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

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: February 11, 2014
Last verified: February 2014

November 29, 2011
February 11, 2014
January 2012
December 2012   (final data collection date for primary outcome measure)
Change From Baseline in MADRS Total Score at Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
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.
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.

Complete list of historical versions of study NCT01488071 on ClinicalTrials.gov Archive Site
  • Change From Baseline in MADRS Total Score at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in HAM-A Total Score at Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change From Baseline in CGI-S Score at Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change in Clinical Status Using CGI-I Score at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Proportion of Patients Who Are in Remission at Week 8 (Remission is Defined as a MADRS Total Score <=10) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Proportion of Patients Who Are in Remission at Week 12 (Remission is Defined as a MADRS Total Score <=10) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in SDS Total Score at Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
A Study of Vortioxetine (Lu AA21004) in Comparison to Agomelatine in Adults Suffering From Major Depression With Inadequate Response to Previous Medication
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: Vortioxetine (Lu AA21004)
    encapsulated tablets, daily, orally
    Other Name: Brintellix®
  • Drug: Agomelatine
    encapsulated tablets, daily, orally
    Other Name: Valdoxan®
  • Experimental: Vortioxetine 10 mg or 20 mg
    Intervention: Drug: Vortioxetine (Lu AA21004)
  • Active Comparator: Agomelatine 25 mg or 50 mg
    Intervention: Drug: Agomelatine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
495
Not Provided
December 2012   (final data collection date for primary outcome measure)

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.

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01488071
14178A, 2011-002362-21
No
H. Lundbeck A/S
H. Lundbeck A/S
Not Provided
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
February 2014

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