NCT03287505

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 schizophrenia

Timeline
Completed

Started Jun 2017

Longer than P75 for phase_1 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

June 23, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 19, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2019

Completed
Last Updated

December 29, 2020

Status Verified

January 1, 2020

Enrollment Period

2.4 years

First QC Date

May 15, 2017

Last Update Submit

December 24, 2020

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • Adverse Events

    up to 20 weeks

  • Vital Signs

    up to 20 weeks

  • Laboratory Examination

    up to 20 weeks

Other Outcomes (1)

  • Positive and Negative Symptoms Scale (PANSS)

    up to 20 weeks

Study Arms (2)

Abilify IM Depot 300mg by once

EXPERIMENTAL

300 mg dose group: single-administration of Aripiprazole IM Depot (300 mg) in 12 subjects;

Drug: Aripiprazole IM Depot

Abilify IM Depot 400mg by once

EXPERIMENTAL

400 mg dose group: single-administration of Aripiprazole IM Depot (400 mg) in 12 subjects.

Drug: Aripiprazole IM Depot

Interventions

Aripiprazole IM DepotDRUG

administration of Aripiprazole IM Depot formulation at doses of 300 and 400mg once in patients with schizophrenia.

Also known as: ABILIFY MAINTENA
Abilify IM Depot 300mg by onceAbilify IM Depot 400mg by once

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects, and their legal representatives(or their guardian ), who have signed the informed consent form(ICF);
  • Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR (295.30, 295.10, 295.20,295.90 , 295.60);
  • 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.

You may not qualify if:

  • Patients who have other psychiatric disorders than schizophrenia based on diagnostic criteria of DSM-IV-TR;
  • Score of Positive and Negative Syndrome Scale (PANSS): ≥120;
  • Patients with a complication or a history of diabetic mellitus;
  • Subjects who are alcoholemia overdependent of drug, or have drug abuse history;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anding Hospital of Capital Medical University

Beijing, Beijing Municipality, 100088, China

Location

Related Publications (1)

  • Dong F, Wang F, Yuan X, Zhai Y, Uki M, Jiang T, Li A. Single- and multiple-dose pharmacokinetics, safety, and tolerability of Aripiprazole once-monthly, long-acting intramuscular injection for Chinese adults with schizophrenia. BMC Psychiatry. 2025 Oct 1;25(1):912. doi: 10.1186/s12888-025-07407-w.

    PMID: 41034820DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Tao Jiang, Master

    Beijing Anding Hospital of Capital Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2017

First Posted

September 19, 2017

Study Start

June 23, 2017

Primary Completion

November 8, 2019

Study Completion

November 8, 2019

Last Updated

December 29, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)