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This study assess pharmacokinetics and safety of multi-administration of Aripiprazole IM Depot formulation at doses of 400mg in patients with schizophrenia.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 400 mg group | Experimental | Aripiprazole IM depot 400mg will be administered every four weeks for 20 weeks after drug switch / steady dose of oral aripiprazole tablets (each subject will receive 5 intramuscular injections totally). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole IM Depot | Drug | administration of Aripiprazole IM Depot formulation at doses of 400 mg for 5 times in patients with schizophrenia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Adverse events will be examined by frequency, severity, seriousness, discontinuation, and relationship to treatment | up to 24 weeks |
| Vital Signs | Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for vital signs |
| Measure | Description | Time Frame |
|---|---|---|
| Positive and Negative Symptoms Scale (PANSS) | To evaluate the change of Positive and Negative Symptoms Scale (PANSS) from baseline. | up to 24 weeks |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Tao Jiang, Master | Beijing Anding Hospital of Capital Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anding Hospital of Capital Medical University | Beijing | Beijing Municipality | 100088 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41034820 | Derived | Dong F, Wang F, Yuan X, Zhai Y, Uki M, Jiang T, Li A. Single- and multiple-dose pharmacokinetics, safety, and tolerability of Aripiprazole once-monthly, long-acting intramuscular injection for Chinese adults with schizophrenia. BMC Psychiatry. 2025 Oct 1;25(1):912. doi: 10.1186/s12888-025-07407-w. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
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| up to 24 weeks |
| 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 |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |