Aripiprazole IM Depot for Chinese Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

Evaluation of Pharmacokinetics and Safety of Aripiprazole IM Depot Formulation by Single Administration in Chinese Patients With Schizophrenia: a Single-center, Uncontrolled, Open -Label Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03287505
• Other study ID #: 031-403-00050
• Status: Completed
• Phase: Phase 1
• Start date: June 23, 2017
• Est. completion date: November 8, 2019

Study information

• Verified date: January 2020
• Source: Otsuka Beijing Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 8, 2019
• Est. primary completion date: November 8, 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. 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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
China	Beijing Anding Hospital of Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Beijing Research Institute

Country where clinical trial is conducted

China, 

Outcome

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 20 weeks
Primary	Maximum Plasma Concentration	To assess the maximum Plasma Concentration (Cmax) of aripiprazole and its main metabolite OPC-14857	up to 20 weeks
Primary	Time of Maximum Concentration	To assess the time of Maximum Concentration (tmax) of aripiprazole and its main metabolite OPC-14857	up to 20 weeks
Primary	AUC0-8	To assess the area under the curve for period of medication, from 0 till infinity (AUC0-8) of aripiprazole and its main metabolite OPC-14857	up to 20 weeks
Primary	Apparent clearance after extravascular administration	To assess the Apparent clearance after extravascular administration (CL/F) of aripiprazole	up to 20 weeks
Secondary	Adverse Events	Adverse events will be examined by frequency, severity, seriousness, discontinuation, and relationship to treatment.	up to 20 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 20 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 20 weeks