PK Study of Aripiprazole IM Depot for Chinese Patients With Schizophrenia

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

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

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Aripiprazole IM Depot

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100088
      • Beijing Anding Hospital of Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 62 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 400 mg group; Aripiprazole IM depot 400mg will be administered every four weeks for 20 weeks after drug switch / steady dose of oral aripiprazole tablets (each subject will receive 5 intramuscular injections totally).	Drug: Aripiprazole IM Depot; administration of Aripiprazole IM Depot formulation at doses of 400 mg for 5 times in patients with schizophrenia.; Other Names: ABILIFY MAINTENA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Adverse events will be examined by frequency, severity, seriousness, discontinuation, and relationship to treatment	up to 24 weeks
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive and Negative Symptoms Scale (PANSS)	To evaluate the change of Positive and Negative Symptoms Scale (PANSS) from baseline.	up to 24 weeks

Collaborators and Investigators

• Sponsor: Otsuka Beijing Research Institute
• Investigators: Principal Investigator: Tao Jiang, Master, Beijing Anding Hospital of Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2018
• Primary Completion (Actual): October 14, 2019
• Study Completion (Actual): October 14, 2019

Study Registration Dates

• First Submitted: September 11, 2017
• First Submitted That Met QC Criteria: September 14, 2017
• First Posted (Actual): September 18, 2017

Study Record Updates

• Last Update Posted (Actual): July 10, 2020
• Last Update Submitted That Met QC Criteria: July 9, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Aripiprazole
• Other Study ID Numbers: 031-403-00049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No