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A Study to Assess the Safety and Effect of TC-5214 in Patients With Major Depressive Disorder.

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01288079
First Posted: February 2, 2011
Last Update Posted: November 20, 2012
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):
AstraZeneca
Results First Submitted: August 7, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: TC-5214
Drug: Duloxetine
Drug: Placebo

  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
This multicenter study was conducted in Europe, Asia, and North America between 4 February 2011 and 26 April 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
21-day screening/washout and 8-week prospective open-label SSRI(selective serotonin reuptake inhibitors)/SNRI(selective serotonin and norepinephrine reuptake inhibitors) periods to identify population of inadequate responders(<50% reduction in Hamilton Rating Scale for Depression total score of ≥16 and a Clinical Global Impression-Severity ≥4).

Reporting Groups
  Description
1 mg BID TC-5214 No text entered.
4 mg BID TC-5214 No text entered.
60 mg QD Duloxetine No text entered.
Placebo No text entered.

Participant Flow:   Overall Study
    1 mg BID TC-5214   4 mg BID TC-5214   60 mg QD Duloxetine   Placebo
STARTED   37   36   37   35 
COMPLETED   17   9   18   18 
NOT COMPLETED   20   27   19   17 
Withdrawal by Subject                2                4                1                0 
Adverse Event                2                1                2                3 
Severe Non-Compliance to Protocol                1                3                1                3 
Condition under Investigation Worsened                0                0                0                1 
Lack of Efficacy                2                2                0                2 
Study-Specific Withdrawal Criteria                1                1                0                0 
Lost to Follow-up                1                1                1                0 
Other or Study Termination                11                15                14                8 



  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
1 mg BID TC-5214 No text entered.
4 mg BID TC-5214 No text entered.
60 mg QD Duloxetine No text entered.
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
   1 mg BID TC-5214   4 mg BID TC-5214   60 mg QD Duloxetine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 37   36   37   35   145 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.5  (13.03)   40.3  (12.50)   41.8  (12.70)   40.1  (10.49)   41.7  (12.24) 
Gender 
[Units: Participants]
         
Female   24   26   22   19   91 
Male   13   10   15   16   54 
Race/Ethnicity, Customized 
[Units: Participants]
         
White   23   20   23   20   86 
Black or African American   1   4   4   5   14 
Asian   12   10   9   9   40 
Native Hawaiian or other Pacific Islander   0   0   0   0   0 
American Indian or Alaska Native   0   0   0   0   0 
Other   1   2   1   1   5 
Hamilton Rating Scale for Depression-17 items (HAMD-17) total score at randomization [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 20.914  (3.425)   21.371  (3.606)   21.857  (3.499)   21.344  (4.100)   21.372  (3.632) 
[1] A 17-item, clinician-rated scale that assesses depressive symptoms. The Hamilton Rating Scale for Depression-17 items (HAMD-17) consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. Higher HAMD-17 scores indicate more severe depression.
Montgomery-Asberg Depression Rating Scale (MADRS) total score at randomization [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 27.228  (5.202)   26.857  (5.542)   28.600  (6.796)   27.625  (5.320)   27.577  (5.734) 
[1] A 10-item scale for the evaluation of depressive symptoms. Each Montgomery-Asberg Depression Rating Scale (MADRS) item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.


  Outcome Measures

1.  Primary:   Change in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score From Randomization to End of Treatment   [ Time Frame: Randomization (Week 8) to end of treatment (Week 16) ]


  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
The study was terminated early and thus only a fraction of the planned number of patients were randomized and many did not complete the study. As a consequence the possibility of interpreting efficacy over an 8 week period is considerably reduced.


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com



Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01288079     History of Changes
Other Study ID Numbers: D4131C00001
First Submitted: January 26, 2011
First Posted: February 2, 2011
Results First Submitted: August 7, 2012
Results First Posted: October 29, 2012
Last Update Posted: November 20, 2012