Schizophrenia Clinical Trial
Official title:
A Single-center, Uncontrolled, Open-label Clinical Trial Evaluating the Pharmacokinetic Characteristics and Safety of Aripiprazole IM Depot in Chinese Patients With Schizophrenia After Multi-dose Administration
Verified date | January 2020 |
Source | Otsuka Beijing Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study assess pharmacokinetics and safety of multi-administration of Aripiprazole IM Depot formulation at doses of 400mg in patients with schizophrenia.
Status | Completed |
Enrollment | 12 |
Est. completion date | October 14, 2019 |
Est. primary completion date | October 14, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility |
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 exclusion criteria may apply. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Anding Hospital of Capital Medical University | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Otsuka Beijing Research Institute |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Positive and Negative Symptoms Scale (PANSS) | To evaluate the change of Positive and Negative Symptoms Scale (PANSS) from baseline. | up to 24 weeks | |
Primary | Maximum Plasma Concentration (Cmax) | To assess the Maximum Plasma Concentration (Cmax) of aripiprazole and its primary metabolite OPC-14857 after administration of the fifth IMD dose. | up to 24 weeks | |
Primary | time of maximum observed plasma concentration (tmax) | 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. | up to 24 week | |
Primary | AUC672h | 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. | up to 24 weeks | |
Primary | Apparent clearance after extravascular administration | To assess the apparent clearance after extravascular administration (CL/F) of aripiprazole after administration of the fifth IMD dose. | up to 24 weeks | |
Secondary | Adverse Events | Adverse events will be examined by frequency, severity, seriousness, discontinuation, and relationship to treatment | up to 24 weeks | |
Secondary | Vital Signs | Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for vital signs | up to 24 weeks | |
Secondary | Laboratory Examination | Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for routine laboratory tests (including prolactin) | up to 24 weeks |
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