ClinicalTrials.gov
ClinicalTrials.gov Menu

AZD7268 Safety and Tolerability Study

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: NCT01020799
Recruitment Status : Completed
First Posted : November 26, 2009
Results First Posted : April 10, 2012
Last Update Posted : April 17, 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: AZD7268
Drug: Escitalopram
Drug: Placebo capsules
Drug: Placebo tablets
Enrollment 247

Recruitment Details 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 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.
Arm/Group Title AZD7268 Placebo Escitalopram
Hide Arm/Group Description AZD7268 15 mg twice per day (BID), placebo matching escitalopram Placebo matching both AZD7268 and escitalopram Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
Period Title: Overall Study
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
Reason Not Completed
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
Arm/Group Title AZD7268 Placebo Escitalopram Total
Hide Arm/Group Description AZD7268 15 mg twice per day (BID), placebo matching escitalopram Placebo matching both AZD7268 and escitalopram Escitalopram 20 mg once per day(QD) Placebo matching AZD7268 Total of all reporting groups
Overall Number of Baseline Participants 98 99 50 247
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 98 participants 99 participants 50 participants 247 participants
39.29  (11.63) 41.77  (10.02) 36.22  (11.29) 39.09  (10.98)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 99 participants 50 participants 247 participants
Female
37
  37.8%
49
  49.5%
22
  44.0%
108
  43.7%
Male
61
  62.2%
50
  50.5%
28
  56.0%
139
  56.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 98 participants 99 participants 50 participants 247 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] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 98 participants 99 participants 50 participants 247 participants
30.9  (3.9) 31.4  (4.2) 30.8  (4.0) 31.03  (4.03)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 98 participants 99 participants 50 participants 247 participants
24.3  (2.9) 24.6  (2.8) 24.4  (2.8) 24.43  (2.83)
[1]
Measure Description: 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)]
1.Primary Outcome
Title Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score Change From Baseline to Week 4.
Hide Description 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). Change from baseline was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]
Time Frame Baseline, Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD7268 Placebo Escitalopram
Hide Arm/Group Description:
AZD7268 15 mg twice per day (BID), placebo matching escitalopram
Placebo matching both AZD7268 and escitalopram
Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
Overall Number of Participants Analyzed 91 94 49
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-11.78  (1.13) -11.45  (1.05) -11.70  (1.57)
2.Secondary Outcome
Title Montgomery-Åsberg Depression Rating Scale (MADRS) Response
Hide Description Number of patients with MADRS response at Week 4. MADRS response is defined as >=50% reduction in MADRS total score from baseline. 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). MADRS response at Week 4 is calculated using last observation carried forward (LOCF). [Full Analysis Set (FAS)]
Time Frame Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD7268 Placebo Escitalopram
Hide Arm/Group Description:
AZD7268 15 mg twice per day (BID), placebo matching escitalopram
Placebo matching both AZD7268 and escitalopram
Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
Overall Number of Participants Analyzed 91 94 49
Measure Type: Number
Unit of Measure: Participants
31 31 14
3.Secondary Outcome
Title Montgomery-Åsberg Depression Rating Scale (MADRS) Remission
Hide Description Number of patients, who achieved MADRS remission at week 4. Remission is defined as a MADRS total score <= 10. 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). MADRS remission at Week 4 is calculated using last observation carried forward (LOCF). [Full Analysis Set (FAS)]
Time Frame Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD7268 Placebo Escitalopram
Hide Arm/Group Description:
AZD7268 15 mg twice per day (BID), placebo matching escitalopram
Placebo matching both AZD7268 and escitalopram
Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
Overall Number of Participants Analyzed 91 94 49
Measure Type: Number
Unit of Measure: Participants
20 12 10
4.Secondary Outcome
Title Hamilton Rating Scale for Depression (HAM-D) Total Score Change From Baseline to Week 4.
Hide Description 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). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]
Time Frame Baseline, Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD7268 Placebo Escitalopram
Hide Arm/Group Description:
AZD7268 15 mg twice per day (BID), placebo matching escitalopram
Placebo matching both AZD7268 and escitalopram
Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
Overall Number of Participants Analyzed 91 94 49
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-9.22  (0.82) -9.15  (0.81) -9.84  (0.99)
5.Secondary Outcome
Title Clinical Global Impression - Severity (CGI-S) Score Change From Baseline
Hide Description CGI-S assesses global illness severity, i.e. the patient’s current clinical state, on a continuous scale from 1 (“Normal, not ill”) to 7 (“Among the most extremely ill patients”). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]
Time Frame Baseline, Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD7268 Placebo Escitalopram
Hide Arm/Group Description:
AZD7268 15 mg twice per day (BID), placebo matching escitalopram
Placebo matching both AZD7268 and escitalopram
Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
Overall Number of Participants Analyzed 91 94 49
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-1.26  (0.13) -1.15  (0.13) -1.31  (0.17)
6.Secondary Outcome
Title Hamilton Rating Scale for Anxiety (HAM-A) Total Score Change From Baseline
Hide Description HAM-A total score, sum of 14 item scores (each on a 0 to 4 scale), assesses the severity of anxiety symptoms on a continuous scale from 0 (the best) to 52 (the worst). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]
Time Frame Baseline, Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD7268 Placebo Escitalopram
Hide Arm/Group Description:
AZD7268 15 mg twice per day (BID), placebo matching escitalopram
Placebo matching both AZD7268 and escitalopram
Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
Overall Number of Participants Analyzed 91 94 49
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
-5.30  (0.60) -4.66  (0.61) -6.15  (0.78)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AZD7268 Placebo Escitalopram
Hide Arm/Group Description AZD7268 15 mg twice per day (BID), placebo matching escitalopram Placebo matching both AZD7268 and escitalopram Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
All-Cause Mortality
AZD7268 Placebo Escitalopram
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AZD7268 Placebo Escitalopram
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/96 (0.00%)   0/99 (0.00%)   0/50 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AZD7268 Placebo Escitalopram
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   36/96 (37.50%)   33/99 (33.33%)   26/50 (52.00%) 
Gastrointestinal disorders       
Diarrhoea  1  4/96 (4.17%)  4/99 (4.04%)  7/50 (14.00%) 
Nausea  1  3/96 (3.13%)  4/99 (4.04%)  7/50 (14.00%) 
Dry Mouth  1  15/96 (15.63%)  9/99 (9.09%)  3/50 (6.00%) 
General disorders       
Fatigue  1  5/96 (5.21%)  1/99 (1.01%)  1/50 (2.00%) 
Infections and infestations       
Nasopharyngitis  1  3/96 (3.13%)  5/99 (5.05%)  3/50 (6.00%) 
Upper Respiratory Tract Infection  1  3/96 (3.13%)  3/99 (3.03%)  3/50 (6.00%) 
Nervous system disorders       
Headache  1  9/96 (9.38%)  15/99 (15.15%)  7/50 (14.00%) 
Somnolence  1  4/96 (4.17%)  5/99 (5.05%)  3/50 (6.00%) 
Psychiatric disorders       
Libido Decreased  1  0/96 (0.00%)  1/99 (1.01%)  3/50 (6.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
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 the publication of the first multi-center publication and the second anniversary of the completion of the multi-center study at all sites. Sponsor must receive a copy of proposed manuscript for review and comment at least 60 days prior to its submission for publication or presentation.
Results Point of Contact
Name/Title: Gerard Lynch
Organization: AstraZeneca
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