Back to resultsBrexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Brexpiprazole
ADT
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
- The patient is an outpatient consulting a psychiatrist.
- The patient has an MDD diagnosed according to DSM-IV-TR™. The current Major Depressive Episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI).
- The patient has a moderate to severe depression and an insufficient response to at least one and no more than three adequate antidepressant treatments.
- The patient agrees to protocol-defined use of effective contraception.
Exclusion Criteria:
- The patient has any current psychiatric disorder or Axis I disorder (DSM-IV-TR™ criteria), established as the primary diagnosis, other than MDD.
- The patient has a current Axis II (DSM-IV-TR™) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypical or histrionic personality disorder.
- The patient has experienced/experiences hallucinations, delusions or any psychotic symptomatology in the current MDE.
- The patient suffers from mental retardation, organic mental disorders, or mental disorders due to a general medical condition (DSM-IV-TR™ criteria).
- The patient, in the opinion of the investigator or according to Columbia-Suicide Severity Rating Scale (C-SSRS), is at significant risk of suicide.
- The patient has had neuroleptic malignant syndrome.
- The patient has any relevant medical history or current presence of systemic disease.
- The patient has, at the Screening Visit an abnormal ECG that is, in the investigator's opinion, clinically significant.
- The patient has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin, that has not been in remission for >5 years prior to the first dose of IMP.
- The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.
Other inclusion and exclusion criteria may apply.
Sites / Locations
- US041
- US043
- US042
- US053
- US040
- US046
- US052
- US047
- BG007
- BG002
- BG003
- BG001
- BG004
- BG005
- BG006
- CA003
- CA004
- CA001
- CA002
- CA005
- EE002
- EE003
- EE006
- EE001
- EE005
- EE004
- FI002
- FI003
- FI006
- FI001
- FI007
- FI009
- DE007
- DE014
- DE015
- DE006
- DE010
- DE012
- DE009
- DE022
- DE008
- DE017
- DE001
- DE004
- DE002
- DE016
- KR001
- KR004
- LV004
- LV005
- LV002
- LV003
- LV001
- LT006
- LT003
- LT001
- LT005
- LT002
- LT004
- MX009
- MX008
- MX003
- MX002
- PL010
- PL016
- PL017
- PL007
- PL002
- PL011
- PL018
- PL013
- PL001
- PL006
- PL014
- PL012
- PL019
- RO003
- RO006
- RO001
- RO004
- RU002
- RU004
- RU003
- RU006
- RU007
- RU010
- RU014
- RU012
- RU005
- SE008
- SE006
- SE009
- SE001
- UA006
- UA007
- UA003
- UA014
- UA002
- UA005
- UA012
- UA009
- GB003
- GB005
- GB002
- GB004
- GB001
- GB006
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Brexpiprazole
Arm Description
Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)
Brexpiprazole adjunct to open-label treatment with a commercially available ADT
Outcomes
Primary Outcome Measures
Full Remission During the Randomised Treatment Period
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.
Secondary Outcome Measures
Full Functional Remission During the Randomised Treatment Period
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.
Full Global Score Remission During the Randomised Treatment Period
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.
Total Time in Remission During the Randomised Treatment Period
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 to Full Remission During the Randomised Treatment Period
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.
Full Remission Sustained During the Randomised Treatment Period
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.
Change From Randomisation to Week 6 in MADRS Total Score During the Randomised Treatment Period
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.
Change From Randomisation to Week 24 in MADRS Total Score During the Randomised Treatment Period
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.
Response at Week 6 During the Randomised Treatment Period
Response is defined as a >=50% decrease from randomisation in MADRS total score.
Response at Week 24 During the Randomised Treatment Period
Response is defined as a >=50% decrease from randomisation in MADRS total score.
Remission at Week 6 During the Randomised Treatment Period
Remission is defined as a MADRS total score <=10 and a >=50% decrease from randomisation in MADRS total score.
Remission at Week 24 in the Randomised Treatment Period
Remission is defined as a MADRS total score <=10 and a >=50% decrease from randomisation in MADRS total score.
Change From Randomisation to Week 6 in SDS Total Score 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.
Change From Randomisation to Week 24 in SDS Total Score 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.
Change From Randomisation to Week 6 in CGI-S Score 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.
Change From Randomisation to Week 24 in CGI-S Score 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.
Change From Randomisation to Week 6 in Q-LES-Q (SF) Total Score During the Randomised Treatment Period
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.
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
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.
Full Information
NCT ID
NCT01838681
First Posted
April 20, 2013
Last Updated
July 11, 2017
Sponsor
H. Lundbeck A/S
Collaborators
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01838681
Brief Title
Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
Official Title
Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Flexible-dose Long-term Study to Evaluate the Maintenance of Efficacy and Safety of 1 to 3 mg/Day of Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
Collaborators
Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the long-term efficacy and safety of brexpiprazole as an adjunctive treatment to an antidepressant treatment (ADT) for adult patients with Major Depressive Disorder (MDD).
Detailed Description
The total duration of the study was 32 weeks and the study consisted of Periods A, B, and A+. Patients entered the study in Period A and were treated open-label with one of six commercially available antidepressant treatments (ADTs) for 8 weeks. Patients who met the blinded response criteria at the Week 6 Visit, were deemed early responders and were withdrawn from the study. At Week 8, patients with inadequate response to placebo + ADT, as per the randomisation criteria, entered Period B and were randomised to received double-blind brexpiprazole + ADT or placebo + ADT for 24 weeks. Non-randomised patients continued in Period A+ and received placebo + ADT until the end of the study. The primary objective was to compare the efficacy and safety of brexpiprazole with placebo. This comparison occurred Period B; therefore, the focus is Period B.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1986 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)
Arm Title
Brexpiprazole
Arm Type
Experimental
Arm Description
Brexpiprazole adjunct to open-label treatment with a commercially available ADT
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Once daily, tablets, orally
Intervention Type
Drug
Intervention Name(s)
Brexpiprazole
Intervention Description
1, 2, or 3 mg/day, once daily dose, tablets, orally. Uptitration in weekly steps from 1 mg/day
Intervention Type
Drug
Intervention Name(s)
ADT
Intervention Description
Duloxetine, escitalopram, fluoxetine, paroxetine IR, sertraline, venlafaxine XR; dosing according to label
Primary Outcome Measure Information:
Title
Full Remission During the Randomised Treatment Period
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)
Secondary Outcome Measure Information:
Title
Full Functional Remission During the Randomised Treatment Period
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)
Title
Full Global Score Remission During the Randomised Treatment Period
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)
Title
Total Time in Remission During the Randomised Treatment Period
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)
Title
Time to Full Remission During the Randomised Treatment Period
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)
Title
Full Remission Sustained During the Randomised Treatment Period
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)
Title
Change From Randomisation to Week 6 in MADRS Total Score During the Randomised Treatment Period
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
Title
Change From Randomisation to Week 24 in MADRS Total Score During the Randomised Treatment Period
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)
Title
Response at Week 6 During the Randomised Treatment Period
Description
Response is defined as a >=50% decrease from randomisation in MADRS total score.
Time Frame
From randomisation to week 6
Title
Response at Week 24 During the Randomised Treatment Period
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)
Title
Remission at Week 6 During the Randomised Treatment Period
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
Title
Remission at Week 24 in the Randomised Treatment Period
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)
Title
Change From Randomisation to Week 6 in SDS Total Score During the Randomised Treatment Period
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
Title
Change From Randomisation to Week 24 in SDS Total Score During the Randomised Treatment Period
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)
Title
Change From Randomisation to Week 6 in CGI-S Score During the Randomised Treatment Period
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
Title
Change From Randomisation to Week 24 in CGI-S Score During the Randomised Treatment Period
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)
Title
Change From Randomisation to Week 6 in Q-LES-Q (SF) Total Score During the Randomised Treatment Period
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
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
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient is an outpatient consulting a psychiatrist.
The patient has an MDD diagnosed according to DSM-IV-TR™. The current Major Depressive Episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI).
The patient has a moderate to severe depression and an insufficient response to at least one and no more than three adequate antidepressant treatments.
The patient agrees to protocol-defined use of effective contraception.
Exclusion Criteria:
The patient has any current psychiatric disorder or Axis I disorder (DSM-IV-TR™ criteria), established as the primary diagnosis, other than MDD.
The patient has a current Axis II (DSM-IV-TR™) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypical or histrionic personality disorder.
The patient has experienced/experiences hallucinations, delusions or any psychotic symptomatology in the current MDE.
The patient suffers from mental retardation, organic mental disorders, or mental disorders due to a general medical condition (DSM-IV-TR™ criteria).
The patient, in the opinion of the investigator or according to Columbia-Suicide Severity Rating Scale (C-SSRS), is at significant risk of suicide.
The patient has had neuroleptic malignant syndrome.
The patient has any relevant medical history or current presence of systemic disease.
The patient has, at the Screening Visit an abnormal ECG that is, in the investigator's opinion, clinically significant.
The patient has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin, that has not been in remission for >5 years prior to the first dose of IMP.
The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.
Other inclusion and exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
US041
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
US043
City
Cerritos
State/Province
California
Country
United States
Facility Name
US042
City
Temecula
State/Province
California
Country
United States
Facility Name
US053
City
Flowood
State/Province
Mississippi
Country
United States
Facility Name
US040
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
US046
City
Houston
State/Province
Texas
Country
United States
Facility Name
US052
City
Houston
State/Province
Texas
Country
United States
Facility Name
US047
City
Milwaukee
State/Province
Wisconsin
Country
United States
Facility Name
BG007
City
Kardjali
Country
Bulgaria
Facility Name
BG002
City
Pazardzhik
Country
Bulgaria
Facility Name
BG003
City
Ruse
Country
Bulgaria
Facility Name
BG001
City
Sofia
Country
Bulgaria
Facility Name
BG004
City
Sofia
Country
Bulgaria
Facility Name
BG005
City
Varna
Country
Bulgaria
Facility Name
BG006
City
Varna
Country
Bulgaria
Facility Name
CA003
City
Burlington
Country
Canada
Facility Name
CA004
City
Edmonton, Alberta
Country
Canada
Facility Name
CA001
City
Kingston
Country
Canada
Facility Name
CA002
City
Montral
Country
Canada
Facility Name
CA005
City
Montreal
Country
Canada
Facility Name
EE002
City
Tallinn
Country
Estonia
Facility Name
EE003
City
Tallinn
Country
Estonia
Facility Name
EE006
City
Tallinn
Country
Estonia
Facility Name
EE001
City
Tartu
Country
Estonia
Facility Name
EE005
City
Tartu
Country
Estonia
Facility Name
EE004
City
Voru
Country
Estonia
Facility Name
FI002
City
Helsinki
Country
Finland
Facility Name
FI003
City
Helsinki
Country
Finland
Facility Name
FI006
City
Helsinki
Country
Finland
Facility Name
FI001
City
Kuopio
Country
Finland
Facility Name
FI007
City
Pori
Country
Finland
Facility Name
FI009
City
Tampere
Country
Finland
Facility Name
DE007
City
Berlin
Country
Germany
Facility Name
DE014
City
Berlin
Country
Germany
Facility Name
DE015
City
Berlin
Country
Germany
Facility Name
DE006
City
Bielefeld
Country
Germany
Facility Name
DE010
City
Bochum
Country
Germany
Facility Name
DE012
City
Gelsenkirchen
Country
Germany
Facility Name
DE009
City
Hannover
Country
Germany
Facility Name
DE022
City
Hattingen
Country
Germany
Facility Name
DE008
City
Heidelberg
Country
Germany
Facility Name
DE017
City
Leipzig
Country
Germany
Facility Name
DE001
City
Nuernberg
Country
Germany
Facility Name
DE004
City
Nuernberg
Country
Germany
Facility Name
DE002
City
Schwerin
Country
Germany
Facility Name
DE016
City
Wiesbaden
Country
Germany
Facility Name
KR001
City
Seoul
Country
Korea, Republic of
Facility Name
KR004
City
Seoul
Country
Korea, Republic of
Facility Name
LV004
City
Daugavpils
Country
Latvia
Facility Name
LV005
City
Jelgava
Country
Latvia
Facility Name
LV002
City
Liepaja
Country
Latvia
Facility Name
LV003
City
Riga
Country
Latvia
Facility Name
LV001
City
Strenci
Country
Latvia
Facility Name
LT006
City
Kaunas Region
Country
Lithuania
Facility Name
LT003
City
Kaunas
Country
Lithuania
Facility Name
LT001
City
Palanga
Country
Lithuania
Facility Name
LT005
City
Silute
Country
Lithuania
Facility Name
LT002
City
Vilnius
Country
Lithuania
Facility Name
LT004
City
Vilnius
Country
Lithuania
Facility Name
MX009
City
Guadalajara
Country
Mexico
Facility Name
MX008
City
Leon
Country
Mexico
Facility Name
MX003
City
Monterrey, Nuevo Len
Country
Mexico
Facility Name
MX002
City
Monterrey
Country
Mexico
Facility Name
PL010
City
Bialystok
Country
Poland
Facility Name
PL016
City
Bialystok
Country
Poland
Facility Name
PL017
City
Bydgoszcz
Country
Poland
Facility Name
PL007
City
Chelmno
Country
Poland
Facility Name
PL002
City
Gdansk
Country
Poland
Facility Name
PL011
City
Gorlice
Country
Poland
Facility Name
PL018
City
Kielce
Country
Poland
Facility Name
PL013
City
Leszno
Country
Poland
Facility Name
PL001
City
Lublin
Country
Poland
Facility Name
PL006
City
Lublin
Country
Poland
Facility Name
PL014
City
Szczecin
Country
Poland
Facility Name
PL012
City
Torun
Country
Poland
Facility Name
PL019
City
Torun
Country
Poland
Facility Name
RO003
City
Bucuresti
Country
Romania
Facility Name
RO006
City
Bucuresti
Country
Romania
Facility Name
RO001
City
Iasi
Country
Romania
Facility Name
RO004
City
Timisoara
Country
Romania
Facility Name
RU002
City
Moscow
Country
Russian Federation
Facility Name
RU004
City
Moscow
Country
Russian Federation
Facility Name
RU003
City
Saint-Petersburg
Country
Russian Federation
Facility Name
RU006
City
Saint-Petersburg
Country
Russian Federation
Facility Name
RU007
City
Saint-Petersburg
Country
Russian Federation
Facility Name
RU010
City
Saint-Petersburg
Country
Russian Federation
Facility Name
RU014
City
Saint-Petersburg
Country
Russian Federation
Facility Name
RU012
City
Saratov
Country
Russian Federation
Facility Name
RU005
City
Stavropol
Country
Russian Federation
Facility Name
SE008
City
Halmstad
Country
Sweden
Facility Name
SE006
City
Malmo
Country
Sweden
Facility Name
SE009
City
Skovde
Country
Sweden
Facility Name
SE001
City
Stockholm
Country
Sweden
Facility Name
UA006
City
Kharkiv
Country
Ukraine
Facility Name
UA007
City
Kherson,Vil. Stepanivka
Country
Ukraine
Facility Name
UA003
City
Kiev
Country
Ukraine
Facility Name
UA014
City
Kiev
Country
Ukraine
Facility Name
UA002
City
Kyiv
Country
Ukraine
Facility Name
UA005
City
Lviv
Country
Ukraine
Facility Name
UA012
City
Ternopil
Country
Ukraine
Facility Name
UA009
City
Vinnytsya
Country
Ukraine
Facility Name
GB003
City
Blackpool
Country
United Kingdom
Facility Name
GB005
City
Bognor Regis
Country
United Kingdom
Facility Name
GB002
City
Bradford
Country
United Kingdom
Facility Name
GB004
City
Cannock
Country
United Kingdom
Facility Name
GB001
City
Leeds
Country
United Kingdom
Facility Name
GB006
City
Winwick
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
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