Randomised Placebo-controlled Duloxetine-referenced Study of Efficacy and Safety of 5 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Elderly Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00811252
First received: December 17, 2008
Last updated: December 23, 2013
Last verified: December 2013
Results First Received: October 28, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: 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 mainly recruited via psychiatric, psycho-geriatric, and geriatric inpatient or outpatient settings.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study consisted of a Screening Period; an 8-week Core Treatment Period; a 1-week double-blind down-taper period (Week 9); and a 4-week Safety Follow-up Period after completion/withdrawal (Weeks 8 to 12).

Reporting Groups
  Description
Placebo capsules; daily; orally
Vortioxetine 5 mg encapsulated tablets; daily; orally
Duloxetine 60 mg encapsulated tablets; daily; orally

Participant Flow:   Overall Study
    Placebo     Vortioxetine 5 mg     Duloxetine 60 mg  
STARTED     145     156     151  
COMPLETED     128     136     128  
NOT COMPLETED     17     20     23  
Adverse Event                 6                 10                 15  
Lack of Efficacy                 7                 2                 0  
Protocol Violation                 3                 3                 2  
Withdrawal of Consent                 1                 2                 2  
Lost to Follow-up                 0                 0                 2  
Administrative or Other Reasons                 0                 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.
Full-analysis set (FAS) – all patients in the all-patients-treated set (APTS) who had at least one valid post-baseline assessment of the primary efficacy variable

Reporting Groups
  Description
Placebo capsules; daily; orally
Vortioxetine 5 mg encapsulated tablets; daily; orally
Duloxetine 60 mg encapsulated tablets; daily; orally
Total Total of all reporting groups

Baseline Measures
    Placebo     Vortioxetine 5 mg     Duloxetine 60 mg     Total  
Number of Participants  
[units: participants]
  145     156     151     452  
Age  
[units: years]
Mean ± Standard Deviation
  70.3  ± 4.4     70.5  ± 4.8     70.9  ± 5.5     70.6  ± 4.9  
Gender  
[units: participants]
       
Female     90     107     100     297  
Male     55     49     51     155  
HAM-D-24 [1]
[units: units on a scale]
Mean ± Standard Deviation
  29.4  ± 5.1     29.2  ± 5.0     28.5  ± 4.9     29.0  ± 5.0  
MADRS [2]
[units: units on a scale]
Mean ± Standard Deviation
  30.3  ± 3.2     30.7  ± 3.6     30.4  ± 3.1     30.5  ± 3.3  
HAM-A [3]
[units: units on a scale]
Mean ± Standard Deviation
  19.5  ± 5.7     19.9  ± 5.8     19.2  ± 6.5     19.5  ± 6.0  
CGI-S [4]
[units: units on a scale]
Mean ± Standard Deviation
  4.7  ± 0.7     4.8  ± 0.7     4.7  ± 0.8     4.7  ± 0.7  
GDS [5]
[units: units on a scale]
Mean ± Standard Deviation
  7.7  ± 2.0     7.4  ± 2.2     7.7  ± 2.3     7.6  ± 2.2  
[1] The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe.
[2] 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.
[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 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.
[5] The Geriatric Depression Scale (GDS) is a patient self-rating scale designed for the screening of depression in the elderly. It has also been validated as a measure of depression severity. The original version consists of 30 questions with a yes/no answer. In this study, the short 15-item version was used. The total score ranges from 0 to 15, with 15 representing maximum severity.



  Outcome Measures
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1.  Primary:   Change From Baseline in HAM-D-24 Total Score After 8 Weeks of Treatment   [ Time Frame: Baseline and Week 8 ]

2.  Secondary:   Change From Baseline in HAM-D-24 Total Score After 6 Weeks of Treatment   [ Time Frame: Baseline and Week 6 ]

3.  Secondary:   Change From Baseline in HAM-D-24 Total Score After 4 Weeks of Treatment   [ Time Frame: Baseline and Week 4 ]

4.  Secondary:   Change From Baseline in HAM-D-24 Total Score After 2 Weeks of Treatment   [ Time Frame: Baseline and Week 2 ]

5.  Secondary:   Change From Baseline in HAM-D-24 Total Score After 1 Week of Treatment   [ Time Frame: Baseline and Week 1 ]

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

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

8.  Secondary:   Change From Baseline in CGI-S Score After 8 Weeks of Treatment   [ Time Frame: Baseline and Week 8 ]

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

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

11.  Secondary:   Proportion of Responders at Week 8 (Response Defined as a >=50% Reduction in the HAM-D-24 Total Score)   [ Time Frame: Week 8 ]

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

13.  Secondary:   Risk of Suicidality Using C-SSRS Scores   [ Time Frame: Up to 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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.


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


Publications of Results:

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00811252     History of Changes
Other Study ID Numbers: 12541A, 2008-002901-38
Study First Received: December 17, 2008
Results First Received: October 28, 2013
Last Updated: December 23, 2013
Health Authority: Canada: Health Canada
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
Sweden: Medical Products Agency
Ukraine: Ministry of Health
United States: Food and Drug Administration