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Efficacy and Tolerability of Escitalopram and Duloxetine in Outpatients With Major Depressive Disorder

NCT ID: NCT01148472

Last Updated: 2016-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

294 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-11-30

Brief Summary

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The primary objective of this study was to compare the efficacy of escitalopram with that of duloxetine in outpatients with Major Depressive Disorder (MDD) after 24 weeks of treatment. The study hypothesis was that there were clinically important differences between the two drugs in terms of efficacy and adverse event profiles.

Detailed Description

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Depression is a common mental disorder that presents with depressed mood, loss of interest or pleasure, disturbed sleep or appetite, low energy, feelings of guilt or low self-worth, and poor concentration. The lifetime prevalence of Major Depressive Disorder (MDD) in community samples is 10-25% for women and 5-12% for men. Depression may become chronic or recurrent and lead to substantial impairments in an individual's ability to take care of his or her everyday responsibilities. At its worst, depression may lead to suicide. Depression is recurrent in 75-80% of patients and becomes chronic in 15-20% of depressed patients.

The selective serotonin reuptake inhibitors (SSRIs) have become the leading class of antidepressants throughout the world. The efficacy and safety of SSRIs in the treatment of depression has been demonstrated in several clinical trials. With respect to safety, the studies show an advantage for the SSRIs over the older antidepressants. If the prescribing physicians are to make a well-founded judgement in their choice of drug factors like efficacy, safety, quality of life, and health economics must be taken into consideration. The primary aim of this study is to compare the efficacy of escitalopram with that of the serotonin norepinephrine reuptake inhibitors (SNRIs) duloxetine in the treatment of MDD.

Conditions

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Major Depressive Disorder

Keywords

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Depressive disorder, major Randomized controlled trials Antidepressive agents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Escitalopram

Group Type EXPERIMENTAL

Escitalopram

Intervention Type DRUG

20mg once daily; orally

Duloxetine

Group Type ACTIVE_COMPARATOR

Duloxetine

Intervention Type DRUG

60mg once daily; orally

Interventions

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Escitalopram

20mg once daily; orally

Intervention Type DRUG

Duloxetine

60mg once daily; orally

Intervention Type DRUG

Other Intervention Names

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Cipralex, Lexapro Cymbalta

Eligibility Criteria

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Inclusion Criteria

* The patient suffers from a primary diagnosis of MDD according to DSM-IV-TR criteria (classification code 296.xx; current episode assessed using the MINI)
* The patient has a MADRS total score \>=26 and a CGI-S score \>=4 at the Baseline Visit

Exclusion Criteria

* Any current psychiatric disorder other than MDD as defined in the DSM-IV TR
* Female patients of childbearing potential who are not using effective contraception
* Use of any psychoactive medication 2 weeks prior to screening and during the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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H. Lundbeck A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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H. Lundbeck A/S

Principal Investigators

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Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

[email protected]

References

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Wade A, Gembert K, Florea I. A comparative study of the efficacy of acute and continuation treatment with escitalopram versus duloxetine in patients with major depressive disorder. Curr Med Res Opin. 2007 Jul;23(7):1605-14. doi: 10.1185/030079907x210732.

Reference Type RESULT
PMID: 17559755 (View on PubMed)

Study Documents

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Document Type: EMA EudraCT Results

View Document

Other Identifiers

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2004-005069-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

10990

Identifier Type: -

Identifier Source: org_study_id