Schizophrenia
Conditions
Brief summary
To determine the safety and efficacy of brexpiprazole during long-term treatment.
Interventions
DRUGBrexpiprazole
1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration).
Sponsors
Otsuka Pharmaceutical Co., Ltd.
H. Lundbeck A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* The patient has completed the lead-in study 14644A. * The patient is judged to potentially benefit from 52-week treatment with brexpiprazole according to the clinical opinion of the investigator. * The patient agrees to protocol-defined use of effective contraception.
Exclusion criteria
* The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 14644A. * The patient has a clinically significant unstable illness diagnosed during Study 14644A. * The patient, in the opinion of the investigator or according to Columbia-Suicide Severity Rating Scale (C-SSRS), is at significant risk of suicide. * The patient has an abnormal ECG or other abnormal ECG tests that are, in the investigator's opinion, clinically significant. * The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason. Other inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | Up to 52 weeks and a safety follow-up by telephone contact or clinic visit after 30 days after the last dose of investigational medicinal product (IMP) | Number of treatment-emergent adverse events (TEAEs) |
Countries
Estonia, Poland, Romania, Russia, Serbia, Slovakia, Ukraine, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Brexpiprazole Brexpiprazole: 1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration). | 210 |
| Total | 210 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adminstrative or other reason(s) | 23 |
| Overall Study | Adverse Event | 32 |
| Overall Study | Enrolled, not treated | 1 |
| Overall Study | Lack of Efficacy | 12 |
| Overall Study | Lost to Follow-up | 10 |
| Overall Study | Non-compliance with IMP | 4 |
| Overall Study | Protocol Violation | 5 |
| Overall Study | Withdrawal by Subject | 22 |
Baseline characteristics
| Characteristic | Brexpiprazole |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 208 Participants |
| Age, Continuous | 40.89 years STANDARD_DEVIATION 11.35 |
| Region of Enrollment Estonia | 6 participants |
| Region of Enrollment Poland | 9 participants |
| Region of Enrollment Romania | 9 participants |
| Region of Enrollment Russian Federation | 52 participants |
| Region of Enrollment Serbia | 19 participants |
| Region of Enrollment Slovakia | 1 participants |
| Region of Enrollment Ukraine | 64 participants |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 113 Participants |
| Sex: Female, Male Male | 97 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 47 / 209 |
| serious Total, serious adverse events | 31 / 209 |
Outcome results
Primary
Safety and Tolerability
Number of treatment-emergent adverse events (TEAEs)
Time frame: Up to 52 weeks and a safety follow-up by telephone contact or clinic visit after 30 days after the last dose of investigational medicinal product (IMP)
Population: 210 patients were enrolled, only 209 patients were treated with brexpiprazole.TAES is based on these 209 patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brexpiprazole | Safety and Tolerability | 337 TEAEs |