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

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ClinicalTrials.gov Identifier: NCT00759395
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : November 8, 2012
Last Update Posted : November 8, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Anxious Major Depressive Disorder
Interventions: Drug: AZD2327
Drug: Placebo

  Participant Flow


  Baseline Characteristics

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.
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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 
Overall Participants Analyzed 
[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

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 ]

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

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