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6-week Study Treatment to Evaluate the Safety and Effectiveness of AZD2066 in Patients With Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT01145755
Recruitment Status : Terminated
First Posted : June 17, 2010
Results First Posted : September 27, 2012
Last Update Posted : October 3, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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: AZD2066
Drug: Placebo
Drug: Duloxetine
Enrollment 131
Recruitment Details This study was conducted only in the United States (US). A total of 13 study centers enrolled 249 patients. First subject enrolled: 27 May 2010 Last subject last visit: 10 November 2010
Pre-assignment Details Patients with major depressive disorder were included.
Arm/Group Title AZD2066 Duloxetine Placebo
Hide Arm/Group Description AZD2066 12 mg, 18 mg Duloxetine 30 mg, 60 mg Placebo
Period Title: Overall Study
Started 40 47 44
Completed 20 19 19
Not Completed 20 28 25
Reason Not Completed
Adverse Event             2             4             2
Withdrawal by Subject             2             2             2
Lost to Follow-up             2             3             1
Protocol Violation             0             3             1
Study Closure             14             14             17
Lack of Efficacy             0             1             0
Patient could not swollow medication             0             0             1
Withdrawal by Subject             0             0             1
Positive urine ethanol             0             1             0
Arm/Group Title AZD2066 Duloxetine Placebo Total
Hide Arm/Group Description AZD2066 12 mg, 18 mg Duloxetine 30 mg, 60 mg Placebo Total of all reporting groups
Overall Number of Baseline Participants 40 47 44 131
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 40 participants 47 participants 44 participants 131 participants
42.2
(21 to 60)
39.9
(19 to 60)
38.4
(20 to 61)
40.1
(19 to 60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 47 participants 44 participants 131 participants
Female
23
  57.5%
24
  51.1%
30
  68.2%
77
  58.8%
Male
17
  42.5%
23
  48.9%
14
  31.8%
54
  41.2%
1.Primary Outcome
Title MADRS Total Score Change From Baseline to Week 6
Hide Description Montgomery-Asberg Depression Rating Scale (MADRS): The MADRS is a 10-item scale for the evaluation of depressive symptoms (Montgomery et al 1979). Each MADRS item is rated on a 0 to 6 scale. Total score range from 0-60, where higher MADRS scores indicate higher levels of depressive symptoms.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD2066 Duloxetine Placebo
Hide Arm/Group Description:
AZD2066 12 mg, 18 mg
Duloxetine 30 mg, 60 mg
Placebo
Overall Number of Participants Analyzed 39 45 40
Mean (Standard Deviation)
Unit of Measure: scores on the scale
-13.1658  (2.11) -14.0271  (1.97) -14.1575  (2.16)
2.Secondary Outcome
Title MADRS Response
Hide Description A MADRS responder at week 6 is defined as a patient with a reduction of at least 50% from baseline MADRS total score.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD2066 Duloxetine Placebo
Hide Arm/Group Description:
AZD2066 12 mg, 18 mg
Duloxetine 30 mg, 60 mg
Placebo
Overall Number of Participants Analyzed 21 20 19
Measure Type: Number
Unit of Measure: Participants
9 9 9
3.Secondary Outcome
Title MADRS Remission
Hide Description A patient will be classified as in remission if their MADRS total score is ≤10 at Week 6
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD2066 Duloxetine Placebo
Hide Arm/Group Description:
AZD2066 12 mg, 18 mg
Duloxetine 30 mg, 60 mg
Placebo
Overall Number of Participants Analyzed 21 20 19
Measure Type: Number
Unit of Measure: Participants
5 8 7
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AZD2066 Duloxetine Placebo
Hide Arm/Group Description AZD2066 12 mg, 18 mg Duloxetine 30 mg, 60 mg Placebo
All-Cause Mortality
AZD2066 Duloxetine Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AZD2066 Duloxetine Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/40 (2.50%)   0/47 (0.00%)   0/44 (0.00%) 
Reproductive system and breast disorders       
Ovarian mass  1  1/40 (2.50%)  0/47 (0.00%)  0/44 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AZD2066 Duloxetine Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   21/40 (52.50%)   30/47 (63.83%)   16/44 (36.36%) 
Gastrointestinal disorders       
NAUSEA  1  6/40 (15.00%)  12/47 (25.53%)  4/44 (9.09%) 
DIARRHOEA  1  3/40 (7.50%)  10/47 (21.28%)  4/44 (9.09%) 
DRY MOUTH  1  1/40 (2.50%)  7/47 (14.89%)  4/44 (9.09%) 
CONSTIPATION  1  4/40 (10.00%)  1/47 (2.13%)  3/44 (6.82%) 
ABDOMINAL PAIN  1  2/40 (5.00%)  0/47 (0.00%)  0/44 (0.00%) 
DYSPEPSIA  1  2/40 (5.00%)  0/47 (0.00%)  0/44 (0.00%) 
General disorders       
IRRITABILITY  1  2/40 (5.00%)  0/47 (0.00%)  1/44 (2.27%) 
Infections and infestations       
UPPER RESPIRATORY TRACT INFECTION  1  4/40 (10.00%)  3/47 (6.38%)  1/44 (2.27%) 
Metabolism and nutrition disorders       
INCREASED APPETITE  1  2/40 (5.00%)  0/47 (0.00%)  1/44 (2.27%) 
Nervous system disorders       
HEADACHE  1  10/40 (25.00%)  7/47 (14.89%)  0/44 (0.00%) 
SOMNOLENCE  1  2/40 (5.00%)  5/47 (10.64%)  0/44 (0.00%) 
DIZZINESS  1  3/40 (7.50%)  3/47 (6.38%)  2/44 (4.55%) 
Psychiatric disorders       
INSOMNIA  1  4/40 (10.00%)  2/47 (4.26%)  0/44 (0.00%) 
ANXIETY  1  2/40 (5.00%)  0/47 (0.00%)  2/44 (4.55%) 
Reproductive system and breast disorders       
ERECTILE DYSFUNCTION  1  0/40 (0.00%)  5/47 (10.64%)  1/44 (2.27%) 
Skin and subcutaneous tissue disorders       
RASH  1  2/40 (5.00%)  1/47 (2.13%)  0/44 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
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.

No publication or presentation of results until the earlier of 1) the date of the first study results publication or 2) 18 months after completion or termination of the study.

AZ review 60 days prior submission and AZ has the possibility to further delay publication for an additional 90 days

Results Point of Contact
Name/Title: Gerard Lynch
Organization: AstraZeneca
Phone: 645895 ext +44 1509
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01145755     History of Changes
Other Study ID Numbers: D0475C00020
First Submitted: May 27, 2010
First Posted: June 17, 2010
Results First Submitted: August 28, 2012
Results First Posted: September 27, 2012
Last Update Posted: October 3, 2012