Escitalopram in the Treatment of Dysthymic Disorder, Double Blind

Dysthymic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00220701
• Other study ID #: LXP-MD-34
• Status: Completed
• Phase: Phase 4
• First received: September 21, 2005
• Last updated: October 13, 2015
• Start date: June 2002
• Est. completion date: January 2009

Study information

• Verified date: November 2007
• Source: St. Luke's-Roosevelt Hospital Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysthymic Disorder

Intervention

Drug:
• Lexapro (escitalopram)
antidepressant drug selective serotonin reuptake inhibitor (SSRI)

Locations

Country	Name	City	State
United States	Mood Disorders Research Program, St. Luke's-Roosevelt Hospital Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
St. Luke's-Roosevelt Hospital Center	Forest Laboratories

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Week 12	No
Primary	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)	Baseline	No
Secondary	Clinical Global Impressions - Severity (CGI-S)	Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)	Week 12	No
Secondary	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.	Baseline	No
Secondary	Clinical Global Impressions - Severity (CGI-S)	Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)	Baseline	No
Secondary	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.	Week 12	No

External Links

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