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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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: Vortioxetine (Lu AA21004)
Drug: Agomelatine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
In- or outpatients who had been treated with antidepressant selective serotonin reuptake inhibitor (SSRI) or selective noradrenaline reuptake inhibitor (SNRI) monotherapy that was prescribed to treat a single episode of Major Depressive Disorder (MDD) or recurrent MDD.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study will consist of a screening period of 4 to 10 days before the Baseline Visit, followed by a 12-week treatment period with vortioxetine or agomelatine. A safety follow-up will be done approximately 4 weeks after the Completion/Withdrawal Visit.

Reporting Groups
  Description
Vortioxetine 10 mg or 20 mg encapsulated tablets, daily, orally
Agomelatine 25 mg or 50 mg encapsulated tablets, daily, orally

Participant Flow:   Overall Study
    Vortioxetine 10 mg or 20 mg   Agomelatine 25 mg or 50 mg
STARTED   253 [1]   242 [2] 
COMPLETED   200   179 
NOT COMPLETED   53   63 
Adverse Event                15                23 
Lack of Efficacy                11                17 
Non-compliance with study drug                2                0 
Protocol Violation                5                7 
Withdrawal of Consent                14                12 
Lost to Follow-up                1                0 
Administrative or Other Reason(s)                5                4 
[1] all-patients-treated set (APTS)
[2] APTS



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Age and Gender: All-patients-treated set (APTS) – all patients in the APRS who took at least one dose of investigational medicinal product (IMP).

Study Specific Characteristics: Full-analysis set (FAS) - all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score.

Reporting Groups
  Description
Vortioxetine 10 mg or 20 mg encapsulated tablets, daily, orally
Agomelatine 25 mg or 50 mg encapsulated tablets, daily, orally
Total Total of all reporting groups

Baseline Measures
   Vortioxetine 10 mg or 20 mg   Agomelatine 25 mg or 50 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 253   242   495 
Age 
[Units: Years]
Mean (Standard Deviation) 		 47.0  (12.4)   45.6  (12.4)   46.3  (12.4) 
Gender 
[Units: Participants]
 		     
Female   195   175   370 
Male   58   67   125 
MADRS: Baseline Total Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation) 		 29.1  (4.4)   28.7  (4.0)   28.9  (4.2) 
[1] 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 - 60. The higher the score, the more severe.
HAM-A: Baseline Total Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation) 		 21.6  (6.3)   21.4  (6.2)   21.5  (6.2) 
[1] 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.
CGI-S Baseline Severity Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation) 		 4.4  (0.6)   4.4  (0.6)   4.4  (0.6) 
[1] 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 patient is more ill.
SDS Total Baseline Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation) 		 19.2  (5.3)   19.3  (5.2)   19.3  (5.3) 
[1] 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.


  Outcome Measures

1.  Primary:   Change From Baseline in MADRS Total Score at Week 8   [ Time Frame: Baseline and Week 8 ]
  Show Outcome Measure 1

2.  Secondary:   Change From Baseline in MADRS Total Score at Week 12   [ Time Frame: Baseline and Week 12 ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline in HAM-A Total Score at Week 8   [ Time Frame: Baseline and Week 8 ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline in HAM-A Total Score at Week 12   [ Time Frame: Baseline and Week 12 ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline in CGI-S Score at Week 8   [ Time Frame: Baseline and Week 8 ]
  Show Outcome Measure 5

6.  Secondary:   Change From Baseline in CGI-S Score at Week 12   [ Time Frame: Baseline and Week 12 ]
  Show Outcome Measure 6

7.  Secondary:   Change in Clinical Status Using CGI-I Score at Week 8   [ Time Frame: Week 8 ]
  Show Outcome Measure 7

8.  Secondary:   Change in Clinical Status Using CGI-I Score at Week 12   [ Time Frame: Week 12 ]
  Show Outcome Measure 8

9.  Secondary:   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 ]
  Show Outcome Measure 9

10.  Secondary:   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 ]
  Show Outcome Measure 10

11.  Secondary:   Proportion of Patients Who Are in Remission at Week 8 (Remission is Defined as a MADRS Total Score <=10)   [ Time Frame: Week 8 ]
  Show Outcome Measure 11

12.  Secondary:   Proportion of Patients Who Are in Remission at Week 12 (Remission is Defined as a MADRS Total Score <=10)   [ Time Frame: Week 12 ]
  Show Outcome Measure 12

13.  Secondary:   Change From Baseline in SDS Total Score at Week 8   [ Time Frame: Baseline and Week 8 ]
  Show Outcome Measure 13

14.  Secondary:   Change From Baseline in SDS Total Score at Week 12   [ Time Frame: Baseline and Week 12 ]
  Show Outcome Measure 14


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: H. Lundbeck A/S
Organization: H. Lundbeck A/S
phone: +45 36301311
e-mail: LundbeckClinicalTrials@lundbeck.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01488071     History of Changes
Other Study ID Numbers: 14178A
2011-002362-21 ( EudraCT Number )
First Submitted: November 29, 2011
First Posted: December 8, 2011
Results First Submitted: December 19, 2013
Results First Posted: March 26, 2014
Last Update Posted: March 26, 2014