Escitalopram in the Treatment of Dysthymic Disorder, Double Blind

• ClinicalTrials.gov Identifier: NCT00220701
• Recruitment Status: Completed
• First Posted: September 22, 2005
• Results First Posted: November 25, 2014
• Last Update Posted: November 11, 2015
• Sponsor: St. Luke's-Roosevelt Hospital Center
• Collaborator: Forest Laboratories
• Information provided by (Responsible Party): St. Luke's-Roosevelt Hospital Center

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.

Condition or disease	Intervention/treatment	Phase
Dysthymic Disorder	Drug: Lexapro (escitalopram)	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Double-Blind Placebo-Controlled Study of Escitalopram in the Treatment of Dysthymic Disorder
• Study Start Date: June 2002
• Actual Primary Completion Date: November 2008
• Actual Study Completion Date: January 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: escitalopram; Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.	Drug: Lexapro (escitalopram); antidepressant drug selective serotonin reuptake inhibitor (SSRI); Other Names: lexapro; escitalopram; s-citalopram; d-citalopram
Placebo Comparator: Placebo; inactive comparator	Drug: Lexapro (escitalopram); antidepressant drug selective serotonin reuptake inhibitor (SSRI); Other Names: lexapro; escitalopram; s-citalopram; d-citalopram

Outcome Measures

Primary Outcome Measures :

1. Hamilton-Depression Rating Scale (HDRS-24 Items) [ Time Frame: Week 12 ]
   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)
2. Hamilton-Depression Rating Scale (HDRS-24 Items) [ Time Frame: Baseline ]
   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 :

1. Clinical Global Impressions - Severity (CGI-S) [ Time Frame: Week 12 ]
   Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)
2. Beck Depression Inventory (BDI) [ Time Frame: Baseline ]
   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.
3. Clinical Global Impressions - Severity (CGI-S) [ Time Frame: Baseline ]
   Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology)
4. Beck Depression Inventory (BDI) [ Time Frame: Week 12 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, New York

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

New York, New York, United States, 10019

Sponsors and Collaborators

St. Luke's-Roosevelt Hospital Center

Forest Laboratories

Investigators

• Principal Investigator: David J. Hellerstein, MD; St. Luke's-Roosevelt Hospital, and NY State Psychiatric Institute

More Information

Additional Information:

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

Publications of Results:

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.

• Responsible Party: St. Luke's-Roosevelt Hospital Center
• ClinicalTrials.gov Identifier: NCT00220701
• Other Study ID Numbers: LXP-MD-34
• First Posted: September 22, 2005
• Results First Posted: November 25, 2014
• Last Update Posted: November 11, 2015
• Last Verified: November 2007

Keywords provided by St. Luke's-Roosevelt Hospital Center:

Dysthymic Disorder; Depression; Chronic Depression; Escitalopram

Additional relevant MeSH terms:

Disease; Dysthymic Disorder; Pathologic Processes; Depressive Disorder; Mood Disorders; Mental Disorders; Dexetimide; Citalopram; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Antidepressive Agents, Second-Generation; Antidepressive Agents; Psychotropic Drugs; Antiparkinson Agents; Anti-Dyskinesia Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents