Escitalopram in the Treatment of Dysthymic Disorder, Double Blind

NCT ID: NCT00220701

Last Updated: 2015-11-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-06-30
• Study Completion Date: 2009-01-31

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.

Conditions

Dysthymic Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

escitalopram

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

Group Type: EXPERIMENTAL

Lexapro (escitalopram)

Intervention Type: DRUG

antidepressant drug selective serotonin reuptake inhibitor (SSRI)

Placebo

inactive comparator

Group Type: PLACEBO_COMPARATOR

Lexapro (escitalopram)

Intervention Type: DRUG

antidepressant drug selective serotonin reuptake inhibitor (SSRI)

Interventions

Lexapro (escitalopram)

antidepressant drug selective serotonin reuptake inhibitor (SSRI)

Intervention Type: DRUG

Other Intervention Names

lexapro; escitalopram; s-citalopram; d-citalopram

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Forest Laboratories

INDUSTRY

Sponsor Role: collaborator

St. Luke's-Roosevelt Hospital Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David J. Hellerstein, MD

Role: PRINCIPAL_INVESTIGATOR

St. Luke's-Roosevelt Hospital, and NY State Psychiatric Institute

Locations

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

New York, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 21811192 (View on PubMed)

Related Links

http://www.DepressionNY.com

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

Other Identifiers

LXP-MD-34

Identifier Type: -

Identifier Source: org_study_id