Trial Outcomes & Findings for Evaluation of the Safety of Adjunct Brexpiprazole in Elderly Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Treatment (NCT NCT02400346)
NCT ID: NCT02400346
Last Updated: 2017-08-10
Results Overview
Treatment-emergent adverse event is an adverse event that started or increased in intensity at or after baseline visit
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
132 participants
Primary outcome timeframe
Baseline to 30 weeks
Results posted on
2017-08-10
Participant Flow
Participant milestones
| Measure |
Adjunct Brexpiprazole
All patients continued their current antidepressant treatment and received brexpiprazole open-label in addition.
Adjunct brexpiprazole administration was flexible and included a titration period: Weeks 1-4 titration from 0.5 up to 2 mg once daily, in weekly steps. For the rest of the 26 treatment weeks, maintenance with 1-3 mg once daily.
Tablets for oral use once daily during 26 weeks. Tablet strengths: 0.5 mg, 1 mg, 2 mg and 3 mg.
|
|---|---|
|
Overall Study
STARTED
|
132
|
|
Overall Study
COMPLETED
|
88
|
|
Overall Study
NOT COMPLETED
|
44
|
Reasons for withdrawal
| Measure |
Adjunct Brexpiprazole
All patients continued their current antidepressant treatment and received brexpiprazole open-label in addition.
Adjunct brexpiprazole administration was flexible and included a titration period: Weeks 1-4 titration from 0.5 up to 2 mg once daily, in weekly steps. For the rest of the 26 treatment weeks, maintenance with 1-3 mg once daily.
Tablets for oral use once daily during 26 weeks. Tablet strengths: 0.5 mg, 1 mg, 2 mg and 3 mg.
|
|---|---|
|
Overall Study
Adverse Event
|
24
|
|
Overall Study
Lack of Efficacy
|
9
|
|
Overall Study
Non-compliance with IMP
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Administrative or other reason(s)
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Evaluation of the Safety of Adjunct Brexpiprazole in Elderly Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Treatment
Baseline characteristics by cohort
| Measure |
Adjunct Brexpiprazole
n=132 Participants
All patients continued their current antidepressant treatment and received brexpiprazole open-label in addition.
Adjunct brexpiprazole administration was flexible and included a titration period: Weeks 1-4 titration from 0.5 up to 2 mg once daily, in weekly steps. For the rest of the 26 treatment weeks, maintenance with 1-3 mg once daily.
Tablets for oral use once daily during 26 weeks. Tablet strengths: 0.5 mg, 1 mg, 2 mg and 3 mg.
|
|---|---|
|
Age, Continuous
|
71.4 years
STANDARD_DEVIATION 5.3 • n=85 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=85 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=85 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=85 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=85 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=85 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=85 Participants
|
|
Race (NIH/OMB)
White
|
130 Participants
n=85 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=85 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=85 Participants
|
|
Region of Enrollment
United States
|
52 Participants
n=85 Participants
|
|
Region of Enrollment
Finland
|
27 Participants
n=85 Participants
|
|
Region of Enrollment
Poland
|
17 Participants
n=85 Participants
|
|
Region of Enrollment
Germany
|
15 Participants
n=85 Participants
|
|
Region of Enrollment
Estonia
|
21 Participants
n=85 Participants
|
PRIMARY outcome
Timeframe: Baseline to 30 weeksTreatment-emergent adverse event is an adverse event that started or increased in intensity at or after baseline visit
Outcome measures
| Measure |
Adjunct Brexpiprazole
n=132 Participants
All patients continued their current antidepressant treatment and received brexpiprazole open-label in addition.
Adjunct brexpiprazole administration was flexible and included a titration period: Weeks 1-4 titration from 0.5 up to 2 mg once daily, in weekly steps. For the rest of the 26 treatment weeks, maintenance with 1-3 mg once daily.
Tablets for oral use once daily during 26 weeks. Tablet strengths: 0.5 mg, 1 mg, 2 mg and 3 mg.
|
|---|---|
|
Number of Patients With Treatment-Emergent Adverse Events
|
102 Participants
|
Adverse Events
Brex + ADT
Serious events: 6 serious events
Other events: 79 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Brex + ADT
n=132 participants at risk
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.76%
1/132 • Baseline to end of study (30 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
|
Cardiac disorders
Myocardial rupture
|
0.76%
1/132 • Baseline to end of study (30 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Postoperative wound infection
|
0.76%
1/132 • Baseline to end of study (30 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.76%
1/132 • Baseline to end of study (30 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.76%
1/132 • Baseline to end of study (30 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
|
Injury, poisoning and procedural complications
Fall
|
0.76%
1/132 • Baseline to end of study (30 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Transient ischaemic attack
|
0.76%
1/132 • Baseline to end of study (30 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
|
Psychiatric disorders
Depression
|
0.76%
1/132 • Baseline to end of study (30 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
|
Psychiatric disorders
Major depression
|
0.76%
1/132 • Baseline to end of study (30 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
|
Psychiatric disorders
Panic attack
|
0.76%
1/132 • Baseline to end of study (30 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
|
Vascular disorders
Hypotension
|
0.76%
1/132 • Baseline to end of study (30 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
Other adverse events
| Measure |
Brex + ADT
n=132 participants at risk
|
|---|---|
|
General disorders
Fatigue
|
15.2%
20/132 • Baseline to end of study (30 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
|
Infections and infestations
Nasopharyngitis
|
6.1%
8/132 • Baseline to end of study (30 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
|
Investigations
Weight increased
|
8.3%
11/132 • Baseline to end of study (30 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
|
Metabolism and nutrition disorders
Increased appetite
|
9.8%
13/132 • Baseline to end of study (30 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
7/132 • Baseline to end of study (30 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Akathisia
|
8.3%
11/132 • Baseline to end of study (30 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Dizziness
|
7.6%
10/132 • Baseline to end of study (30 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Headache
|
5.3%
7/132 • Baseline to end of study (30 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
|
Nervous system disorders
Tremor
|
6.8%
9/132 • Baseline to end of study (30 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
|
Psychiatric disorders
Anxiety
|
7.6%
10/132 • Baseline to end of study (30 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
|
Psychiatric disorders
Insomnia
|
6.1%
8/132 • Baseline to end of study (30 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
|
Psychiatric disorders
Restlessness
|
12.9%
17/132 • Baseline to end of study (30 weeks)
Treatment-Emergent Adverse Events are reported in this section
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place