Aripiprazole IM Depot for Chinese Patients With Schizophrenia

• Sponsor: Otsuka Beijing Research Institute (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03287505
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Actual Duration (Months): 28.5
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Aripiprazole IM Depot	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Jun 23, 2017
• Actual Primary Completion Date: Nov 8, 2019
• Actual Study Completion Date: Nov 8, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Maximum Plasma Concentration [up to 20 weeks]

   To assess the maximum Plasma Concentration (Cmax) of aripiprazole and its main metabolite OPC-14857

2. Time of Maximum Concentration [up to 20 weeks]

   To assess the time of Maximum Concentration (tmax) of aripiprazole and its main metabolite OPC-14857

3. 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

4. Apparent clearance after extravascular administration [up to 20 weeks]

   To assess the Apparent clearance after extravascular administration (CL/F) of aripiprazole

Secondary Outcome Measures

1. Adverse Events [up to 20 weeks]

   Adverse events will be examined by frequency, severity, seriousness, discontinuation, and relationship to treatment.

2. 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

3. 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).

Other Outcome Measures

1. Positive and Negative Symptoms Scale (PANSS) [up to 20 weeks]

   To evaluate the change of Positive and Negative Symptoms Scale (PANSS) from baseline.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Anding Hospital of Capital Medical University	Beijing	Beijing	China	100088

Sponsors and Collaborators

• Otsuka Beijing Research Institute

Investigators

• Principal Investigator: Tao Jiang, Master, Beijing Anding Hospital of Capital Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Otsuka Beijing Research Institute
• ClinicalTrials.gov Identifier: NCT03287505
• Other Study ID Numbers: 031-403-00050
• First Posted: Sep 19, 2017
• Last Update Posted: Dec 29, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Schizophrenia; Aripiprazole

Study Results

No Results Posted as of Dec 29, 2020