We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01020799
Previous Study | Return to List | Next Study

AZD7268 Safety and Tolerability Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01020799
First Posted: November 26, 2009
Last Update Posted: April 17, 2012
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: January 11, 2012  
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: AZD7268
Drug: Escitalopram
Drug: Placebo capsules
Drug: Placebo tablets

  Participant Flow
  Hide 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 total of 18 centers were inititated with first patient enrolled on 16 November 2009 and last patient completed on 15 April 2010. A total of 430 patients were enrolled with 247 qualified patients allocated to randomized treatment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were required to discontinue current treatment for MDD at least 7 days prior to randomization (14 days prior to Day 1 for monoamine oxidase inhibitors [MAOIs] and 28 days prior to Day 1 for fluoxetine). Patients not taking medications for MDD at enrollment could be randomized once eligibility was confirmed.

Reporting Groups
  Description
AZD7268 AZD7268 15 mg twice per day (BID), placebo matching escitalopram
Placebo Placebo matching both AZD7268 and escitalopram
Escitalopram Escitalopram 20 mg once per day(QD) Placebo matching AZD7268

Participant Flow:   Overall Study
    AZD7268   Placebo   Escitalopram
STARTED   98   99   50 
Patients Received Treatment   96   99   50 
Full Analysis Set   91   94   49 
COMPLETED   79   85   43 
NOT COMPLETED   19   14   7 
Adverse Event                4                3                2 
non-compliance; lack of efficacy; etc.                4                3                0 
Protocol Violation                3                2                0 
Withdrawal by Subject                2                2                3 
Lost to Follow-up                6                4                2 



  Baseline Characteristics
  Hide 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
AZD7268 AZD7268 15 mg twice per day (BID), placebo matching escitalopram
Placebo Placebo matching both AZD7268 and escitalopram
Escitalopram Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
Total Total of all reporting groups

Baseline Measures
   AZD7268   Placebo   Escitalopram   Total 
Overall Participants Analyzed 
[Units: Participants]
 98   99   50   247 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.29  (11.63)   41.77  (10.02)   36.22  (11.29)   39.09  (10.98) 
Gender 
[Units: Participants]
       
Female   37   49   22   108 
Male   61   50   28   139 
Race/Ethnicity, Customized 
[Units: Participants]
       
White   66   56   34   156 
Black or African American   27   35   15   77 
Asian   0   4   1   5 
Native Hawaiian or other Pacific Islander   1   1   0   2 
American Indian or Alaska Native   1   0   0   1 
Other   3   3   0   6 
Montgomery-Åsberg Depression Rating Scale (MADRS) total score at baseline [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 30.9  (3.9)   31.4  (4.2)   30.8  (4.0)   31.03  (4.03) 
[1] MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]
Hamilton Rating Scale for Depression (HAM-D) total score at baseline [1] 
[Units: Scores on a scale]
Mean (Standard Deviation)
 24.3  (2.9)   24.6  (2.8)   24.4  (2.8)   24.43  (2.83) 
[1] HAM-D total score, sum of 17 item scores (each on a 0 to 2 or 0 to 4 scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 52 (the worst). [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score Change From Baseline to Week 4.   [ Time Frame: Baseline, Week 4 ]

2.  Secondary:   Montgomery-Åsberg Depression Rating Scale (MADRS) Response   [ Time Frame: Week 4 ]

3.  Secondary:   Montgomery-Åsberg Depression Rating Scale (MADRS) Remission   [ Time Frame: Week 4 ]

4.  Secondary:   Hamilton Rating Scale for Depression (HAM-D) Total Score Change From Baseline to Week 4.   [ Time Frame: Baseline, Week 4 ]

5.  Secondary:   Clinical Global Impression - Severity (CGI-S) Score Change From Baseline   [ Time Frame: Baseline, Week 4 ]

6.  Secondary:   Hamilton Rating Scale for Anxiety (HAM-A) Total Score Change From Baseline   [ Time Frame: Baseline, Week 4 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide More Information

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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


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



Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01020799     History of Changes
Other Study ID Numbers: D1151C00005
First Submitted: November 25, 2009
First Posted: November 26, 2009
Results First Submitted: January 11, 2012
Results First Posted: April 10, 2012
Last Update Posted: April 17, 2012