Trials Sponsors Conditions Drugs Pricing

Conditions

Antipsychotics Aripiprazole LAI Long-Acting Injection Schizophrenia

Keywords

aripiprazoleLong-Acting Injection

Outcome Measures

Primary Outcomes (1)

PANSS total score
Change in PANSS total score from baseline to Week 16
16 weeks

Secondary Outcomes (4)

CGI-S
16 weeks
CGI-I
16 weeks
PANSS positive and negative subscale score
16 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

Schizophrenia patients who are taking oral aripiprazole will be switched to Abilify maintena

Drug: Abilify maintena

Group 2

EXPERIMENTAL

Schizophrenia patients who are taking other oral atypical antipsychotics will be switched to Abilify maintena

Drug: Abilify maintena

Interventions

Abilify maintenaDrug

Switching from oral atypical antipsychotics to long-acting injectable aripiprazole (Abilify maintena)

Also known as: long-acting injectable aripiprazole

Group 1Group 2

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age19 Years - 64 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Subjects who voluntarily consented to participating in the clinical trial.
Male and female legally aged ≥19 and \< 65 years.

Sponsors & Collaborators

Korea Otsuka Pharmaceutical Co., Ltd.
Industrylead

Study Sites (27)

Gongju National Hospital

Gongju, Chungcheongnam-do, 32601, South Korea

Hanyang University Guri Hospital

Guri-si, Gyeonggi-do, South Korea

Cha Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

The Catholic University of Korea Uijeongbu ST. Mary'S Hospital

Uijeongbu-si, Gyeonggi-do, South Korea

Yong-In Mental Hospital

Yongin-si, Gyeonggi-do, 17089, South Korea

Jeju National University Hospital

Related Publications (10)

Aripiprazole Investigator Brochure, Version No. 20, 16 Aug 2016
BACKGROUND
Regier DA, Narrow WE, Rae DS, Manderscheid RW, Locke BZ, Goodwin FK. The de facto US mental and addictive disorders service system. Epidemiologic catchment area prospective 1-year prevalence rates of disorders and services. Arch Gen Psychiatry. 1993 Feb;50(2):85-94. doi: 10.1001/archpsyc.1993.01820140007001.
PMID: 8427558RESULT
Hong Kyu Ihm et al. Factors Related to Medication Adherence in Outpatients with Schizophrenia under More Than 5 Years of Treatment. J Korean Neuropsychiatr Assoc 2016; 55(4):397-406
RESULT

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

Jun Soo Kwon, Dr.
Seoul National University Hospital
PRINCIPAL INVESTIGATOR

Enrollment

201 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 13, 2017

First Posted

December 18, 2017

Study Start

November 21, 2017

Actual (reported)

You may not qualify if:

Subject who showed medically significant adverse events or intolerance with aripiprazole during screening period or as prior experiences.
Subjects with a current DSM diagnostic criteria-based diagnosis other than schizophrenia, including Schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, neurocognitive disorder due to Alzheimer's or similar diseases, amnesia, borderline, paranoid, histrionic, schizotypal, schizoid, antisocial or other cognitive or personality disorders.
Subjects with diseases of the central nervous system that may impact the assessment of the psychotic symptoms as per investigator's opinion.
Subjects who have been treated with clozapine, electroconvulsive therapy (ECT) or other long-acting injectable antipsychotic drugs within 3 months prior to the screening.
Subjects who have been treated more than 2 oral antipsychotic drugs (including both typical and atypical antipsychotic drugs) with the minimum therapeutic effective dose (as specified in each label) for schizophrenia treatment at screening.
(e.g. Aripiprazole≥10 mg/day, Olanzapine≥10 mg/day, Risperidone≥2 mg/day, Quetiapine ≥150 mg/day)
Subjects who have been treated with oral antipsychotic drugs (including both typical and atypical antipsychotic drugs) exceeding maximum maintenance dose (as specified in each label) at screening.
(e.g. Aripiprazole\>30 mg/day, Olanzapine\>20 mg/day, Risperidone \> 6 mg/day, Quetiapine \> 750 mg/day)
Subjects with a significant risk of violent behavior or a significant risk of committing suicide based on history or investigator's judgment.
Subjects had a history of seizures, neuroleptic malignant syndrome, clinically significant tardive dyskinesia, or other medical condition that would expose them to undue risk or interfere with study assessments.
Significant history of drug abuse disorder (excluding caffeine and nicotine, including alcohol, as defined in DSM-5 substance use disorder or in the opinion of the investigator) within the last 6 months prior to screening.
Subjects who participated in another interventional clinical trial within 30 days prior to screening.
Pregnant or lactating women, or women of childbearing potential who are not willing to or not able to use contraceptive methods (sexual abstinence; oral, implanted or injection hormone contraceptive methods; intrauterine device or condom; barrier contraceptive methods such as diaphragm and spermicide), accepted to avoid pregnancy until the end of the clinical trial.
Subjects having any other clinically significant finding of the physical examination or laboratory value that make investigator consider that it would be inappropriate to participate in this study.

MAintain the Efficacy and Safety in Treatment of Schizophrenia After Switching to Long-acTing Injectable aRipiprazole From Oral Atypical Antipsychotics

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Group 1

Group 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (27)

Related Publications (10)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Other Outcomes (4)

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Group 1

Group 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (27)

Related Publications (10)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Other Outcomes (4)

You may not qualify if:

Source record

Locations