Escitalopram in the Treatment of Dysthymic Disorder, Double Blind

Condition(s) targeted: Dysthymic Disorder

Intervention: Lexapro (escitalopram) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: St. Luke's-Roosevelt Hospital Center

Official(s) and/or principal investigator(s):
David J. Hellerstein, MD, Principal Investigator, Affiliation: St. Luke's-Roosevelt Hospital, and NY State Psychiatric Institute

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.

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome:

Hamilton-Depression Rating Scale (HDRS-24 items)

Cornell Dysthymia Rating Scale (CDRS)

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)

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 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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male and female outpatients 18-65 years of age.

- Patients with a 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.

Mood Disorders Research Program, St. Luke's-Roosevelt Hospital Center, New York, New York 10019, United States

For more information about our program and this study click here.

Starting date: June 2002
Last updated: June 5, 2007