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Trial record 1 of 2 for:    LuAA21004_314
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Safety and Tolerability of Vortioxetine (LuAA21004) - Open Label Extension Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01152996
First Posted: June 29, 2010
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Takeda
Results First Submitted: April 29, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Depressive Disorder, Major
Intervention: Drug: Vortioxetine

  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
Participants took part in the study at 143 investigative sites in the United States from 07 Sep 2010 to 31 May 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients who completed Studies LuAA21004_315 (NCT01153009), LuAA21004_316 (NCT01163266), and LuAA21004_317 (NCT01179516) and were willing to continue, and judged by the investigator to benefit from a 52-week continuation treatment with Lu AA21004, were enrolled and received flexible doses of study drug, based on patient response and tolerability.

Reporting Groups
  Description
Vortioxetine Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.

Participant Flow:   Overall Study
    Vortioxetine
STARTED   1075 
Treated   1073 
COMPLETED   538 
NOT COMPLETED   537 
Withdrawal by Subject                142 
Adverse Event                115 
Lost to Follow-up                112 
Lack of Efficacy                68 
Noncompliance                41 
Other                36 
Protocol Violation                22 
Elevated liver enzymes                1 



  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
Vortioxetine Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.

Baseline Measures
   Vortioxetine 
Overall Participants Analyzed 
[Units: Participants]
 1075 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.5  (12.05) 
Gender 
[Units: Participants]
 
Female   790 
Male   285 
Race/Ethnicity, Customized 
[Units: Participants]
 
Caucasian (or White, including Hispanic)   813 
Black/African American   249 
Asian   7 
American Indian/Alaska Native   5 
Native Hawaiian/Other Pacific Islander   1 
Race/Ethnicity, Customized 
[Units: Participants]
 
Hispanic or Latino   104 
Non-Hispanic and Non-Latino   971 
Weight 
[Units: Kg)]
Mean (Standard Deviation)
 88.77  (24.160) 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 31.60  (8.061) 
Height 
[Units: Cm]
Mean (Standard Deviation)
 167.44  (9.456) 
Montgomery Åsberg Depression Rating Scale (MADRS) total score [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 20.0  (10.70) 
[1] MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms.
Hamilton Anxiety Scale (HAM-A) total score [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 11.6  (6.65) 
[1] HAM-A is a 14 item rating scale to quantify anxiety symptomatology severity (i.e., anxious mood, tension, fear, insomnia, etc.) rated on a 5-point scale from 0 (not present) to 4 (severe) with a total score range from 0 to 56. Higher scores indicate greater severity of symptoms.
Clinical Global Impression - Severity scale (CGI-S) score [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 3.3  (1.21) 
[1] The CGI-S assesses the clinician’s impression of the subject’s current state of mental illness and consists of one question for the investigator: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" which is rated on a seven-point scale (1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill). Higher scores indicate greater severity of illness.


  Outcome Measures
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1.  Primary:   Number of Participants With Treatment-Emergent Adverse Events at a Frequency Threshold of ≥5%   [ Time Frame: Over the 52 week period ]

2.  Primary:   Number of Participants With Serious Treatment-Emergent Adverse Events   [ Time Frame: Over the 52 week period ]

3.  Primary:   Treatment-Emergent Adverse Events Leading to Study Discontinuation   [ Time Frame: Over the 52 week period ]

4.  Secondary:   Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score   [ Time Frame: Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 36, 44, and 52 ]

5.  Secondary:   Change From Baseline in the Hamilton Anxiety Scale (HAM-A) Total Score   [ Time Frame: Baseline and Weeks 4, 24, and 52 ]

6.  Secondary:   Change From Baseline in Clinical Global Impression Scale-Severity of Illness (CGI-S)   [ Time Frame: Baseline and Weeks 4, 24, and 52 ]

7.  Secondary:   Change From Baseline in Sheehan Disability Scale (SDS) Total Score   [ Time Frame: Baseline and Weeks 12, 24, 36, and 52 ]

8.  Secondary:   Change From Baseline in SDS Work/School Subscale   [ Time Frame: Baseline and Weeks 12, 24, 36, and 52 ]

9.  Secondary:   Change From Baseline in SDS Social Life Subscale   [ Time Frame: Baseline and Weeks 12, 24, 36, and 52 ]

10.  Secondary:   Change From Baseline in SDS Family Life/Home Responsibilities Subscale   [ Time Frame: Baseline and Weeks 12, 24, 36, and 52 ]


  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: Medical Director, Clinical Science
Organization: Takeda
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com



Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01152996     History of Changes
Other Study ID Numbers: LuAA21004_314
U1111-1115-4927 ( Registry Identifier: WHO )
First Submitted: June 28, 2010
First Posted: June 29, 2010
Results First Submitted: April 29, 2014
Results First Posted: May 28, 2014
Last Update Posted: October 12, 2017