PK Study of Aripiprazole IM Depot for Chinese Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

A Single-center, Uncontrolled, Open-label Clinical Trial Evaluating the Pharmacokinetic Characteristics and Safety of Aripiprazole IM Depot in Chinese Patients With Schizophrenia After Multi-dose Administration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03285503
• Other study ID #: 031-403-00049
• Status: Completed
• Phase: Phase 1
• Start date: August 17, 2018
• Est. completion date: October 14, 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 multi-administration of Aripiprazole IM Depot formulation at doses of 400mg in patients with schizophrenia.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 14, 2019
• Est. primary completion date: October 14, 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. Presence of other mental disorders than schizophrenia confirmed through diagnostic criteria of DSM-IV-TR;

2. Subjects who are alcoholomania or independent of drug, or have drug abuse history;

3. Positive for any of HIV antibody, HBsAg, HCV antibody and syphilis serology testing;

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 400 mg for 5 times 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 24 weeks
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	Adverse Events	Adverse events will be examined by frequency, severity, seriousness, discontinuation, and relationship to treatment	up to 24 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 24 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 24 weeks