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Escitalopram in the Treatment of Dysthymic Disorder, Double Blind

Primary Purpose

Dysthymic Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lexapro (escitalopram)
Sponsored by
St. Luke's-Roosevelt Hospital Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysthymic Disorder focused on measuring Dysthymic Disorder, Depression, Chronic Depression, Escitalopram

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mood Disorders Research Program, St. Luke's-Roosevelt Hospital Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

escitalopram

Placebo

Arm Description

Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.

inactive comparator

Outcomes

Primary Outcome Measures

Hamilton-Depression Rating Scale (HDRS-24 Items)
Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7)
Hamilton-Depression Rating Scale (HDRS-24 Items)
Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7)

Secondary Outcome Measures

Clinical Global Impressions - Severity (CGI-S)
Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)
Beck Depression Inventory (BDI)
21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.
Clinical Global Impressions - Severity (CGI-S)
Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)
Beck Depression Inventory (BDI)
21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.

Full Information

First Posted
September 21, 2005
Last Updated
October 13, 2015
Sponsor
St. Luke's-Roosevelt Hospital Center
Collaborators
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00220701
Brief Title
Escitalopram in the Treatment of Dysthymic Disorder, Double Blind
Official Title
Double-Blind Placebo-Controlled Study of Escitalopram in the Treatment of Dysthymic Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Luke's-Roosevelt Hospital Center
Collaborators
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 hypothesized that Escitalopram will be superior to placebo in improving depression, as well as psychosocial, temperamental, and cognitive functioning.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysthymic Disorder
Keywords
Dysthymic Disorder, Depression, Chronic Depression, Escitalopram

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
escitalopram
Arm Type
Experimental
Arm Description
Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
inactive comparator
Intervention Type
Drug
Intervention Name(s)
Lexapro (escitalopram)
Other Intervention Name(s)
lexapro, escitalopram, s-citalopram, d-citalopram
Intervention Description
antidepressant drug selective serotonin reuptake inhibitor (SSRI)
Primary Outcome Measure Information:
Title
Hamilton-Depression Rating Scale (HDRS-24 Items)
Description
Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7)
Time Frame
Week 12
Title
Hamilton-Depression Rating Scale (HDRS-24 Items)
Description
Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7)
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Clinical Global Impressions - Severity (CGI-S)
Description
Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)
Time Frame
Week 12
Title
Beck Depression Inventory (BDI)
Description
21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.
Time Frame
Baseline
Title
Clinical Global Impressions - Severity (CGI-S)
Description
Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)
Time Frame
Baseline
Title
Beck Depression Inventory (BDI)
Description
21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J. Hellerstein, MD
Organizational Affiliation
St. Luke's-Roosevelt Hospital, and NY State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mood Disorders Research Program, St. Luke's-Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21811192
Citation
Hellerstein DJ, Batchelder ST, Hyler S, Arnaout B, Toba C, Benga I, Gangure D. Escitalopram versus placebo in the treatment of dysthymic disorder. Int Clin Psychopharmacol. 2010 May;25(3):143-8. doi: 10.1097/YIC.0b013e328333c35e.
Results Reference
result
Links:
URL
http://www.DepressionNY.com
Description
For more information about our program and this study click here.

Learn more about this trial

Escitalopram in the Treatment of Dysthymic Disorder, Double Blind

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