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This study assess pharmacokinetics and safety of single-administration of Aripiprazole IM Depot formulation at doses of 300 and 400mg in patients with schizophrenia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abilify IM Depot 300mg by once | Experimental | 300 mg dose group: single-administration of Aripiprazole IM Depot (300 mg) in 12 subjects; |
|
| Abilify IM Depot 400mg by once | Experimental | 400 mg dose group: single-administration of Aripiprazole IM Depot (400 mg) in 12 subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole IM Depot | Drug | administration of Aripiprazole IM Depot formulation at doses of 300 and 400mg once in patients with schizophrenia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration | To assess the maximum Plasma Concentration (Cmax) of aripiprazole and its main metabolite OPC-14857 | up to 20 weeks |
| Time of Maximum Concentration | To assess the time of Maximum Concentration (tmax) of aripiprazole and its main metabolite OPC-14857 | up to 20 weeks |
| AUC0-∞ | To assess the area under the curve for period of medication, from 0 till infinity (AUC0-∞) of aripiprazole and its main metabolite OPC-14857 | up to 20 weeks |
| Apparent clearance after extravascular administration | To assess the Apparent clearance after extravascular administration (CL/F) of aripiprazole | up to 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Adverse events will be examined by frequency, severity, seriousness, discontinuation, and relationship to treatment. | up to 20 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 20 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 20 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 20 weeks |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |