Trial Outcomes & Findings for Efficacy and Safety of Brexpiprazole as Adjunctive Treatment in Elderly Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment (NCT NCT01837797)
NCT ID: NCT01837797
Last Updated: 2018-10-17
Results Overview
Montgomery and Aasberg Depression Rating Scale (MADRS) total score
TERMINATED
PHASE3
129 participants
From randomisation to end of treatment (week 20)
2018-10-17
Participant Flow
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.
Participant milestones
| Measure |
Period 1 Placebo and ADT
Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)
Placebo: Once daily, tablets, orally
|
Period 2 Placebo and ADT
Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)
Placebo: Once daily, tablets, orally
|
Period 2 Brexpiprazole 1 mg and ADT
Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1 mg once daily, tablets, orally
|
Period 2 Brexpiprazole 3 mg and ADT
Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 3 mg once daily, tablets, orally
|
Period 3 Placebo and ADT
Placebo adjunct to open-label treatment with commercially available antidepressant treatment (ADT)
Placebo: Once daily, tablets, orally
|
|---|---|---|---|---|---|
|
Period 1
STARTED
|
129
|
0
|
0
|
0
|
0
|
|
Period 1
COMPLETED
|
27
|
0
|
0
|
0
|
0
|
|
Period 1
NOT COMPLETED
|
102
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
0
|
6
|
3
|
6
|
0
|
|
Period 2
COMPLETED
|
0
|
1
|
1
|
1
|
0
|
|
Period 2
NOT COMPLETED
|
0
|
5
|
2
|
5
|
0
|
|
Period 3
STARTED
|
0
|
0
|
0
|
0
|
47
|
|
Period 3
COMPLETED
|
0
|
0
|
0
|
0
|
24
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
23
|
Reasons for withdrawal
| Measure |
Period 1 Placebo and ADT
Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)
Placebo: Once daily, tablets, orally
|
Period 2 Placebo and ADT
Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)
Placebo: Once daily, tablets, orally
|
Period 2 Brexpiprazole 1 mg and ADT
Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1 mg once daily, tablets, orally
|
Period 2 Brexpiprazole 3 mg and ADT
Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 3 mg once daily, tablets, orally
|
Period 3 Placebo and ADT
Placebo adjunct to open-label treatment with commercially available antidepressant treatment (ADT)
Placebo: Once daily, tablets, orally
|
|---|---|---|---|---|---|
|
Period 1
Adverse Event
|
9
|
0
|
0
|
0
|
0
|
|
Period 1
Withdrawal by Subject
|
6
|
0
|
0
|
0
|
0
|
|
Period 1
Administrative reasons
|
76
|
0
|
0
|
0
|
0
|
|
Period 1
Withdrawal of consent before treatment
|
1
|
0
|
0
|
0
|
0
|
|
Period 1
Other
|
10
|
0
|
0
|
0
|
0
|
|
Period 2
Administrative or other reasons
|
0
|
5
|
2
|
4
|
0
|
|
Period 2
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
|
Period 3
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
|
Period 3
Administrative reasons
|
0
|
0
|
0
|
0
|
20
|
|
Period 3
Other
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Efficacy and Safety of Brexpiprazole as Adjunctive Treatment in Elderly Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment
Baseline characteristics by cohort
| Measure |
Period 2 Placebo and ADT
n=6 Participants
Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)
Placebo: Once daily, tablets, orally
|
Period 2 Brexpiprazole 1 mg and ADT
n=3 Participants
Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available antidepressant (ADT)
Brexpiprazole: 1 mg once daily, tablets, orally
|
Period 2 Brexpiprazole 3 mg and ADT
n=6 Participants
Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available antidepressant (ADT)
Brexpiprazole: 3 mg once daily, tablets, orally
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From randomisation to end of treatment (week 20)Population: 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
Montgomery and Aasberg Depression Rating Scale (MADRS) total score
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomisation to follow-up (week 24)15 patients were enrolled to Period 2; only 3 patients completed due to study termination
Outcome measures
| Measure |
Period 2 Placebo and ADT
n=6 Participants
Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)
Placebo: Once daily, tablets, orally
|
Period 2 Brexpiprazole 1 mg and ADT
n=3 Participants
Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1 mg once daily, tablets, orally
|
Period 2 Brexpiprazole 3 mg and ADT
n=6 Participants
Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 3 mg once daily, tablets, orally
|
|---|---|---|---|
|
Number of Adverse Events
|
3 Adverse events
|
5 Adverse events
|
2 Adverse events
|
SECONDARY outcome
Timeframe: From randomisation to end of treatment (week 20)Population: 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
Clinical Global Impression - Severity of illness (CGI-S) score
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomisation to end of treatment (week 20)Population: 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
Sheehan Disability Scale (SDS) total score
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomisation to end of treatment (week 20)Population: 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
Social Adaptation Self-evaluation Scale (SASS) total score
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomisation to end of treatment (week 20)Population: 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
Based on a pre-specified decrease in MADRS total score
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomisation to end of treatment (week 20)Population: 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
Based on a pre-specified decrease in MADRS total score
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomisation to end of treatment (week 20)Population: 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
Based on a pre-specified MADRS total score
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomisation to end of treatment (week 20)Population: 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
Based on a pre-specified MADRS total score
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomisation to end of treatment (week 20)Population: 15 patients were enrolled to Period 2, only 3 patients completed due to study termination
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.
Outcome measures
| Measure |
Period 2 Placebo and ADT
n=6 Participants
Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)
Placebo: Once daily, tablets, orally
|
Period 2 Brexpiprazole 1 mg and ADT
n=3 Participants
Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 1 mg once daily, tablets, orally
|
Period 2 Brexpiprazole 3 mg and ADT
n=6 Participants
Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT
Brexpiprazole: 3 mg once daily, tablets, orally
|
|---|---|---|---|
|
Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)
No suicidal ideation or behaviour
|
6 participants
|
3 participants
|
4 participants
|
|
Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)
Any non-suicidal self-injurious behavior
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)
Suicidal Ideation
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)
Preparatory action towards imminent suicidal behav
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)
Not fatal suicide attempt
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)
Completed suicide
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Period 2 Placebo and ADT
Period 2 Brexpiprazole 1 mg and ADT
Period 2 Brexpiprazole 3 mg and ADT
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Period 2 Placebo and ADT
n=6 participants at risk
Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)
Placebo: Once daily, tablets, orally
|
Period 2 Brexpiprazole 1 mg and ADT
n=3 participants at risk
Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available antidepressant (ADT)
Brexpiprazole: 1 mg once daily, tablets, orally
|
Period 2 Brexpiprazole 3 mg and ADT
n=6 participants at risk
Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available antidepressant (ADT)
Brexpiprazole: 3 mg once daily, tablets, orally
|
|---|---|---|---|
|
General disorders
Gait disturbance
|
0.00%
0/6 • From randomization to follow-up
|
33.3%
1/3 • From randomization to follow-up
|
0.00%
0/6 • From randomization to follow-up
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
16.7%
1/6 • From randomization to follow-up
|
0.00%
0/3 • From randomization to follow-up
|
0.00%
0/6 • From randomization to follow-up
|
|
Investigations
Weight increased
|
0.00%
0/6 • From randomization to follow-up
|
33.3%
1/3 • From randomization to follow-up
|
0.00%
0/6 • From randomization to follow-up
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • From randomization to follow-up
|
33.3%
1/3 • From randomization to follow-up
|
0.00%
0/6 • From randomization to follow-up
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/6 • From randomization to follow-up
|
0.00%
0/3 • From randomization to follow-up
|
16.7%
1/6 • From randomization to follow-up
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • From randomization to follow-up
|
33.3%
1/3 • From randomization to follow-up
|
0.00%
0/6 • From randomization to follow-up
|
|
Psychiatric disorders
Bruxism
|
16.7%
1/6 • From randomization to follow-up
|
0.00%
0/3 • From randomization to follow-up
|
0.00%
0/6 • From randomization to follow-up
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • From randomization to follow-up
|
0.00%
0/3 • From randomization to follow-up
|
16.7%
1/6 • From randomization to follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
16.7%
1/6 • From randomization to follow-up
|
0.00%
0/3 • From randomization to follow-up
|
0.00%
0/6 • From randomization to follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • From randomization to follow-up
|
33.3%
1/3 • From randomization to follow-up
|
0.00%
0/6 • From randomization to follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place