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A Study to Assess the Effect and Safety of AZD6765 in Patients With Major Depressive Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01482221
First Posted: November 30, 2011
Last Update Posted: April 11, 2017
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.
Information provided by (Responsible Party):
AstraZeneca
Results First Submitted: October 13, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: AZD6765 iv
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
This multicenter study was conducted in Chile, Slovakia, South Africa, and the United States between 16 December 2011 and 26 August 2013. A total of 542 patients were enrolled in the study and of these, 302 patients were randomized to treatment. 240 patients were not randomized to treatment due to eligibility criteria not being fulfilled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study had a screening/washout period of up to 42 days, a 12-week double blind treatment period, and a 14-day follow-up period. Patients received 3 infusions per week during Weeks 1 to 3,1 infusion per week during Weeks 4 to 6, and 1 infusion every other week during Weeks 7 to 12.

Reporting Groups
  Description
AZD6765 50 mg Intravenous infusion
AZD6765 100 mg Intravenous infusion
Placebo Intravenous infusion

Participant Flow:   Overall Study
    AZD6765 50 mg   AZD6765 100 mg   Placebo
STARTED   101   101   100 
COMPLETED   80   81   77 
NOT COMPLETED   21   20   23 
Lack of Efficacy                1                0                1 
Lost to Follow-up                3                2                1 
Study-Specific Withdrawal Criteria                2                0                1 
Condition under Investigation Worsened                3                2                4 
Severe Non-Compliance to Protocol                1                0                1 
Adverse Event                1                7                3 
Withdrawal by Subject                10                7                12 
Incorrect randomization                0                1                0 
Physician Decision                0                1                0 



  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
AZD6765 50 mg Intravenous infusion
AZD6765 100 mg Intravenous infusion
Placebo Intravenous infusion
Total Total of all reporting groups

Baseline Measures
   AZD6765 50 mg   AZD6765 100 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 101   101   100   302 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.7  (11.19)   47.5  (11.89)   49.5  (11.12)   48.2  (11.40) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      62  61.4%      70  69.3%      65  65.0%      197  65.2% 
Male      39  38.6%      31  30.7%      35  35.0%      105  34.8% 
Race/Ethnicity, Customized 
[Units: Participants]
       
White   91   87   91   269 
Black or African American   8   11   6   25 
Asian   0   3   1   4 
Other   2   0   2   4 


  Outcome Measures
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1.  Primary:   Change From Baseline to Week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score   [ Time Frame: Baseline to Week 6 ]

2.  Secondary:   Change From Baseline to Week 12 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score   [ Time Frame: Baseline to Week 12 ]

3.  Secondary:   Percentage of Patients With Sustained Response From Week 6 to Week 12 (Defined as ≥50% Reduction From Baseline in the MADRS Total Score at Week 6 and Which is Maintained Through Week 12)   [ Time Frame: Week 6 to Week 12 ]

4.  Secondary:   Percentage of Patients Who Were Responders (Defined as a ≥50% Reduction From Baseline in MADRS Total Score) at Week 6   [ Time Frame: Baseline to Week 6 ]

5.  Secondary:   Percentage of Patients Who Were Responders (Defined as a ≥50% Reduction From Baseline in MADRS Total Score) at Week 12   [ Time Frame: Baseline to Week 12 ]

6.  Secondary:   Percentage of Patients Who Were Remitted (Defined as MADRS Total Score ≤10) at Week 6   [ Time Frame: Baseline to Week 6 ]

7.  Secondary:   Percentage of Patients Who Were Remitted (Defined as MADRS Total Score ≤10) at Week 12   [ Time Frame: Baseline to Week 12 ]

8.  Secondary:   Change From Baseline in Functional Impairment as Measured by the Change From Baseline in the Sheehan Disability Scale (SDS) Total Score   [ Time Frame: Baseline to Week 12 ]

9.  Secondary:   Change in Severity of Depressive Symptoms as Measured by Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score   [ Time Frame: Baseline to Week 12 ]

10.  Secondary:   Change in Severity of Depressive Symptoms as Measured by the CGI-I Response (Defined as CGI-I Rating of “Very Much Improved” or “Much Improved”) at Week 6   [ Time Frame: Baseline to Week 6 ]

11.  Secondary:   Change in Severity of Depressive Symptoms as Measured by the CGI-I Response (Defined as CGI-I Rating of “Very Much Improved” or “Much Improved”) at Week 12   [ Time Frame: Baseline to Week 12 ]

12.  Secondary:   Change From Baseline in Self-rated Severity of Depressive Symptoms as Measured by Quick Inventory of Depressive Symptomatology Self-Rated 16-item Scale (QIDS-SR-16) Total Score   [ Time Frame: Baseline to Week 12 ]


  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
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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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Sanjeev Pathak
Organization: AstraZeneca
e-mail: ClinicalTrialTransparency@astrazeneca.com



Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01482221     History of Changes
Other Study ID Numbers: D6702C00031
EudraCT number 2011-004690-87
First Submitted: November 28, 2011
First Posted: November 30, 2011
Results First Submitted: October 13, 2014
Results First Posted: April 11, 2017
Last Update Posted: April 11, 2017