Efficacy and Tolerability of Escitalopram and Duloxetine in Outpatients With Major Depressive Disorder
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Escitalopram
Duloxetine
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depressive disorder, major, Randomized controlled trials, Antidepressive agents
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Escitalopram
Duloxetine
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
To compare the efficacy of escitalopram with that of duloxetine per visit over the 24-week study period in outpatients with MDD.
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.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01148472
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
H. Lundbeck A/S
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Depressive disorder, major, Randomized controlled trials, Antidepressive agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
294 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Escitalopram
Arm Type
Experimental
Arm Title
Duloxetine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Cipralex, Lexapro
Intervention Description
20mg once daily; orally
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Other Intervention Name(s)
Cymbalta
Intervention Description
60mg once daily; orally
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To compare the efficacy of escitalopram with that of duloxetine per visit over the 24-week study period in outpatients with MDD.
Description
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).
Time Frame
Up to 24 weeks
Title
To compare the tolerability and safety of escitalopram with that of duloxetine over the 24-week study period in outpatients with MDD.
Description
Adverse events, clinical safety laboratory tests, vital signs
Time Frame
Up to 24 weeks
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@lundbeck.com
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
17559755
Citation
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.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
EMA EudraCT Results
Available IPD/Information URL
https://www.clinicaltrialsregister.eu/ctr-search/trial/2004-005069-39/results
Available IPD/Information Identifier
2004-005069-39
Learn more about this trial
Efficacy and Tolerability of Escitalopram and Duloxetine in Outpatients With Major Depressive Disorder
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