Phase 4
N=34
Escitalopram in the Treatment of Dysthymic Disorder, Double Blind
Dysthymic Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00220701 ↗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
| Outcome | Result | p-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.
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.