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Study of Antidepressant Efficacy of a Selective, High Affinity Enkephalinergic Agonist in Anxious Major Depressive Disorder (AMDD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00759395
First received: September 24, 2008
Last updated: October 10, 2012
Last verified: October 2012
History of Changes
Results First Received: October 10, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Anxious Major Depressive Disorder
Interventions: Drug: AZD2327
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
A single site, randomized, double blind, placebo-controlled, parallel group experimental study. Patients recruited between November 2008 and October 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening for eligibility and wash-out of restricted medications.

Reporting Groups
  Description
AZD2327 AZD2327 3mg BID Tablet, Oral, Daily
Placebo Placebo BID, Tablet, Oral, Daily

Participant Flow:   Overall Study
    AZD2327     Placebo  
STARTED     13     9  
COMPLETED     11     7  
NOT COMPLETED     2     2  
Adverse Event                 1                 0  
Withdrawal by Subject                 1                 0  
Lack of Efficacy                 0                 2  



  Baseline Characteristics
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Reporting Groups
  Description
AZD2327 AZD2327 3mg BID Tablet, Oral, Daily
Placebo Placebo BID, Tablet, Oral, Daily
Total Total of all reporting groups

Baseline Measures
    AZD2327     Placebo     Total  
Number of Participants  
[units: participants]
 		  13     9     22  
Age  
[units: Years]
Mean ± Standard Deviation 		  40  ± 12.2     48.7  ± 11.3     44.35  ± 11.75  
Gender  
[units: Participants]
 		     
Female     7     5     12  
Male     6     4     10  



  Outcome Measures
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1.  Primary:   Hamilton Rating Scale for Depression (HAM-D) Total Score.   [ Time Frame: Week 4 ]
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2.  Primary:   Hamilton Rating Scale for Anxiety (HAM-A) Total Score.   [ Time Frame: Week 4 ]
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Measure Type Primary
Measure Title Hamilton Rating Scale for Anxiety (HAM-A) Total Score.
Measure Description The Hamilton Rating Scale for Anxiety (HAM-A) is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAM-A total score is the sum of the 14 items and the score ranges from 0 to 56, 0 is considered the best outcome.
Time Frame Week 4  
Safety Issue No  

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
AZD2327 AZD2327 3mg BID Tablet, Oral, Daily
Placebo Placebo BID, Tablet, Oral, Daily

Measured Values
    AZD2327     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  13     9  
Hamilton Rating Scale for Anxiety (HAM-A) Total Score.  
[units: Units on a scale]
Least Squares Mean ± Standard Error 		  13.029  ± 2.257     17.736  ± 2.712  

No statistical analysis provided for Hamilton Rating Scale for Anxiety (HAM-A) Total Score.



3.  Secondary:   Psychic Anxiety Item of the Hamilton Rating Scale for Depression (HAM-D).   [ Time Frame: Week 4 ]
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4.  Secondary:   The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Depression (HAM-D)Total Score.   [ Time Frame: Randomization to week 4 ]
  Show Outcome Measure 4

5.  Secondary:   The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Anxiety (HAM-A)Total Score.   [ Time Frame: Randomization to week 4 ]
  Show Outcome Measure 5


  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 NOT 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.


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
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00759395     History of Changes
Obsolete Identifiers: NCT00738270
Other Study ID Numbers: D0880C00021
Study First Received: September 24, 2008
Results First Received: October 10, 2012
Last Updated: October 10, 2012
Health Authority: United States: Institutional Review Board