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6-week Study Treatment to Evaluate the Safety and Effectiveness of AZD2066 in Patients With Major Depressive Disorder

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01145755
First received: May 27, 2010
Last updated: September 27, 2012
Last verified: September 2012
History of Changes
Results First Received: August 28, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: AZD2066
Drug: Placebo
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
This study was conducted only in the United States (US). A total of 13 study centers enrolled 249 patients. First subject enrolled: 27 May 2010 Last subject last visit: 10 November 2010

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients with major depressive disorder were included.

Reporting Groups
  Description
AZD2066 AZD2066 12 mg, 18 mg
Duloxetine Duloxetine 30 mg, 60 mg
Placebo Placebo

Participant Flow:   Overall Study
    AZD2066     Duloxetine     Placebo  
STARTED     40     47     44  
COMPLETED     20     19     19  
NOT COMPLETED     20     28     25  
Adverse Event                 2                 4                 2  
Withdrawal by Subject                 2                 2                 2  
Lost to Follow-up                 2                 3                 1  
Protocol Violation                 0                 3                 1  
Study Closure                 14                 14                 17  
Lack of Efficacy                 0                 1                 0  
Patient could not swollow medication                 0                 0                 1  
Withdrawal by Subject                 0                 0                 1  
Positive urine ethanol                 0                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
AZD2066 AZD2066 12 mg, 18 mg
Duloxetine Duloxetine 30 mg, 60 mg
Placebo Placebo
Total Total of all reporting groups

Baseline Measures
    AZD2066     Duloxetine     Placebo     Total  
Number of Participants  
[units: participants]
 		  40     47     44     131  
Age  
[units: Years]
Mean ( Full Range ) 		  42.2  
  ( 21 to 60 )   		  39.9  
  ( 19 to 60 )   		  38.4  
  ( 20 to 61 )   		  40.1  
  ( 19 to 60 )  
Gender  
[units: Participants]
 		       
Female     23     24     30     77  
Male     17     23     14     54  



  Outcome Measures
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1.  Primary:   MADRS Total Score Change From Baseline to Week 6   [ Time Frame: 6 weeks ]
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2.  Secondary:   MADRS Response   [ Time Frame: 6 weeks ]
  Show Outcome Measure 2

3.  Secondary:   MADRS Remission   [ Time Frame: 6 weeks ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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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.


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: Gerard Lynch
Organization: AstraZeneca
phone: 645895 ext +44 1509
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01145755     History of Changes
Other Study ID Numbers: D0475C00020
Study First Received: May 27, 2010
Results First Received: August 28, 2012
Last Updated: September 27, 2012
Health Authority: United States: Food and Drug Administration