We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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):

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

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

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 
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 ]
  Hide Outcome Measure 3

Measure Type Secondary
Measure Title Psychic Anxiety Item of the Hamilton Rating Scale for Depression (HAM-D).
Measure Description

Psychic anxiety item of the Hamilton Rating Scale for Depression (HAM-D) (item 10, 0-4 units), 0 is considered the best outcome.

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 Week 4  

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 
Participants Analyzed 
[Units: Participants]
 13   9 
Psychic Anxiety Item of the Hamilton Rating Scale for Depression (HAM-D). 
[Units: Units on a scale]
Least Squares Mean (Standard Error)
 1.373  (0.313)   2.128  (0.379) 

No statistical analysis provided for Psychic Anxiety Item of the Hamilton Rating Scale for Depression (HAM-D).



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
No text entered.


  More Information