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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
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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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
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 ]

2.  Primary:   Hamilton Rating Scale for Anxiety (HAM-A) Total Score.   [ Time Frame: Week 4 ]

3.  Secondary:   Psychic Anxiety Item of the Hamilton Rating Scale for Depression (HAM-D).   [ Time Frame: Week 4 ]

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 ]
  Hide Outcome Measure 4

Measure Type Secondary
Measure Title The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Depression (HAM-D)Total Score.
Measure Description

Hamilton Rating Scale for Depression (HAM-D) response is defined as a >= 50% reduction from randomization (baseline) in HAM-D total score.

Hamilton Rating Scale for Depression (HAM-D)is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression.

Time Frame Randomization to 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  
The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Depression (HAM-D)Total Score.  
[units: Participants]
  5     4  

No statistical analysis provided for The Number of Participants With at Least 50% Reduction of Hamilton Rating Scale for Depression (HAM-D)Total Score.



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 ]


  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