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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01288079
First received: January 26, 2011
Last updated: November 14, 2012
Last verified: November 2012
Results First Received: August 7, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, 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  
Number of Participants  
[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  
Montgomery-Asberg Depression Rating Scale (MADRS) total score at randomization [2]
[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 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.
[2] 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


  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.


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
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.  


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


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01288079     History of Changes
Other Study ID Numbers: D4131C00001
Study First Received: January 26, 2011
Results First Received: August 7, 2012
Last Updated: November 14, 2012
Health Authority: Estonia: The State Agency of Medicine
Finland: Finnish Medicines Agency
India: Drugs Controller General of India
Japan: Pharmaceuticals and Medical Devices Agency
United States: Food and Drug Administration