York, United States, 10019