Schizophrenia
Conditions
Brief summary
This study assess pharmacokinetics and safety of single-administration of Aripiprazole IM Depot formulation at doses of 300 and 400mg in patients with schizophrenia.
Detailed description
In this study, a single-center, single-dose, single-administration trial will be carried out in patients with schizophrenia diagnosed pursuant to The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR), to evaluate pharmacokinetics and safety of single-administration aripiprazole IM Depot (300/400 mg) after its administration in 24 patients with oral tolerance of this drug. In this study, the washout period before administration is designed as a 35-day duration before administration of the investigational drug (aripiprazoleIM Depot), screening period a 4-week duration (28 days) before administration of the investigational drug, observation period after administration a 20-week duration after administration of the investigational drug and hospital stay a minimum 35-day duration after administration of the investigational drug.
Interventions
administration of Aripiprazole IM Depot formulation at doses of 300 and 400mg once in patients with schizophrenia.
Sponsors
Otsuka Beijing Research Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
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. Patients who have other psychiatric disorders than schizophrenia based on diagnostic criteria of DSM-IV-TR; 2. Score of Positive and Negative Syndrome Scale (PANSS): ≥120; 3. Patients with a complication or a history of diabetic mellitus; 4. Subjects who are alcoholemia overdependent of drug, or have drug abuse history; Other protocol-defined inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apparent clearance after extravascular administration | up to 20 weeks | To assess the Apparent clearance after extravascular administration (CL/F) of aripiprazole |
| Maximum Plasma Concentration | up to 20 weeks | To assess the maximum Plasma Concentration (Cmax) of aripiprazole and its main metabolite OPC-14857 |
| Time of Maximum Concentration | up to 20 weeks | To assess the time of Maximum Concentration (tmax) of aripiprazole and its main metabolite OPC-14857 |
| AUC0-∞ | up to 20 weeks | To assess the area under the curve for period of medication, from 0 till infinity (AUC0-∞) of aripiprazole and its main metabolite OPC-14857 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | up to 20 weeks | Adverse events will be examined by frequency, severity, seriousness, discontinuation, and relationship to treatment. |
| Vital Signs | up to 20 weeks | Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for vital signs |
| Laboratory Examination | up to 20 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 20 weeks | To evaluate the change of Positive and Negative Symptoms Scale (PANSS) from baseline. |
Countries
China
Outcome results
None listed