Aripiprazole IM Depot for Chinese Patients With Schizophrenia

Otsuka

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: Aripiprazole IM Depot

Study type: Interventional

Funder types: Industry

Identifiers

NCT03287505

031-403-00050

Details and patient eligibility

About

This study assess pharmacokinetics and safety of single-administration of Aripiprazole IM Depot formulation at doses of 300 and 400mg in patients with schizophrenia.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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 exclusion criteria may apply.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Abilify IM Depot 300mg by once

Experimental group

Description:

300 mg dose group: single-administration of Aripiprazole IM Depot (300 mg) in 12 subjects;

Treatment:

Drug: Aripiprazole IM Depot

Abilify IM Depot 400mg by once

Experimental group

Description:

400 mg dose group: single-administration of Aripiprazole IM Depot (400 mg) in 12 subjects.

Treatment:

Drug: Aripiprazole IM Depot