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A Study of Vortioxetine (Lu AA21004) in Comparison to Agomelatine in Adults Suffering From Major Depression With Inadequate Response to Previous Medication (REVIVE)

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ClinicalTrials.gov Identifier: NCT01488071
Recruitment Status : Completed
First Posted : December 8, 2011
Results First Posted : March 26, 2014
Last Update Posted : March 26, 2014
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Tracking Information
First Submitted Date  ICMJE November 29, 2011
First Posted Date  ICMJE December 8, 2011
Results First Submitted Date  ICMJE December 19, 2013
Results First Posted Date  ICMJE March 26, 2014
Last Update Posted Date March 26, 2014
Study Start Date  ICMJE January 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2014)
Change From Baseline in MADRS Total Score at Week 8 [ Time Frame: Baseline and Week 8 ]
The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
Original Primary Outcome Measures  ICMJE
 (submitted: December 6, 2011)
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 ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2014)
  • Change From Baseline in MADRS Total Score at Week 12 [ Time Frame: Baseline and Week 12 ]
  • Change From Baseline in HAM-A Total Score at Week 8 [ Time Frame: Baseline and Week 8 ]
    The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56; higher score indicates greater anxiety, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
  • Change From Baseline in HAM-A Total Score at Week 12 [ Time Frame: Baseline and Week 12 ]
  • Change From Baseline in CGI-S Score at Week 8 [ Time Frame: Baseline and Week 8 ]
    The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating. Higher score indicates that the subject is more ill, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
  • Change From Baseline in CGI-S Score at Week 12 [ Time Frame: Baseline and Week 12 ]
  • Change in Clinical Status Using CGI-I Score at Week 8 [ Time Frame: Week 8 ]
    The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment. Higher score = more affected.
  • Change in Clinical Status Using CGI-I Score at Week 12 [ Time Frame: Week 12 ]
  • Proportion of Patients Who Respond at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) [ Time Frame: Baseline and Week 8 ]
  • Proportion of Patients Who Respond at Week 12 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline) [ Time Frame: Baseline and Week 12 ]
  • Proportion of Patients Who Are in Remission at Week 8 (Remission is Defined as a MADRS Total Score <=10) [ Time Frame: Week 8 ]
  • Proportion of Patients Who Are in Remission at Week 12 (Remission is Defined as a MADRS Total Score <=10) [ Time Frame: Week 12 ]
  • Change From Baseline in SDS Total Score at Week 8 [ Time Frame: Baseline and Week 8 ]
    The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
  • Change From Baseline in SDS Total Score at Week 12 [ Time Frame: Baseline and Week 12 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2011)
  • 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 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Vortioxetine (Lu AA21004) in Comparison to Agomelatine in Adults Suffering From Major Depression With Inadequate Response to Previous Medication
Official Title  ICMJE A Randomised, Double-blind, Parallel-group, Active-controlled, Flexible Dose Study Evaluating the Effects of [Vortioxetine] Lu AA21004 Versus Agomelatine in Adult Patients Suffering From Major Depressive Disorder With Inadequate Response to Antidepressant Treatment
Brief Summary The objective of the present study is to evaluate whether vortioxetine (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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: Vortioxetine (Lu AA21004)
    encapsulated tablets, daily, orally
    Other Name: Brintellix®
  • Drug: Agomelatine
    encapsulated tablets, daily, orally
    Other Name: Valdoxan®
Study Arms  ICMJE
  • Experimental: Vortioxetine 10 mg or 20 mg
    Intervention: Drug: Vortioxetine (Lu AA21004)
  • Active Comparator: Agomelatine 25 mg or 50 mg
    Intervention: Drug: Agomelatine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2014)
495
Original Estimated Enrollment  ICMJE
 (submitted: December 6, 2011)
500
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The patient is being treated with a serotonin reuptake inhibitor (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
  • Montgomery Åsberg Depression Rating Scale (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 Major Depressive Disorder (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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Austria,   Belgium,   Bulgaria,   Czech Republic,   Estonia,   Germany,   Italy,   Lithuania,   Poland,   Romania,   Russian Federation,   Spain,   Sweden,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT01488071
Other Study ID Numbers  ICMJE 14178A
2011-002362-21 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H. Lundbeck A/S
Study Sponsor  ICMJE H. Lundbeck A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
PRS Account H. Lundbeck A/S
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP