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Aripiprazole IM Depot for Chinese Patients With Schizophrenia

NCT ID: NCT03287505

Last Updated: 2020-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-23

Study Completion Date

2019-11-08

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Abilify IM Depot 300mg by once

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

Group Type EXPERIMENTAL

Aripiprazole IM Depot

Intervention Type DRUG

administration of Aripiprazole IM Depot formulation at doses of 300 and 400mg once in patients with schizophrenia.

Abilify IM Depot 400mg by once

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

Group Type EXPERIMENTAL

Aripiprazole IM Depot

Intervention Type DRUG

administration of Aripiprazole IM Depot formulation at doses of 300 and 400mg once in patients with schizophrenia.

Interventions

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Aripiprazole IM Depot

administration of Aripiprazole IM Depot formulation at doses of 300 and 400mg once in patients with schizophrenia.

Intervention Type DRUG

Other Intervention Names

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ABILIFY MAINTENA

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka Beijing Research Institute

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tao Jiang, Master

Role: PRINCIPAL_INVESTIGATOR

Beijing Anding Hospital of Capital Medical University

Locations

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Beijing Anding Hospital of Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 41034820 (View on PubMed)

Other Identifiers

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031-403-00050

Identifier Type: -

Identifier Source: org_study_id