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

• ClinicalTrials.gov Identifier: NCT01148472
• Recruitment Status: Completed
• First Posted: June 22, 2010
• Last Update Posted: November 8, 2016
• Sponsor: H. Lundbeck A/S
• Information provided by: H. Lundbeck A/S

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Major Depressive Disorder	Drug: Escitalopram; Drug: Duloxetine	Phase 4

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 294 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Double-blind, Randomised, Multicenter, Comparative Study of Escitalopram and Duloxetine in Outpatients With Major Depressive Disorder
• Study Start Date: September 2005
• Actual Primary Completion Date: September 2006
• Actual Study Completion Date: November 2006

Arms and Interventions

Arm	Intervention/treatment
Experimental: Escitalopram	Drug: Escitalopram; 20mg once daily; orally; Other Name: Cipralex, Lexapro
Active Comparator: Duloxetine	Drug: Duloxetine; 60mg once daily; orally; Other Name: Cymbalta

Outcome Measures

Primary Outcome Measures :

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 [ Time Frame: 24 weeks ]

Secondary Outcome Measures :

1. To compare the efficacy of escitalopram with that of duloxetine per visit over the 24-week study period in outpatients with MDD. [ Time Frame: Up to 24 weeks ]
   Secondary efficacy endpoints will be based on the MADRS, the Hamilton Depression Rating Scale (HAM-D17), the Hamilton Rating Scale for Anxiety (HAM-A), the CGI-S, the CGI-I and the Sheehan Disability Scale (SDS), Remission (MADRS<=12) and response (>=50% decrease from baseline in MADRS).
2. To compare the tolerability and safety of escitalopram with that of duloxetine over the 24-week study period in outpatients with MDD. [ Time Frame: Up to 24 weeks ]
   Adverse events, clinical safety laboratory tests, vital signs
3. 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). [ Time Frame: Up to 24 weeks ]

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:

• 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

Other protocol-defined inclusion and exclusion criteria may apply.

Contacts and Locations

Sponsors and Collaborators

H. Lundbeck A/S

Investigators

• Study Director: Email contact via H. Lundbeck A/S; LundbeckClinicalTrials@lundbeck.com

More Information

Study Data/Documents: EMA EudraCT Results 

Identifier: 2004-005069-39

Publications of Results:

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.

• Responsible Party: H. Lundbeck A/S
• ClinicalTrials.gov Identifier: NCT01148472
• Other Study ID Numbers: 10990; 2004-005069-39 ( EudraCT Number )
• First Posted: June 22, 2010
• Last Update Posted: November 8, 2016
• Last Verified: November 2016

Keywords provided by H. Lundbeck A/S:

Depressive disorder, major; Randomized controlled trials; Antidepressive agents

Additional relevant MeSH terms:

Disease; Depressive Disorder; Depression; Depressive Disorder, Major; Pathologic Processes; Mood Disorders; Mental Disorders; Behavioral Symptoms; Duloxetine Hydrochloride; 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; Peripheral Nervous System Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Analgesics; Sensory System Agents; Dopamine Agents