Aripiprazole IM Depot for Chinese Patients With Schizophrenia

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

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

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 24
• 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: 18 years to 64 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. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abilify IM Depot 300mg by once; 300 mg dose group: single-administration of Aripiprazole IM Depot (300 mg) in 12 subjects;	Drug: Aripiprazole IM Depot; administration of Aripiprazole IM Depot formulation at doses of 300 and 400mg once in patients with schizophrenia.; Other Names: ABILIFY MAINTENA
Experimental: Abilify IM Depot 400mg by once; 400 mg dose group: single-administration of Aripiprazole IM Depot (400 mg) in 12 subjects.	Drug: Aripiprazole IM Depot; administration of Aripiprazole IM Depot formulation at doses of 300 and 400mg once 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	To assess the maximum Plasma Concentration (Cmax) of aripiprazole and its main metabolite OPC-14857	up to 20 weeks
Time of Maximum Concentration	To assess the time of Maximum Concentration (tmax) of aripiprazole and its main metabolite OPC-14857	up to 20 weeks
AUC0-∞	To assess the area under the curve for period of medication, from 0 till infinity (AUC0-∞) of aripiprazole and its main metabolite OPC-14857	up to 20 weeks
Apparent clearance after extravascular administration	To assess the Apparent clearance after extravascular administration (CL/F) of aripiprazole	up to 20 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 20 weeks
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
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

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 20 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): June 23, 2017
• Primary Completion (Actual): November 8, 2019
• Study Completion (Actual): November 8, 2019

Study Registration Dates

• First Submitted: May 15, 2017
• First Submitted That Met QC Criteria: September 14, 2017
• First Posted (Actual): September 19, 2017

Study Record Updates

• Last Update Posted (Actual): December 29, 2020
• Last Update Submitted That Met QC Criteria: December 24, 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: 031-403-00050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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