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Trial record 53 of 482 for:    ESCITALOPRAM AND Antagonists

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
Sponsor:
Information provided by:
H. Lundbeck A/S

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.


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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


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




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 ]


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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.


Information from the National Library of Medicine

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


Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com

Study Data/Documents: EMA EudraCT Results  This link exits the ClinicalTrials.gov site
Identifier: 2004-005069-39

Publications of Results:
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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01148472     History of Changes
Other Study ID Numbers: 10990
2004-005069-39 ( EudraCT Number )
First Posted: June 22, 2010    Key Record Dates
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:
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Dexetimide
Citalopram
Muscarinic Antagonists
Cholinergic Antagonists
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Duloxetine Hydrochloride
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
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Cholinergic Agents
Serotonin and Noradrenaline Reuptake Inhibitors