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Fixed Dose Comparison of Escitalopram to an Active Comparator in Severely Depressed Patients

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

escitalopram

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder

Eligibility Criteria

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

Inclusion Criteria:

Patients must meet DSM-IV criteria for Major Depressive Disorder.
Patients must have severe depression.
MADRS greater than or equal to 30

Exclusion Criteria:

Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control.
Patients who are considered a suicide risk.
Patients who currently meet DSM-IV criteria for: a principal diagnosis for Axis I disorder other than MDD (comorbid GAD is allowed), bipolar disorder, schizophrenia or any psychotic disorder, obsessive-compulsive disorder, dysthymia.
Patients with a family history of bipolar disorder, schizophrenia, or any psychotic disorder.
Patients with history of any psychotic disorder or any psychotic feature.

Sites / Locations

For information regarding investigative sites, contact Forest Professional Affairs

Outcomes

Primary Outcome Measures

Time to premature discontinuation

Secondary Outcome Measures

Montgomery Asberg Depression Rating Scale (MADRS)

Full Information

NCT ID

NCT00384436

First Posted

October 3, 2006

Last Updated

January 3, 2008

Sponsor

Forest Laboratories

1. Study Identification

Unique Protocol Identification Number

NCT00384436

Brief Title

Fixed Dose Comparison of Escitalopram to an Active Comparator in Severely Depressed Patients

Official Title

Fixed Dose Comparison of Escitalopram to an Active Comparator in Severely Depressed Patients

Study Type

Interventional

2. Study Status

Record Verification Date

January 2008

Overall Recruitment Status

Completed

Study Start Date

October 2006 (undefined)

Primary Completion Date

October 2007 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Forest Laboratories

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of escitalopram to an active comparator in severely depressed patients

Detailed Description

Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults. This study is designed to evaluate the safety and efficacy of escitalopram and an active comparator in severely depressed patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

Major Depressive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

580 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

escitalopram

Primary Outcome Measure Information:

Title

Time to premature discontinuation

Secondary Outcome Measure Information:

Title

Montgomery Asberg Depression Rating Scale (MADRS)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must meet DSM-IV criteria for Major Depressive Disorder. Patients must have severe depression. MADRS greater than or equal to 30 Exclusion Criteria: Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control. Patients who are considered a suicide risk. Patients who currently meet DSM-IV criteria for: a principal diagnosis for Axis I disorder other than MDD (comorbid GAD is allowed), bipolar disorder, schizophrenia or any psychotic disorder, obsessive-compulsive disorder, dysthymia. Patients with a family history of bipolar disorder, schizophrenia, or any psychotic disorder. Patients with history of any psychotic disorder or any psychotic feature.

Facility Information:

Facility Name

For information regarding investigative sites, contact Forest Professional Affairs

City

St Louis

State/Province

Missouri

ZIP/Postal Code

63045

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22559255

Citation

Bose A, Tsai J, Li D. Early non-response in patients with severe depression: escitalopram up-titration versus switch to duloxetine. Clin Drug Investig. 2012 Jun 1;32(6):373-85. doi: 10.2165/11631890-000000000-00000.

Results Reference

derived

PubMed Identifier

21438794

Citation

Signorovitch J, Ramakrishnan K, Ben-Hamadi R, Yu AP, Wu EQ, Dworak H, Erder MH. Remission of major depressive disorder without adverse events: a comparison of escitalopram versus serotonin norepinephrine reuptake inhibitors. Curr Med Res Opin. 2011 Jun;27(6):1089-96. doi: 10.1185/03007995.2011.567255. Epub 2011 Mar 28. Erratum In: Curr Med Res Opin. 2011 Sep;27(9):1708.

Results Reference

derived

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Fixed Dose Comparison of Escitalopram to an Active Comparator in Severely Depressed Patients

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