Randomised Placebo-controlled Duloxetine-referenced Study of Efficacy and Safety of 15 and 20 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT01140906
First received: June 9, 2010
Last updated: December 23, 2013
Last verified: December 2013
Results First Received: October 28, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: Placebo
Drug: Vortioxetine (Lu AA21004)
Drug: Duloxetine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were selected from psychiatric settings (private practices), outpatient clinics, and inpatient hospitals.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
At the Baseline Visit, patients who fulfilled the selection criteria were assigned to treatment with either placebo, vortioxetine 15 or 20 mg/day, or duloxetine 60 mg/day in a 1:1:1:1 ratio.

Reporting Groups
  Description
Placebo capsules, daily, orally
Vortioxetine 15 mg encapsulated tablets, daily, orally
Vortioxetine 20 mg encapsulated tablets, daily, orally
Duloxetine 60 mg encapsulated capsules, daily, orally

Participant Flow:   Overall Study
    Placebo     Vortioxetine 15 mg     Vortioxetine 20 mg     Duloxetine 60 mg  
STARTED     158     151     151     147  
COMPLETED     133     117     125     131  
NOT COMPLETED     25     34     26     16  
Adverse Event                 7                 10                 17                 7  
Lack of Efficacy                 6                 8                 2                 1  
Non-compliance                 0                 1                 0                 1  
Protocol Violation                 5                 3                 2                 1  
Withdrawal of consent                 6                 6                 2                 2  
Lost to Follow-up                 1                 1                 0                 2  
Administrative or other reason                 0                 5                 3                 2  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Placebo capsules, daily, orally
Vortioxetine 15 mg encapsulated tablets, daily, orally
Vortioxetine 20 mg encapsulated tablets, daily, orally
Duloxetine 60 mg encapsulated capsules, daily, orally
Total Total of all reporting groups

Baseline Measures
    Placebo     Vortioxetine 15 mg     Vortioxetine 20 mg     Duloxetine 60 mg     Total  
Number of Participants  
[units: participants]
  158     151     151     147     607  
Age  
[units: years]
Mean ± Standard Deviation
  48.1  ± 13.1     47.0  ± 14.6     46.2  ± 13.4     45.6  ± 13.6     46.7  ± 13.7  
Gender  
[units: participants]
         
Female     110     97     91     102     400  
Male     48     54     60     45     207  
MADRS baseline total score [1]
[units: units on a scale]
Mean ± Standard Deviation
  31.5  ± 3.6     31.8  ± 3.4     31.2  ± 3.4     31.2  ± 3.5     31.4  ± 3.5  
CGI-S baseline severity score [2]
[units: units on a scale]
Mean ± Standard Deviation
  4.9  ± 0.7     4.9  ± 0.6     4.8  ± 0.7     4.8  ± 0.7     4.8  ± 0.7  
HAM-A baseline total score [3]
[units: units on a scale]
Mean ± Standard Deviation
  20.8  ± 6.6     21.3  ± 6.8     20.4  ± 6.9     20.5  ± 6.7     20.8  ± 6.7  
SDS total baseline score [4]
[units: units on a scale]
Mean ± Standard Deviation
  19.8  ± 6.0     20.6  ± 5.3     20.7  ± 4.8     20.5  ± 4.4     20.4  ± 5.2  
[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. 9 of the items are based on patient report, and 1 is based on the rater's observation of the patients. Total score from 0 to 60. The higher the score, the more severe.
[2] 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.
[3] 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. The higher the score, the more severe.
[4] 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
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1.  Primary:   Change From Baseline in MADRS Total Score After 8 Weeks of Treatment.   [ Time Frame: Baseline and Week 8 ]

2.  Secondary:   Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)   [ Time Frame: Week 8 ]

3.  Secondary:   Change in Clinical Status Using CGI-I Score at Week 8   [ Time Frame: Week 8 ]

4.  Secondary:   Change From Baseline in MADRS Total Score After 8 Weeks of Treatment in Patients With Baseline HAM-A Total Score ≥20   [ Time Frame: Baseline and Week 8 ]

5.  Secondary:   Proportion of Remitters at Week 8 (Remission Defined as a MADRS Total Score <=10)   [ Time Frame: Week 8 ]

6.  Secondary:   Change From Baseline in SDS Total Score After 8 Weeks of Treatment   [ Time Frame: Baseline and Week 8 ]

7.  Secondary:   Change From Baseline in ASEX Total Score After 8 Weeks of Treatment   [ Time Frame: Baseline and Week 8 ]

8.  Secondary:   Potential Discontinuation Symptoms After Abrupt Discontinuation of Treatment With Vortioxetine   [ Time Frame: Change from Week 8 in DESS total score analyzed at Week 10 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.


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.  


Results Point of Contact:  
Name/Title: H. Lundbeck A/S
Organization: H. Lundbeck A/S
phone: +45 3630 1311
e-mail: LundbeckClinicalTrials@lundbeck.com


No publications provided


Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01140906     History of Changes
Other Study ID Numbers: 13267A, 2009-017523-26
Study First Received: June 9, 2010
Results First Received: October 28, 2013
Last Updated: December 23, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Estonia: The State Agency of Medicine
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Norway: Norwegian Medicines Agency
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
Sweden: Medical Products Agency
Ukraine: State Pharmacological Center - Ministry of Health