Schizophrenia
Conditions
Keywords
Aripiprazole, Deltoid
Brief summary
To assess the pharmacokinetics and safety of aripiprazole intra-muscular (IM) depot formulation in patients with schizophrenia after repeated administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals
Interventions
DRUGOPC-14597 IMD
Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Patients with a diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual (DSM)-IV-Text Revision (TR) (295.30, 295.10, 295.20, 295.90, 295.60) * Patients who have provided written informed consent by themselves (If the patient is a minor, written consent from a legal representative must be obtained in addition to the patient's own written informed consent.) * Patients, both male and female, aged 18 years or older, but younger than 65 years, at the time of obtaining informed consent * Patients with a body mass index of 18.5 or higher and lower than 35.0 * Patients whose mental condition is stable or well maintained for 2 weeks or more without any change to dosage regimen for their non-aripiprazole oral atypical antipsychotic monotherapy prior to obtaining informed consent * Patients who have received aripiprazole in the past
Exclusion criteria
* Patients diagnosed as having a mental disorder other than schizophrenia, as defined by DSM-IV-TR criteria. * Patients with a history or complication of diabetes. * Patients with hepatic, renal, cardiac, or hematopoietic disorders. * Female patients who are pregnant or lactating, who may possibly be pregnant, who wish to become pregnant, or male patients whose partner wishes to become pregnant. * Patients who have a drug allergy or drug hypersensitivity * Patients for whom clozapine has been ineffective, patients who have responded only to clozapine, or patients who are currently being treated with clozapine. * Patients with a complication of Parkinson's Disease (excluding drug-induced Parkinsonism). * Patients with a history or a complication of neuroleptic malignant syndrome, rhabdomyolysis, tardive dyskinesia, paralytic ileus or water intoxication. * Patients with a history or a complication of psychological or behavioral abnormalities associated with use of psychoactive substances (abuse of alcohol, narcotics, or organic solvent, etc). * Patients with a history or a complication of suicide attempt or self-injury within 52 weeks prior to obtaining informed consent. * Patients with a history of or a complication of convulsive disorder such as epilepsy. * Patients with a history of or a complication of organic brain disorder including cerebrovascular disease. * Patients with a history or a complication of granulocytopenia or agranulocytosis. * Patients who have received electro-convulsive therapy (ECT) within 12 weeks prior to obtaining informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OPC-14597 Plasma Concentration 672 Hours Postdose Following Multiple Administration of OPC-14597 IMD Injections | 672 hours postdose of the first, second, third, fourth, and fifth IMD injections |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OPC-14597 IMD Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Exacerbation of symptoms of an underlying disease | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | OPC-14597 IMD |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Age, Continuous | 39.2 years STANDARD_DEVIATION 11.4 |
| Race/Ethnicity, Customized Japanese | 17 Participants |
| Region of Enrollment Japan | 17 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 15 / 17 |
| serious Total, serious adverse events | 2 / 17 |
Outcome results
Primary
OPC-14597 Plasma Concentration 672 Hours Postdose Following Multiple Administration of OPC-14597 IMD Injections
Time frame: 672 hours postdose of the first, second, third, fourth, and fifth IMD injections
Population: Pharmacokinetic analysis set included subjects whose plasma concentrations were measured without deviation at all blood sampling timepoints during the OPC-14597 IMD treatment period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OPC-14597 IMD (First Dose) | OPC-14597 Plasma Concentration 672 Hours Postdose Following Multiple Administration of OPC-14597 IMD Injections | 91.9 ng/mL | Standard Deviation 29.4 |
| OPC-14597 IMD (Second Dose) | OPC-14597 Plasma Concentration 672 Hours Postdose Following Multiple Administration of OPC-14597 IMD Injections | 141 ng/mL | Standard Deviation 54 |
| OPC-14597 IMD (Third Dose) | OPC-14597 Plasma Concentration 672 Hours Postdose Following Multiple Administration of OPC-14597 IMD Injections | 171 ng/mL | Standard Deviation 76.1 |
| OPC-14597 IMD (Fourth Dose) | OPC-14597 Plasma Concentration 672 Hours Postdose Following Multiple Administration of OPC-14597 IMD Injections | 198 ng/mL | Standard Deviation 102 |
| OPC-14597 IMD (Fifth | OPC-14597 Plasma Concentration 672 Hours Postdose Following Multiple Administration of OPC-14597 IMD Injections | 201 ng/mL | Standard Deviation 88.9 |