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

Tracking Information

• First Submitted Date: June 17, 2010
• First Posted Date: June 22, 2010
• Last Update Posted Date: November 8, 2016
• Study Start Date: September 2005
• Actual Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 21, 2010): 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 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 21, 2010)

• 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).
• 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
• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Tolerability of Escitalopram and Duloxetine in Outpatients With Major Depressive Disorder
• Official Title: A Double-blind, Randomised, Multicenter, Comparative Study of Escitalopram and Duloxetine in Outpatients With Major Depressive Disorder
• 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.

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 Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Major Depressive Disorder

Intervention

• Drug: Escitalopram
  20mg once daily; orally
  Other Name: Cipralex, Lexapro
• Drug: Duloxetine
  60mg once daily; orally
  Other Name: Cymbalta

Study Arms

• Experimental: Escitalopram
  Intervention: Drug: Escitalopram
• Active Comparator: Duloxetine
  Intervention: Drug: Duloxetine

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 21, 2010): 294
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: November 2006
• Actual Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT01148472
• Other Study ID Numbers: 10990; 2004-005069-39 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: H. Lundbeck A/S
• Study Sponsor: H. Lundbeck A/S
• Collaborators: Not Provided

Investigators

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

• PRS Account: H. Lundbeck A/S
• Verification Date: November 2016