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Trial record 12 of 15 for:    "Depressive Disorder" [DISEASE] AND Behavioral | ( Map: Latvia )

Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment

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ClinicalTrials.gov Identifier: NCT01838681
Recruitment Status : Completed
First Posted : April 24, 2013
Results First Posted : August 9, 2017
Last Update Posted : August 9, 2017
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
H. Lundbeck A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: Placebo
Drug: Brexpiprazole
Drug: ADT
Enrollment 1986
Recruitment Details 1986 patients were enrolled; 1982 received open-label ADT plus double-blind placebo in the 8-week Period A. In the 24-week Period B, 886 patients were randomised and 885 were treated with open-label ADT plus double-blind brexpiprazole or placebo. Non-randomised patients continued in Period A+ and received open-label ADT plus double-blind placebo.
Pre-assignment Details  
Arm/Group Title Period A Placebo and ADT (8 Weeks) Period B Placebo and ADT (24 Weeks Randomised Treatment) Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment) Period A+ Placebo and ADT (Non-randomised Patients)
Hide Arm/Group Description

Placebo adjunct to open-label treatment with ADT

Placebo: Once daily, tablets, orally

Placebo adjunct to open-label treatment with ADT (same ADT as in Period A)

Placebo: Once daily, tablets, orally

Brexpiprazole adjunct to open-label treatment with ADT (same ADT as in Period A)

Brexpiprazole: flexible dose; 1, 2, or 3 mg/day, once daily, tablets, orally

Placebo adjunct to open-label treatment with ADT (same ADT as in Period A)

Placebo: Once daily, tablets, orally

Period Title: Period A
Started 1986 0 0 0
Completed 1661 0 0 0
Not Completed 325 0 0 0
Reason Not Completed
Adverse Event             39             0             0             0
Lack of Efficacy             21             0             0             0
Early response             148             0             0             0
Withdrawal by Subject             70             0             0             0
Protocol Violation             16             0             0             0
Non-compliance with IMP             6             0             0             0
Lost to Follow-up             4             0             0             0
Withdrawal before treatment             4             0             0             0
Administrative or other reasons             17             0             0             0
Period Title: Period B/A+
Started 0 442 444 770
Completed 0 380 349 653
Not Completed 0 62 95 117
Reason Not Completed
Adverse Event             0             13             27             16
Lack of Efficacy             0             9             11             6
Withdrawal by Subject             0             28             35             47
Protocol Violation             0             1             4             6
Non-compliance with IMP             0             2             3             3
Lost to Follow-up             0             2             5             11
Withdrawal before treatment             0             1             0             0
Administrative or other reasons             0             6             10             28
Arm/Group Title All Enrolled Patients
Hide Arm/Group Description Period A
Overall Number of Baseline Participants 1986
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1986 participants
47.3  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1986 participants
Female
1402
  70.6%
Male
584
  29.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1986 participants
American Indian or Alaska Native
0
   0.0%
Asian
3
   0.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
19
   1.0%
White
1918
  96.6%
More than one race
0
   0.0%
Unknown or Not Reported
46
   2.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1986 participants
Russian Federation 121
Romania 15
United States 78
Ukraine 189
United Kingdom 168
Canada 30
Latvia 84
Sweden 85
Finland 136
Poland 325
Mexico 72
Bulgaria 119
Lithuania 76
Germany 325
Estonia 161
Korea, Republic of 2
1.Primary Outcome
Title Full Remission During the Randomised Treatment Period
Hide Description Full remission is defined as a Montomery and Åsberg Depression Rating Scale (MADRS) total score ≤10 and a ≥50% decrease from randomisation in MADRS total score for at least 8 consecutive weeks during randomized treatment. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). The MADRS total score is the sum of the 10 items.
Time Frame From randomisation to end of Period B (24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.
Arm/Group Title Period B Placebo and ADT (24 Weeks Randomised Treatment) Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)
Hide Arm/Group Description:

Placebo adjunct to open-label treatment with a commercially available ADT

Placebo: Once daily, tablets, orally

Brexpiprazole adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally

Overall Number of Participants Analyzed 441 444
Measure Type: Number
Unit of Measure: participants
110 95
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Period B Placebo and ADT (24 Weeks Randomised Treatment), Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2641
Comments [Not Specified]
Method Regression, Logistic
Comments Model included MADRS total score at the randomisation visit, treatment group, country, and the randomisation criteria used
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.60 to 1.15
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Full Functional Remission During the Randomised Treatment Period
Hide Description Full functional remission is defined as a Sheehan Disability Scale (SDS) total score <=6 and all SDS domain scores <=2 observed for at least 8 consecutive weeks during the randomised treatment period. The SDS assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment.
Time Frame From randomisation to end of Period B (24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.
Arm/Group Title Period B Placebo and ADT (24 Weeks Randomised Treatment) Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)
Hide Arm/Group Description:

Placebo adjunct to open-label treatment with a commercially available ADT

Placebo: Once daily, tablets, orally

Brexpiprazole adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally

Overall Number of Participants Analyzed 441 444
Measure Type: Number
Unit of Measure: participants
73 68
3.Secondary Outcome
Title Full Global Score Remission During the Randomised Treatment Period
Hide Description Full global score remission is defined as a Clinical Global Impression - Severity of Illness (CGI-S) score <=2 observed for at least 8 consecutive weeks during the randomised treatment period. The CGI-S is a 7-point scale where the clinician rates the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis, on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
Time Frame From randomisation to end of Period B (24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.
Arm/Group Title Period B Placebo and ADT (24 Weeks Randomised Treatment) Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)
Hide Arm/Group Description:

Placebo adjunct to open-label treatment with a commercially available ADT

Placebo: Once daily, tablets, orally

Brexpiprazole adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally

Overall Number of Participants Analyzed 441 444
Measure Type: Number
Unit of Measure: participants
143 121
4.Secondary Outcome
Title Total Time in Remission During the Randomised Treatment Period
Hide Description The total time the patient spends in remission during randomised treatment. Remission is defined as a MADRS total score <=10 and a >=50% decrease from randomisation in MADRS total score. Time in remission is defined as the sum of days over all periods between Period B visits where remission was obtained. The period between two visits is counted as in remission if the patient was in remission when the period started.
Time Frame From randomisation to end of Period B (24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.
Arm/Group Title Period B Placebo and ADT (24 Weeks Randomised Treatment) Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)
Hide Arm/Group Description:

Placebo adjunct to open-label treatment with a commercially available ADT

Placebo: Once daily, tablets, orally

Brexpiprazole adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally

Overall Number of Participants Analyzed 441 444
Mean (Standard Deviation)
Unit of Measure: Number of days
33.5  (46.1) 30.0  (44.3)
5.Secondary Outcome
Title Time to Full Remission During the Randomised Treatment Period
Hide Description The time from randomisation until full remission has been obtained. Full remission is defined as a MADRS total score ≤10 and a ≥50% decrease from randomisation in MADRS total score for at least 8 consecutive weeks during randomised treatment. The time to full remission was calculated using Kaplan-Meier Methods.
Time Frame From randomisation to end of Period B (24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.
Arm/Group Title Period B Placebo and ADT (24 Weeks Randomised Treatment) Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)
Hide Arm/Group Description:

Placebo adjunct to open-label treatment with a commercially available ADT

Placebo: Once daily, tablets, orally

Brexpiprazole adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally

Overall Number of Participants Analyzed 441 444
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
The median number of days to full remission was not estimable (less than 50% of the patients were in full remission).
6.Secondary Outcome
Title Full Remission Sustained During the Randomised Treatment Period
Hide Description Full remission sustained is defined as having obtained full remission and remain in remission until completion of the study. Full remission is defined as a MADRS total score ≤10 and a ≥50% decrease from randomisation in MADRS total score for at least 8 consecutive weeks during randomised treatment.
Time Frame From randomisation to end of Period B (24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.
Arm/Group Title Period B Placebo and ADT (24 Weeks Randomised Treatment) Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)
Hide Arm/Group Description:

Placebo adjunct to open-label treatment with a commercially available ADT

Placebo: Once daily, tablets, orally

Brexpiprazole adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally

Overall Number of Participants Analyzed 441 444
Measure Type: Number
Unit of Measure: participants
105 84
7.Secondary Outcome
Title Change From Randomisation to Week 6 in MADRS Total Score During the Randomised Treatment Period
Hide Description The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). The MADRS total score is the sum of the 10 items.
Time Frame From randomisation to week 6
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.
Arm/Group Title Period B Placebo and ADT (24 Weeks Randomised Treatment) Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)
Hide Arm/Group Description:

Placebo adjunct to open-label treatment with a commercially available ADT

Placebo: Once daily, tablets, orally

Brexpiprazole adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally

Overall Number of Participants Analyzed 422 422
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-5.9  (0.4) -6.3  (0.4)
8.Secondary Outcome
Title Change From Randomisation to Week 24 in MADRS Total Score During the Randomised Treatment Period
Hide Description The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). The MADRS total score is the sum of the 10 items.
Time Frame From randomisation to end of Period B (24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.
Arm/Group Title Period B Placebo and ADT (24 Weeks Randomised Treatment) Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)
Hide Arm/Group Description:

Placebo adjunct to open-label treatment with a commercially available ADT

Placebo: Once daily, tablets, orally

Brexpiprazole adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally

Overall Number of Participants Analyzed 361 333
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-12.6  (0.6) -11.5  (0.6)
9.Secondary Outcome
Title Response at Week 6 During the Randomised Treatment Period
Hide Description Response is defined as a >=50% decrease from randomisation in MADRS total score.
Time Frame From randomisation to week 6
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B. Last Observation Carried Forward (LOCF).
Arm/Group Title Period B Placebo and ADT (24 Weeks Randomised Treatment) Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)
Hide Arm/Group Description:

Placebo adjunct to open-label treatment with a commercially available ADT

Placebo: Once daily, tablets, orally

Brexpiprazole adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally

Overall Number of Participants Analyzed 440 442
Measure Type: Number
Unit of Measure: participants
76 82
10.Secondary Outcome
Title Response at Week 24 During the Randomised Treatment Period
Hide Description Response is defined as a >=50% decrease from randomisation in MADRS total score.
Time Frame From randomisation to end of Period B (24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B. Last Observation Carried Forward (LOCF).
Arm/Group Title Period B Placebo and ADT (24 Weeks Randomised Treatment) Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)
Hide Arm/Group Description:

Placebo adjunct to open-label treatment with a commercially available ADT

Placebo: Once daily, tablets, orally

Brexpiprazole adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally

Overall Number of Participants Analyzed 440 442
Measure Type: Number
Unit of Measure: participants
236 223
11.Secondary Outcome
Title Remission at Week 6 During the Randomised Treatment Period
Hide Description Remission is defined as a MADRS total score <=10 and a >=50% decrease from randomisation in MADRS total score.
Time Frame From randomisation to week 6
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B. Last Observation Carried Forward (LOCF).
Arm/Group Title Period B Placebo and ADT (24 Weeks Randomised Treatment) Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)
Hide Arm/Group Description:

Placebo adjunct to open-label treatment with a commercially available ADT

Placebo: Once daily, tablets, orally

Brexpiprazole adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally

Overall Number of Participants Analyzed 440 442
Measure Type: Number
Unit of Measure: participants
46 53
12.Secondary Outcome
Title Remission at Week 24 in the Randomised Treatment Period
Hide Description Remission is defined as a MADRS total score <=10 and a >=50% decrease from randomisation in MADRS total score.
Time Frame From randomisation to end of Period B (24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B. Last Observation Carried Forward (LOCF).
Arm/Group Title Period B Placebo and ADT (24 Weeks Randomised Treatment) Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)
Hide Arm/Group Description:

Placebo adjunct to open-label treatment with a commercially available ADT

Placebo: Once daily, tablets, orally

Brexpiprazole adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally

Overall Number of Participants Analyzed 440 442
Measure Type: Number
Unit of Measure: participants
198 176
13.Secondary Outcome
Title Change From Randomisation to Week 6 in SDS Total Score During the Randomised Treatment Period
Hide Description The SDS assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment.
Time Frame From randomisation to week 6
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B
Arm/Group Title Period B Placebo and ADT (24 Weeks Randomised Treatment) Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)
Hide Arm/Group Description:

Placebo adjunct to open-label treatment with a commercially available ADT

Placebo: Once daily, tablets, orally

Brexpiprazole adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally

Overall Number of Participants Analyzed 422 421
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.0  (0.3) -2.9  (0.3)
14.Secondary Outcome
Title Change From Randomisation to Week 24 in SDS Total Score During the Randomised Treatment Period
Hide Description The SDS assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment.
Time Frame From randomisation to end of Period B (24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.
Arm/Group Title Period B Placebo and ADT (24 Weeks Randomised Treatment) Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)
Hide Arm/Group Description:

Placebo adjunct to open-label treatment with a commercially available ADT

Placebo: Once daily, tablets, orally

Brexpiprazole adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally

Overall Number of Participants Analyzed 361 333
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-6.7  (0.5) -5.5  (0.5)
15.Secondary Outcome
Title Change From Randomisation to Week 6 in CGI-S Score During the Randomised Treatment Period
Hide Description The CGI-S is a 7-point scale where the clinician rates the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
Time Frame From randomisation to week 6
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.
Arm/Group Title Period B Placebo and ADT (24 Weeks Randomised Treatment) Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)
Hide Arm/Group Description:

Placebo adjunct to open-label treatment with a commercially available ADT

Placebo: Once daily, tablets, orally

Brexpiprazole adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally

Overall Number of Participants Analyzed 422 422
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.8  (0.1) -0.8  (0.1)
16.Secondary Outcome
Title Change From Randomisation to Week 24 in CGI-S Score During the Randomised Treatment Period
Hide Description The CGI-S is a 7-point scale where the clinician rates the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
Time Frame From randomisation to end of Period B (24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.
Arm/Group Title Period B Placebo and ADT (24 Weeks Randomised Treatment) Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)
Hide Arm/Group Description:

Placebo adjunct to open-label treatment with a commercially available ADT

Placebo: Once daily, tablets, orally

Brexpiprazole adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally

Overall Number of Participants Analyzed 361 333
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.7  (0.1) -1.5  (0.1)
17.Secondary Outcome
Title Change From Randomisation to Week 6 in Q-LES-Q (SF) Total Score During the Randomised Treatment Period
Hide Description The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. The Q-LES-Q short form (SF) contains 16 items from the general activities section. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good). The total score is the sum of the first 14 items. The last two scores are stand-alone items. The total score ranges from 14 to 70.
Time Frame From randomisation to week 6
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.
Arm/Group Title Period B Placebo and ADT (24 Weeks Randomised Treatment) Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)
Hide Arm/Group Description:

Placebo adjunct to open-label treatment with a commercially available ADT

Placebo: Once daily, tablets, orally

Brexpiprazole adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally

Overall Number of Participants Analyzed 422 421
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
3.5  (0.4) 3.2  (0.4)
18.Secondary Outcome
Title Change From Randomisation to Week 24 in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q (SF)) Total Score During the Randomised Treatment Period
Hide Description The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. The Q-LES-Q short form (SF) contains 16 items from the general activities section. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good). The total score is the sum of the first 14 items. The last two scores are stand-alone items. The total score ranges from 14 to 70.
Time Frame From randomisation to end of Period B (24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.
Arm/Group Title Period B Placebo and ADT (24 Weeks Randomised Treatment) Period B Brexpiprazole and ADT (24 Weeks Randomised Treatment)
Hide Arm/Group Description:

Placebo adjunct to open-label treatment with a commercially available ADT

Placebo: Once daily, tablets, orally

Brexpiprazole adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally

Overall Number of Participants Analyzed 361 333
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
7.7  (0.7) 6.2  (0.7)
Time Frame Randomisation to end of study (28 weeks)
Adverse Event Reporting Description Treatment-Emergent Adverse Events are reported in this section
 
Arm/Group Title Placebo and ADT Brexpiprazole and ADT
Hide Arm/Group Description

Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)

Placebo: Once daily, tablets, orally

Brexpiprazole adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 1, 2, 3, mg/day, once daily, tablets, orally

All-Cause Mortality
Placebo and ADT Brexpiprazole and ADT
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo and ADT Brexpiprazole and ADT
Affected / at Risk (%) Affected / at Risk (%)
Total   13/441 (2.95%)   9/444 (2.03%) 
Gastrointestinal disorders     
Pancreatitis  1  0/441 (0.00%)  1/444 (0.23%) 
Infections and infestations     
Influenza  1  1/441 (0.23%)  0/444 (0.00%) 
Injury, poisoning and procedural complications     
Forearm fracture  1  1/441 (0.23%)  0/444 (0.00%) 
Intentional overdose  1  2/441 (0.45%)  0/444 (0.00%) 
Radius fracture  1  0/441 (0.00%)  1/444 (0.23%) 
Investigations     
False positive investigation result  1  1/441 (0.23%)  0/444 (0.00%) 
Metabolism and nutrition disorders     
Obesity  1  0/441 (0.00%)  1/444 (0.23%) 
Nervous system disorders     
Dizziness  1  0/441 (0.00%)  1/444 (0.23%) 
Loss of consciousness  1  0/441 (0.00%)  1/444 (0.23%) 
Ruptured cerebral aneurysm  1  1/441 (0.23%)  0/444 (0.00%) 
Sciatica  1  1/441 (0.23%)  0/444 (0.00%) 
Seizure  1  0/441 (0.00%)  1/444 (0.23%) 
Psychiatric disorders     
Major depression  1  1/441 (0.23%)  1/444 (0.23%) 
Self injurious behaviour  1  1/441 (0.23%)  0/444 (0.00%) 
Suicidal ideation  1  3/441 (0.68%)  2/444 (0.45%) 
Suicide attempt  1  1/441 (0.23%)  0/444 (0.00%) 
Reproductive system and breast disorders     
Ovarian cyst  1  1/302 (0.33%)  0/307 (0.00%) 
Social circumstances     
Family stress  1  0/441 (0.00%)  1/444 (0.23%) 
Vascular disorders     
Circulatory collapse  1  0/441 (0.00%)  1/444 (0.23%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo and ADT Brexpiprazole and ADT
Affected / at Risk (%) Affected / at Risk (%)
Total   97/441 (22.00%)   108/444 (24.32%) 
Infections and infestations     
Nasopharyngitis  1  34/441 (7.71%)  28/444 (6.31%) 
Injury, poisoning and procedural complications     
Accidental overdose  1  25/441 (5.67%)  27/444 (6.08%) 
Investigations     
Weight increased  1  22/441 (4.99%)  42/444 (9.46%) 
Nervous system disorders     
Headache  1  31/441 (7.03%)  34/444 (7.66%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Email contact via
Organization: H. Lundbeck A/S
EMail: LundbeckClinicalTrials@lundbeck.com
Layout table for additonal information
Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01838681     History of Changes
Other Study ID Numbers: 14570A
2012-001380-76 ( EudraCT Number )
First Submitted: April 20, 2013
First Posted: April 24, 2013
Results First Submitted: June 8, 2017
Results First Posted: August 9, 2017
Last Update Posted: August 9, 2017