Schizophrenia
Conditions
Brief summary
This study assess pharmacokinetics and safety of multi-administration of Aripiprazole IM Depot formulation at doses of 400mg in patients with schizophrenia.
Detailed description
To evaluate the pharmacokinetics and safety of aripiprazole prolonged IM depot 400mg administered to Chinese adult subjects with schizophrenia every four weeks for 20 consecutive weeks
Interventions
administration of Aripiprazole IM Depot formulation at doses of 400 mg for 5 times in patients with schizophrenia.
Sponsors
Otsuka Beijing Research Institute
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
1. Subjects, and their legal representatives(or their guardian ), who have signed the informed consent form(ICF); 2. Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR (295.30, 295.10, 295.20,295.90 , 295.60); 3. subjects, both male and female, who are at age between 18 and 64 (also including 18 and 64 years of age) at time of informed consent.
Exclusion criteria
1. Presence of other mental disorders than schizophrenia confirmed through diagnostic criteria of DSM-IV-TR; 2. Subjects who are alcoholomania or independent of drug, or have drug abuse history; 3. Positive for any of HIV antibody, HBsAg, HCV antibody and syphilis serology testing; Other protocol-defined inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apparent clearance after extravascular administration | up to 24 weeks | To assess the apparent clearance after extravascular administration (CL/F) of aripiprazole after administration of the fifth IMD dose. |
| Maximum Plasma Concentration (Cmax) | up to 24 weeks | To assess the Maximum Plasma Concentration (Cmax) of aripiprazole and its primary metabolite OPC-14857 after administration of the fifth IMD dose. |
| time of maximum observed plasma concentration (tmax) | up to 24 week | To assess the time of maximum observed plasma concentration (tmax) of aripiprazole and its primary metabolite OPC-14857 after administration of the fifth IMD dose. |
| AUC672h | up to 24 weeks | To assess the time of maximum observed plasma concentration (tmax) of aripiprazole and its primary metabolite OPC-14857 after administration of the fifth IMD dose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | up to 24 weeks | Adverse events will be examined by frequency, severity, seriousness, discontinuation, and relationship to treatment |
| Vital Signs | up to 24 weeks | Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for vital signs |
| Laboratory Examination | up to 24 weeks | Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for routine laboratory tests (including prolactin) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Symptoms Scale (PANSS) | up to 24 weeks | To evaluate the change of Positive and Negative Symptoms Scale (PANSS) from baseline. |
Countries
China
Outcome results
None listed