Trial Outcomes & Findings for Study of Safety & Tolerability of OPC-34712 as Adjunctive Therapy in Treatment of Adult Patients With Major Depressive Disorder (NCT NCT01447576)
NCT ID: NCT01447576
Last Updated: 2015-11-06
Results Overview
An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug-related by the physician. The severity was assessed as mild, moderate, or severe. A treament-emergent AE (TEAE) was defined as any AE that started after start of open-label brexpiprazole; or if the event was continuous from baseline and was worsening, serious, study drug-related, or resulted in death, discontinuation, interruption, or reduction of study drug.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1036 participants
Primary outcome timeframe
After the Informed Consent Form (ICF) was signed, through Follow up 30 (+2) days after last visit
Results posted on
2015-11-06
Participant Flow
1036 participants entered trial, including 792 who had rolled over from previous studies and 244 de novo participants. Of the 792 rollovers, 337 were 6-week enrollers and the 52-week enrollers consisted of 699 enrolled participants (455 rollover and 244 de novo). This was a single arm study and all participants received the same treatment.
Eligible participants received daily treatment with open-label brexpiprazole (0.25 up to 3.0 milligrams (mg)/day) and commercially marketed ADT.
Participant milestones
| Measure |
Brexpiprazole +ADT
All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
|
|---|---|
|
Overall Study
STARTED
|
1036
|
|
Overall Study
COMPLETED
|
560
|
|
Overall Study
NOT COMPLETED
|
476
|
Reasons for withdrawal
| Measure |
Brexpiprazole +ADT
All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
52
|
|
Overall Study
Adverse Event
|
127
|
|
Overall Study
Participant met withdrawal criteria
|
40
|
|
Overall Study
Withdrawal by Subject
|
100
|
|
Overall Study
Protocol deviation
|
83
|
|
Overall Study
Lack of Efficacy
|
68
|
|
Overall Study
Physician Decision
|
6
|
Baseline Characteristics
Study of Safety & Tolerability of OPC-34712 as Adjunctive Therapy in Treatment of Adult Patients With Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Brexpiprazole+ADT
n=1036 Participants
All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
|
|---|---|
|
Age, Continuous
|
44.0 Years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
702 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
334 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After the Informed Consent Form (ICF) was signed, through Follow up 30 (+2) days after last visitPopulation: The primary safety dataset included all participants exposed to at least 1 dose of brexpiprazole.
An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug-related by the physician. The severity was assessed as mild, moderate, or severe. A treament-emergent AE (TEAE) was defined as any AE that started after start of open-label brexpiprazole; or if the event was continuous from baseline and was worsening, serious, study drug-related, or resulted in death, discontinuation, interruption, or reduction of study drug.
Outcome measures
| Measure |
Brexpiprazole+ADT
n=1034 Participants
All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
|
|---|---|
|
Participants With Adverse Events (AEs).
Participants with TEAEs
|
851 Participants
|
|
Participants With Adverse Events (AEs).
Participants with serious TEAEs
|
30 Participants
|
SECONDARY outcome
Timeframe: Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and 52 (last-observation-carried-forward [LOCF])Population: Efficacy dataset had participants who received at least 1 dose of brexpiprazole and had a baseline and at least 1 postbaseline efficacy evaluation for CGI-S. LOCF dataset included data recorded at a given visit in treatment phase or, if no observation was recorded at that visit, data carried forward from the previous visit in the Treatment Phase.
The CGI-S is a 7-point scale from 1 through 7. The items on CGI-S scale are: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill participants. The score 0 (= not assessed) was set to missing.
Outcome measures
| Measure |
Brexpiprazole+ADT
n=1032 Participants
All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
|
|---|---|
|
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score.
Week 1
|
-0.09 Units on a scale
Standard Deviation 0.60
|
|
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score.
Week 2
|
-0.35 Units on a scale
Standard Deviation 0.82
|
|
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score.
Week 4
|
-0.63 Units on a scale
Standard Deviation 0.96
|
|
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score.
Week 6
|
-0.79 Units on a scale
Standard Deviation 1.03
|
|
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score.
Week 8
|
-0.92 Units on a scale
Standard Deviation 1.12
|
|
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score.
Week 14
|
-0.93 Units on a scale
Standard Deviation 1.14
|
|
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score.
Week 20
|
-1.08 Units on a scale
Standard Deviation 1.17
|
|
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score.
Week 26
|
-1.13 Units on a scale
Standard Deviation 1.24
|
|
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score.
Week 32
|
-1.24 Units on a scale
Standard Deviation 1.24
|
|
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score.
Week 38
|
-1.37 Units on a scale
Standard Deviation 1.28
|
|
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score.
Week 44
|
-1.46 Units on a scale
Standard Deviation 1.27
|
|
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score.
Week 52
|
-1.52 Units on a scale
Standard Deviation 1.34
|
|
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score.
Week 52-LOCF
|
-0.81 Units on a scale
Standard Deviation 1.24
|
SECONDARY outcome
Timeframe: Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and 52 (LOCF)Population: Efficacy dataset had participants who received at least 1 dose of brexpiprazole and had a baseline and atleast 1 postbaseline efficacy evaluation for CGI-S. LOCF dataset included data recorded at a given visit in treatment phase or, if no observation was recorded at that visit, data carried forward from the previous visit in the Treatment Phase.
The items on CGI-I scale are 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. The score of 0 (= not assessed) was set to missing. The CGI-I is therefore a 7-point scale from 1 through 7. CGI improvement was compared to the participants condition at Baseline.
Outcome measures
| Measure |
Brexpiprazole+ADT
n=1023 Participants
All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
|
|---|---|
|
Mean Clinical Global Impression - Improvement (CGI-I) Scale Score.
Week 4
|
2.67 Units on a scale
Standard Deviation 1.09
|
|
Mean Clinical Global Impression - Improvement (CGI-I) Scale Score.
Week 6
|
2.46 Units on a scale
Standard Deviation 1.10
|
|
Mean Clinical Global Impression - Improvement (CGI-I) Scale Score.
Week 8
|
2.36 Units on a scale
Standard Deviation 1.10
|
|
Mean Clinical Global Impression - Improvement (CGI-I) Scale Score.
Week 14
|
2.36 Units on a scale
Standard Deviation 1.23
|
|
Mean Clinical Global Impression - Improvement (CGI-I) Scale Score.
Week 20
|
2.22 Units on a scale
Standard Deviation 1.17
|
|
Mean Clinical Global Impression - Improvement (CGI-I) Scale Score.
Week 26
|
2.16 Units on a scale
Standard Deviation 1.12
|
|
Mean Clinical Global Impression - Improvement (CGI-I) Scale Score.
Week 32
|
2.08 Units on a scale
Standard Deviation 1.13
|
|
Mean Clinical Global Impression - Improvement (CGI-I) Scale Score.
Week 38
|
1.97 Units on a scale
Standard Deviation 1.11
|
|
Mean Clinical Global Impression - Improvement (CGI-I) Scale Score.
Week 44
|
1.91 Units on a scale
Standard Deviation 1.14
|
|
Mean Clinical Global Impression - Improvement (CGI-I) Scale Score.
Week 52
|
1.92 Units on a scale
Standard Deviation 1.15
|
|
Mean Clinical Global Impression - Improvement (CGI-I) Scale Score.
Week 52-LOCF
|
2.57 Units on a scale
Standard Deviation 1.31
|
|
Mean Clinical Global Impression - Improvement (CGI-I) Scale Score.
Week 1
|
3.38 Units on a scale
Standard Deviation 0.94
|
|
Mean Clinical Global Impression - Improvement (CGI-I) Scale Score.
Week 2
|
3.04 Units on a scale
Standard Deviation 1.06
|
Adverse Events
Brexpiprazole+ADT
Serious events: 29 serious events
Other events: 684 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Brexpiprazole+ADT
n=1034 participants at risk；n=697 participants at risk
Participants received brexpiprazole 0.25 to 3.0mg/day plus ADT.
|
|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
0.14%
1/697 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
General disorders
Non-cardiac chest pain
|
0.14%
1/697 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.14%
1/697 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.14%
1/697 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Infections and infestations
Pneumonia
|
0.14%
1/697 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Infections and infestations
Pyelonephritis
|
0.14%
1/697 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.29%
2/697 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.14%
1/697 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of the cervix
|
0.14%
1/697 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.14%
1/697 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Nervous system disorders
Convulsion
|
0.14%
1/697 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Nervous system disorders
Cranial nerve paralysis
|
0.14%
1/697 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Nervous system disorders
Dizziness
|
0.14%
1/697 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Nervous system disorders
Sciatica
|
0.14%
1/697 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.14%
1/697 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Psychiatric disorders
Anxiety
|
0.29%
2/697 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Psychiatric disorders
Depression
|
0.43%
3/697 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Psychiatric disorders
Depression suicidal
|
0.14%
1/697 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Psychiatric disorders
Depressive symptom
|
0.14%
1/697 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Psychiatric disorders
Suicidal ideation
|
0.43%
3/697 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Psychiatric disorders
Suicide attempt
|
0.43%
3/697 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.14%
1/697 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.14%
1/697 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.14%
1/697 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
Other adverse events
| Measure |
Brexpiprazole+ADT
n=1034 participants at risk；n=697 participants at risk
Participants received brexpiprazole 0.25 to 3.0mg/day plus ADT.
|
|---|---|
|
General disorders
Fatigue
|
9.2%
95/1034 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.5%
67/1034 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Investigations
Weight increased
|
21.0%
217/1034 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Metabolism and nutrition disorders
Increased appetite
|
8.4%
87/1034 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Nervous system disorders
Akathisia
|
9.9%
102/1034 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Nervous system disorders
Dizziness
|
5.8%
60/1034 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Nervous system disorders
Headache
|
8.4%
87/1034 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Nervous system disorders
Sedation
|
5.2%
54/1034 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Nervous system disorders
Somnolence
|
9.1%
94/1034 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Nervous system disorders
Tremor
|
4.1%
42/1034 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Psychiatric disorders
Anxiety
|
6.5%
67/1034 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Psychiatric disorders
Insomnia
|
8.8%
91/1034 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Psychiatric disorders
Restlessness
|
5.7%
59/1034 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Gastrointestinal disorders
Constipation
|
4.0%
41/1034 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.1%
42/1034 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Gastrointestinal disorders
Dry mouth
|
3.9%
40/1034 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Gastrointestinal disorders
Nausea
|
4.8%
50/1034 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Infections and infestations
Nasopharyngitis
|
4.5%
47/1034 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
33/1034 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Psychiatric disorders
Abnormal dreams
|
4.0%
41/1034 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
|
Psychiatric disorders
Middle insomnia
|
2.3%
24/1034 • After the ICF was signed, through the treatment period and through Follow-up (telephone contact or in-clinic visit) 30 (+ 2) days after the last visit.
The safety sample consisted of participants who received at least 1 dose of brexpiprazole. Serious adverse event data were available for 697 participants (52 Week enrollers). Non-serious AE data were available for 1034 participants.
|
Additional Information
Global Medical Affairs
Otsuka Pharmaceutical Development & Commercialization, Inc
Phone: 800 562-3974
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place