Aripiprazole IM Depot for Chinese Patients With Schizophrenia

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Aripiprazole IM Depot

• Registration Number: NCT03287505
• Lead Sponsor: Otsuka Beijing Research Institute

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-05-15
• Study Start: 2017-06-23
• Study First Submitted QC: 2017-09-14
• Study First Posted: 2017-09-19
• Primary Completion: 2019-11-08
• Study Completion: 2019-11-08
• Status Verified: 2020-01
• Last Update Submitted: 2020-12-24
• Last Update Posted: 2020-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Abilify IM Depot 300mg by once	Aripiprazole IM Depot	300 mg dose group: single-administration of Aripiprazole IM Depot (300 mg) in 12 subjects;
Abilify IM Depot 400mg by once	Aripiprazole IM Depot	400 mg dose group: single-administration of Aripiprazole IM Depot (400 mg) in 12 subjects.

Primary Outcome Measures

Name	Time	Method
Apparent clearance after extravascular administration	up to 20 weeks	To assess the Apparent clearance after extravascular administration (CL/F) of aripiprazole
AUC0-∞	up to 20 weeks	To assess the area under the curve for period of medication, from 0 till infinity (AUC0-∞) of aripiprazole and its main metabolite OPC-14857
Maximum Plasma Concentration	up to 20 weeks	To assess the maximum Plasma Concentration (Cmax) of aripiprazole and its main metabolite OPC-14857
Time of Maximum Concentration	up to 20 weeks	To assess the time of Maximum Concentration (tmax) of aripiprazole and its main metabolite OPC-14857

Secondary Outcome Measures

Name	Time	Method
Adverse Events	up to 20 weeks	Adverse events will be examined by frequency, severity, seriousness, discontinuation, and relationship to treatment.
Laboratory Examination	up to 20 weeks	Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for routine laboratory tests (including prolactin).
Vital Signs	up to 20 weeks	Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for vital signs

Trial Locations

Locations (1)

Beijing Anding Hospital of Capital Medical University; 🇨🇳 Beijing, Beijing, China