Trial Outcomes & Findings for Long-term Safety and Tolerability Study of Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder (NCT NCT01944969)
NCT ID: NCT01944969
Last Updated: 2018-10-17
Results Overview
Number of participants with Treatment-Emergent Adverse Events
TERMINATED
PHASE3
26 participants
From baseline to Week 52
2018-10-17
Participant Flow
Participant milestones
| Measure |
Brexpiprazole and ADT
Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
26
|
Reasons for withdrawal
| Measure |
Brexpiprazole and ADT
Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Non-compliance with IMP
|
1
|
|
Overall Study
Administrative or other reasons
|
23
|
Baseline Characteristics
Long-term Safety and Tolerability Study of Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Brexpiprazole and ADT
n=26 Participants
Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
|
Age, Continuous
|
66.12 years
STANDARD_DEVIATION 10.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Estonia
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to Week 52Number of participants with Treatment-Emergent Adverse Events
Outcome measures
| Measure |
Brexpiprazole and ADT
n=26 Participants
Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally
|
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events
|
28 participants
|
PRIMARY outcome
Timeframe: From baseline to Week 52Population: 26 patients were withdrawn; the reason for withdrawal was not poor tolerability, but mainly (23 patients) because the study was terminated. Please see withdrawn reasons in the participant flow section for the other reasons.
Number of withdrawals
Outcome measures
| Measure |
Brexpiprazole and ADT
n=26 Participants
Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally
|
|---|---|
|
Number of Withdrawals
|
26 participants
|
SECONDARY outcome
Timeframe: From baseline to Week 52Population: all-patients treated set (APTS)
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. The electronic C-SSRS (eC-SSRS) is a patient-rated electronic version using interactive voice response technology. A structured CSSRS script of standardised questions, follow-up prompts, error-handling and scoring conventions is used for administration.
Outcome measures
| Measure |
Brexpiprazole and ADT
n=26 Participants
Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally
|
|---|---|
|
Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)
Suicidal Ideation
|
1 participants
|
|
Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)
Preparatory action towards imminent suicidal
|
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
|
|
Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)
No suicidal ideation or behaviour
|
25 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
|
|
Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)
Completed suicide
|
0 participants
|
SECONDARY outcome
Timeframe: From baseline to Week 52Population: None of the patients completed the study. A total of 26 patients were enrolled when the study was prematurely terminated(Planned: 1184 patients). No data were collected because none of the 26 patients that were enrolled completed the study because of early termination.
The Montgomery and Aasberg Depression Rating Scale (MADRS) total score
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline to Week 52Population: No patients completed the study. Only 26 patients were enrolled at prematurely study termination (Planned: 1184 patients). No data were collected because none of the 26 patients that were enrolled completed the study because of early termination.
Based on a pre-specified MADRS total score
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline to Week 52Population: No patients completed the study. Only 26 patients were enrolled at prematurely study termination (Planned: 1184 patients). No data were collected because none of the 26 patients that were enrolled completed the study because of early termination.
Clinical Global Impression - Severity of illness (CGI-S) score
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From baseline to Week 52Population: No patients completed the study. Only 26 patients were enrolled at prematurely study termination (Planned: 1184 patients). No data were collected because none of the 26 patients that were enrolled completed the study because of early termination.
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-(SF)) total score
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 52Population: No patients completed the study. Only 26 patients were enrolled at prematurely study termination (Planned: 1184 patients). No data were collected because none of the 26 patients that were enrolled completed the study because of early termination.
The EuroQoL 5 Dimensions 5L version (EQ-5D-5L) Visual Analogue Scale (VAS) is a patient-reported assessment designed to measure the patient's wellbeing. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a visual analogue scale (VAS) of the overall health state. Each descriptive item is rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems) and a single summary index (from 0 to 1) can be calculated. The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
Outcome measures
Outcome data not reported
Adverse Events
Brexpiprazole and ADT
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Brexpiprazole and ADT
n=26 participants at risk
Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)
Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally
|
|---|---|
|
Injury, poisoning and procedural complications
Accidental overdose
|
11.5%
3/26 • From baseline to Week 52
|
|
Nervous system disorders
Lethargy
|
7.7%
2/26 • From baseline to Week 52
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place