NCT03285503

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1 schizophrenia

Timeline
Completed

Started Aug 2018

Typical duration 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

September 11, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 18, 2017

Completed
11 months until next milestone

Study Start

First participant enrolled

August 17, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2019

Completed
Last Updated

July 10, 2020

Status Verified

January 1, 2020

Enrollment Period

1.2 years

First QC Date

September 11, 2017

Last Update Submit

July 9, 2020

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • Adverse Events

    up to 24 weeks

  • Vital Signs

    up to 24 weeks

  • Laboratory Examination

    up to 24 weeks

Other Outcomes (1)

  • Positive and Negative Symptoms Scale (PANSS)

    up to 24 weeks

Study Arms (1)

400 mg group

EXPERIMENTAL

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

Interventions

Aripiprazole IM DepotDRUG

administration of Aripiprazole IM Depot formulation at doses of 400 mg for 5 times in patients with schizophrenia.

Also known as: ABILIFY MAINTENA
400 mg group

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:

  • Presence of other mental disorders than schizophrenia confirmed through diagnostic criteria of DSM-IV-TR;
  • Subjects who are alcoholomania or independent of drug, or have drug abuse history;
  • Positive for any of HIV antibody, HBsAg, HCV antibody and syphilis serology testing;

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
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2017

First Posted

September 18, 2017

Study Start

August 17, 2018

Primary Completion

October 14, 2019

Study Completion

October 14, 2019

Last Updated

July 10, 2020

Record last verified: 2020-01

Locations

CN(1)