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

NCT01148472 | Completed Phase 4

• 2 other identifiers: 109902004-005069-39
• Study Type: interventional
• Target: 294
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Major Depressive Disorder

Keywords

Depressive disorder, major; Randomized controlled trials; Antidepressive agents

Outcome Measures

Primary Outcomes (1)

• To compare the efficacy of escitalopram with that of duloxetine in outpatients with Major Depressive Disorder (MDD) as assessed by change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score at the end of 24 weeks

  24 weeks

Secondary Outcomes (3)

• To compare the efficacy of escitalopram with that of duloxetine per visit over the 24-week study period in outpatients with MDD.

  Up to 24 weeks

• To compare the tolerability and safety of escitalopram with that of duloxetine over the 24-week study period in outpatients with MDD.

  Up to 24 weeks

• To evaluate the discontinuation emergent signs and symptoms during and after taper-down treatment with escitalopram or duloxetine after 24 weeks of treatment assessed by the Discontinuation Emergent Signs and Symptoms Scale (DESS).

  Up to 24 weeks

Study Arms (2)

Escitalopram

EXPERIMENTAL

Drug: Escitalopram

Duloxetine

ACTIVE COMPARATOR

Drug: Duloxetine

Interventions

Escitalopram DRUG

20mg once daily; orally

Also known as: Cipralex, Lexapro

Escitalopram

Duloxetine DRUG

60mg once daily; orally

Also known as: Cymbalta

Duloxetine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Related Publications (1)

• 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.

  PMID: 17559755 RESULT

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Escitalopram; Dexetimide; Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Thiophenes; Sulfur Compounds

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 17, 2010
• First Posted: June 22, 2010
• Study Start: September 1, 2005
• Primary Completion: September 1, 2006
• Study Completion: November 1, 2006
• Last Updated: November 8, 2016

Record last verified: 2016-11