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A Study of Lu AA21004 in Comparison to Agomelatine in Adults Suffering From Major Depression Who Did Not Respond Well to Previous Medication

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT01488071
First received: November 29, 2011
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
  Purpose

The objective of the present study is to evaluate whether Lu AA21004 (10 or 20 mg/day) is at least as effective as agomelatine (25 to 50 mg/day) in patients with depressive symptoms that showed inadequate response to Serotonin Reuptake Inhibitors (SRI) antidepressants.


Condition Intervention Phase
Major Depressive Disorder
 Drug: Lu AA21004
Drug: agomelatine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Parallel-group, Active-controlled, Flexible Dose Study Evaluating the Effects of Lu AA21004 Versus Agomelatine in Adult Patients Suffering From Major Depressive Disorder With Inadequate Response to Antidepressant Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • Efficacy of flexible doses of Lu AA21004 vs. flexible doses of agomelatine on depressive symptoms in patients with MDD who have responded inadequately to SRI antidepressant monotherapy as assessed by the change from baseline in MADRS total score [ Time Frame: Baseline and week 8 ] [ Designated as safety issue: No ]

    Major Depressive Disorder (MDD)

    Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60. Higher scores indicate greater severity of symptoms.



Secondary Outcome Measures:
  • Efficacy of flexible doses of Lu AA21004 vs. flexible doses of agomelatine over the 12 weeks of treatment on depressive symptoms as assessed by the change from baseline in MADRS total score [ Time Frame: Baseline and week 1, 2, 3, 4 and 12 ] [ Designated as safety issue: No ]
  • Safety and tolerability of flexible doses of Lu AA21004 vs. flexible doses of agomelatine over the 12 weeks of treatment as assessed by reported adverse events [ Time Frame: From baseline to week 12 ] [ Designated as safety issue: Yes ]

Enrollment: 501
Study Start Date: January 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lu AA21004 Drug: Lu AA21004
10 to 20 mg capsule orally per day
Other Name: Vortioxetine
Active Comparator: agomelatine Drug: agomelatine
25 to 50 mg capsule orally per day
Other Name: Valdoxan

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient is being treated with an SRI antidepressant (monotherapy) that was prescribed to treat Major Depressive Episode (DSM-IV-TR criteria)
  • The response to the current SRI treatment is inadequate and patient agrees to discontinue the current SRI at the baseline
  • MADRS total score ≥22 at the Screening Visit and Baseline
  • The patient, if a woman, must: agree not to try to become pregnant during the study, AND use adequate, highly effective contraception

Exclusion Criteria:

  • The patient has any current Axis I disorders (DSM-IV criteria) other than MDD, General Anxiety Disorder (GAD) and Social Anxiety Disorder (SAD)
  • The patient is at significant risk of suicide
  • The patient is currently receiving formal psychotherapy or other psychoactive medications

Other protocol-defined inclusion and exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01488071

  Show 76 Study Locations
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

No publications provided

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01488071     History of Changes
Other Study ID Numbers: 14178A, 2011-002362-21
Study First Received: November 29, 2011
Last Updated: January 17, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Estonia: The State Agency of Medicine
Sweden: Medical Products Agency

Keywords provided by H. Lundbeck A/S:
Depression
Multimodal antidepressant

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Stress, Psychological
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
 S 20098
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013