Efficacy and Tolerability of Escitalopram and Duloxetine in Outpatients With Major Depressive Disorder
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|ClinicalTrials.gov Identifier: NCT01148472|
Recruitment Status : Completed
First Posted : June 22, 2010
Last Update Posted : November 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Escitalopram Drug: Duloxetine||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||294 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
20mg once daily; orally
Other Name: Cipralex, Lexapro
|Active Comparator: Duloxetine||
60mg once daily; orally
Other Name: Cymbalta
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01148472
|Study Director:||Email contact via H. Lundbeck A/S||LundbeckClinicalTrials@lundbeck.com|