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Efficacy and Safety of Brexpiprazole as Adjunctive Treatment in Elderly Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment

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ClinicalTrials.gov Identifier: NCT01837797
Recruitment Status : Terminated (The study was terminated because of recruitment challenges)
First Posted : April 23, 2013
Results First Posted : March 3, 2016
Last Update Posted : October 17, 2018
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 1 mg
Drug: Brexpiprazole 3 mg
Enrollment 129
Recruitment Details 129 patients were enrolled in the study and 128 patients received open-label treatment with one of six commercially available antidepressant antidepressant treatments (ADT) together with double-blind study treatment. Only 15 patients were randomized to Period 2 before the study was terminated; 47 patients entered Period 3.
Pre-assignment Details  
Arm/Group Title Period 1 Placebo and ADT Period 2 Placebo and ADT Period 2 Brexpiprazole 1 mg and ADT Period 2 Brexpiprazole 3 mg and ADT Period 3 Placebo and ADT
Hide Arm/Group Description

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

Placebo: Once daily, tablets, orally

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

Placebo: Once daily, tablets, orally

Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 1 mg once daily, tablets, orally

Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 3 mg once daily, tablets, orally

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

Placebo: Once daily, tablets, orally

Period Title: Period 1
Started 129 0 0 0 0
Completed 27 0 0 0 0
Not Completed 102 0 0 0 0
Reason Not Completed
Adverse Event             9             0             0             0             0
Withdrawal by Subject             6             0             0             0             0
Administrative reasons             76             0             0             0             0
Withdrawal of consent before treatment             1             0             0             0             0
Other             10             0             0             0             0
Period Title: Period 2
Started 0 6 3 6 0
Completed 0 1 1 1 0
Not Completed 0 5 2 5 0
Reason Not Completed
Administrative or other reasons             0             5             2             4             0
Adverse Event             0             0             0             1             0
Period Title: Period 3
Started 0 0 0 0 47
Completed 0 0 0 0 24
Not Completed 0 0 0 0 23
Reason Not Completed
Adverse Event             0             0             0             0             1
Administrative reasons             0             0             0             0             20
Other             0             0             0             0             2
Arm/Group Title Period 2 Placebo and ADT Period 2 Brexpiprazole 1 mg and ADT Period 2 Brexpiprazole 3 mg and ADT Total
Hide Arm/Group Description

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

Placebo: Once daily, tablets, orally

Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available antidepressant (ADT)

Brexpiprazole: 1 mg once daily, tablets, orally

Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available antidepressant (ADT)

Brexpiprazole: 3 mg once daily, tablets, orally

Total of all reporting groups
Overall Number of Baseline Participants 6 3 6 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 3 participants 6 participants 15 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
6
 100.0%
3
 100.0%
6
 100.0%
15
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 3 participants 6 participants 15 participants
Female
3
  50.0%
2
  66.7%
6
 100.0%
11
  73.3%
Male
3
  50.0%
1
  33.3%
0
   0.0%
4
  26.7%
1.Primary Outcome
Title Change From Randomisation in Depressive Symptoms During the Randomised Treatment
Hide Description Montgomery and Aasberg Depression Rating Scale (MADRS) total score
Time Frame From randomisation to end of treatment (week 20)
Hide Outcome Measure Data
Hide Analysis Population Description
Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients). The limited number of enrolled patients would result in insufficient data for analyses, therefore, no data were collected
Arm/Group Title Period 2 Placebo and ADT Period 2 Brexpiprazole 1 mg and ADT Period 2 Brexpiprazole 3 mg and ADT
Hide Arm/Group Description:

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

Placebo: Once daily, tablets, orally

Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 1 mg once daily, tablets, orally

Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 3 mg once daily, tablets, orally

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Number of Adverse Events
Hide Description 15 patients were enrolled to Period 2; only 3 patients completed due to study termination
Time Frame From randomisation to follow-up (week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Period 2 Placebo and ADT Period 2 Brexpiprazole 1 mg and ADT Period 2 Brexpiprazole 3 mg and ADT
Hide Arm/Group Description:

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

Placebo: Once daily, tablets, orally

Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 1 mg once daily, tablets, orally

Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 3 mg once daily, tablets, orally

Overall Number of Participants Analyzed 6 3 6
Measure Type: Number
Unit of Measure: Adverse events
3 5 2
3.Secondary Outcome
Title Change From Randomisation in Clinical Global Impression During the Randomised Treatment
Hide Description Clinical Global Impression - Severity of illness (CGI-S) score
Time Frame From randomisation to end of treatment (week 20)
Hide Outcome Measure Data
Hide Analysis Population Description
Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients). The limited number of enrolled patients would result in insufficient data for analyses, therefore, no data were collected
Arm/Group Title Period 2 Placebo and ADT Period 2 Brexpiprazole 1 mg and ADT Period 2 Brexpiprazole 3 mg and ADT
Hide Arm/Group Description:

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

Placebo: Once daily, tablets, orally

Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 1 mg once daily, tablets, orally

Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 3 mg once daily, tablets, orally

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change From Randomisation in Functionality Assessed by SDS During the Randomised Treatment
Hide Description Sheehan Disability Scale (SDS) total score
Time Frame From randomisation to end of treatment (week 20)
Hide Outcome Measure Data
Hide Analysis Population Description
Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients). The limited number of enrolled patients would result in insufficient data for analyses, therefore, no data were collected
Arm/Group Title Period 2 Placebo and ADT Period 2 Brexpiprazole 1 mg and ADT Period 2 Brexpiprazole 3 mg and ADT
Hide Arm/Group Description:

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

Placebo: Once daily, tablets, orally

Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 1 mg once daily, tablets, orally

Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 3 mg once daily, tablets, orally

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change From Randomisation in Social Adaptation During the Randomised Treatment
Hide Description Social Adaptation Self-evaluation Scale (SASS) total score
Time Frame From randomisation to end of treatment (week 20)
Hide Outcome Measure Data
Hide Analysis Population Description
Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients). The limited number of enrolled patients would result in insufficient data for analyses, therefore, no data were collected
Arm/Group Title Period 2 Placebo and ADT Period 2 Brexpiprazole 1 mg and ADT Period 2 Brexpiprazole 3 mg and ADT
Hide Arm/Group Description:

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

Placebo: Once daily, tablets, orally

Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 1 mg once daily, tablets, orally

Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 3 mg once daily, tablets, orally

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Response During the Randomised Treatment
Hide Description Based on a pre-specified decrease in MADRS total score
Time Frame From randomisation to end of treatment (week 20)
Hide Outcome Measure Data
Hide Analysis Population Description
Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients). The limited number of enrolled patients would result in insufficient data for analyses, therefore, no data were collected
Arm/Group Title Period 2 Placebo and ADT Period 2 Brexpiprazole 1 mg and ADT Period 2 Brexpiprazole 3 mg and ADT
Hide Arm/Group Description:

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

Placebo: Once daily, tablets, orally

Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 1 mg once daily, tablets, orally

Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 3 mg once daily, tablets, orally

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Sustained Response During the Randomised Treatment
Hide Description Based on a pre-specified decrease in MADRS total score
Time Frame From randomisation to end of treatment (week 20)
Hide Outcome Measure Data
Hide Analysis Population Description
Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients). The limited number of enrolled patients would result in insufficient data for analyses, therefore, no data were collected
Arm/Group Title Period 2 Placebo and ADT Period 2 Brexpiprazole 1 mg and ADT Period 2 Brexpiprazole 3 mg and ADT
Hide Arm/Group Description:

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

Placebo: Once daily, tablets, orally

Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 1 mg once daily, tablets, orally

Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 3 mg once daily, tablets, orally

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Remission During the Randomised Treatment
Hide Description Based on a pre-specified MADRS total score
Time Frame From randomisation to end of treatment (week 20)
Hide Outcome Measure Data
Hide Analysis Population Description
Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients). The limited number of enrolled patients would result in insufficient data for analyses, therefore, no data were collected
Arm/Group Title Period 2 Placebo and ADT Period 2 Brexpiprazole 1 mg and ADT Period 2 Brexpiprazole 3 mg and ADT
Hide Arm/Group Description:

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

Placebo: Once daily, tablets, orally

Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 1 mg once daily, tablets, orally

Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 3 mg once daily, tablets, orally

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Sustained Remission During the Randomised Treatment
Hide Description Based on a pre-specified MADRS total score
Time Frame From randomisation to end of treatment (week 20)
Hide Outcome Measure Data
Hide Analysis Population Description
Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients). The limited number of enrolled patients would result in insufficient data for analyses, therefore, no data were collected
Arm/Group Title Period 2 Placebo and ADT Period 2 Brexpiprazole 1 mg and ADT Period 2 Brexpiprazole 3 mg and ADT
Hide Arm/Group Description:

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

Placebo: Once daily, tablets, orally

Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 1 mg once daily, tablets, orally

Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 3 mg once daily, tablets, orally

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)
Hide Description The Columbia Suicide Severity Rating Scale (eC-SSRS) is a semi-structured interview developed to systematically assess suicidal ideation and behaviour of patients participating in a clinical study. The C-SSRS has 5 questions addressing suicidal ideation, 5 sub-questions assessing the intensity of ideation, and 4 questions addressing suicidal behaviour.
Time Frame From randomisation to end of treatment (week 20)
Hide Outcome Measure Data
Hide Analysis Population Description
15 patients were enrolled to Period 2, only 3 patients completed due to study termination
Arm/Group Title Period 2 Placebo and ADT Period 2 Brexpiprazole 1 mg and ADT Period 2 Brexpiprazole 3 mg and ADT
Hide Arm/Group Description:

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

Placebo: Once daily, tablets, orally

Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 1 mg once daily, tablets, orally

Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT

Brexpiprazole: 3 mg once daily, tablets, orally

Overall Number of Participants Analyzed 6 3 6
Measure Type: Number
Unit of Measure: participants
No suicidal ideation or behaviour 6 3 4
Any non-suicidal self-injurious behavior 0 0 0
Suicidal Ideation 0 0 2
Preparatory action towards imminent suicidal behav 0 0 0
Not fatal suicide attempt 0 0 0
Completed suicide 0 0 0
Time Frame From randomization to follow-up
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Period 2 Placebo and ADT Period 2 Brexpiprazole 1 mg and ADT Period 2 Brexpiprazole 3 mg and ADT
Hide Arm/Group Description

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

Placebo: Once daily, tablets, orally

Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available antidepressant (ADT)

Brexpiprazole: 1 mg once daily, tablets, orally

Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available antidepressant (ADT)

Brexpiprazole: 3 mg once daily, tablets, orally

All-Cause Mortality
Period 2 Placebo and ADT Period 2 Brexpiprazole 1 mg and ADT Period 2 Brexpiprazole 3 mg and ADT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Period 2 Placebo and ADT Period 2 Brexpiprazole 1 mg and ADT Period 2 Brexpiprazole 3 mg and ADT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/3 (0.00%)   0/6 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Period 2 Placebo and ADT Period 2 Brexpiprazole 1 mg and ADT Period 2 Brexpiprazole 3 mg and ADT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/6 (33.33%)   2/3 (66.67%)   2/6 (33.33%) 
General disorders       
Gait disturbance  1  0/6 (0.00%)  1/3 (33.33%)  0/6 (0.00%) 
Injury, poisoning and procedural complications       
Accidental overdose  1  1/6 (16.67%)  0/3 (0.00%)  0/6 (0.00%) 
Investigations       
Weight increased  1  0/6 (0.00%)  1/3 (33.33%)  0/6 (0.00%) 
Nervous system disorders       
Dizziness  1  0/6 (0.00%)  1/3 (33.33%)  0/6 (0.00%) 
Parkinson's disease  1  0/6 (0.00%)  0/3 (0.00%)  1/6 (16.67%) 
Tremor  1  0/6 (0.00%)  1/3 (33.33%)  0/6 (0.00%) 
Psychiatric disorders       
Bruxism  1  1/6 (16.67%)  0/3 (0.00%)  0/6 (0.00%) 
Insomnia  1  0/6 (0.00%)  0/3 (0.00%)  1/6 (16.67%) 
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  1/6 (16.67%)  0/3 (0.00%)  0/6 (0.00%) 
Dyspnoea  1  0/6 (0.00%)  1/3 (33.33%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Because the study was terminated, few efficacy data were collected. These data have not been reported in accordance with the ICH E3 regarding abbreviated clinical study reports. Furthermore, no firm conclusions can be drawn regarding safety.
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 H. Lundbeck A/S
Organization: Study Director
EMail: LundbeckClinicalTrials@lundbeck.com
Layout table for additonal information
Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01837797    
Other Study ID Numbers: 14571A
2012-001361-32 ( EudraCT Number )
First Submitted: April 4, 2013
First Posted: April 23, 2013
Results First Submitted: August 17, 2015
Results First Posted: March 3, 2016
Last Update Posted: October 17, 2018