Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With Schizophrenia

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

295 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To assess the effectiveness of aripiprazole once-monthly in the maintenance treatment of patients with a diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR®), in a naturalistic care setting by comparing it to an existing long-acting antipsychotic, paliperidone palmitate.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Aripiprazole in the Treatment of Acutely Relapsed Patients With Schizophrenia

NCT00283179

Schizophrenia Schizoaffective Disorder

COMPLETED PHASE3

Efficacy & Safety Study of Oral Aripiprazole in Adolescents With Schizophrenia

NCT01149655

Schizophrenia

COMPLETED PHASE3

Aripiprazole Once-monthly in Patients With Schizophrenia

NCT01959035

Schizophrenia

COMPLETED PHASE3

Aripiprazole Once-monthly Versus Daily Oral Atypical Antipsychotic Treatment in Patients With Recent-onset Schizophrenia

NCT03130465

Schizophrenia

UNKNOWN

A Study of Adjunctive Treatment of Aripiprazole in Schizophrenic Patients

NCT00300846

Schizophrenia

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Aripiprazole and aripiprazole once-monthly

Group Type EXPERIMENTAL

Aripiprazole and aripiprazole once-monthly

Intervention Type DRUG

Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection at the end of Week 4. Oral tablets were taken for 2 more weeks after the 1st injection. Starting at the end of Week 8, additional injections were given every 4 weeks until Week 24.

Paliperidone and paliperidone palmitate

Group Type ACTIVE_COMPARATOR

Paliperidone and paliperidone palmitate

Intervention Type DRUG

Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by 2 paliperidone palmitate IM injections at Weeks 3 and 4, respectively. Starting at the end of Week 8, additional injections were given every 4 weeks until Week 24.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Aripiprazole and aripiprazole once-monthly

Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection at the end of Week 4. Oral tablets were taken for 2 more weeks after the 1st injection. Starting at the end of Week 8, additional injections were given every 4 weeks until Week 24.

Intervention Type DRUG

Paliperidone and paliperidone palmitate

Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by 2 paliperidone palmitate IM injections at Weeks 3 and 4, respectively. Starting at the end of Week 8, additional injections were given every 4 weeks until Week 24.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Aripiprazole: Abilify® Aripiprazole (extended-release injectable suspension): Abilify Maintena® Paliperidone: Invega® Paliperidone palmitate: Xeplion® or Invega® Sustenna®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* The patient has schizophrenia, diagnosed according to DSM-IV-TR®.
* The patient has a CGI-S score from mildly ill to markedly ill at the Screening and Baseline Visit(s).
* The patient is in need of a change in the current antipsychotic treatment and in the judgement of the investigator the patient would benefit from an extended treatment with a once-monthly formulation.
* The patient agrees to protocol-defined use of effective contraception.

Exclusion Criteria

* The patient has any current psychiatric disorder or Axis I disorder (DSM-IV® criteria) other than schizophrenia established as the primary diagnosis.
* The patient is experiencing acute exacerbation of psychotic symptoms at the Screening Visit or between the Screening and Baseline Visits.
* The patient in the investigator's judgment has shown significant intolerance and/or lack of efficacy to oral aripiprazole, paliperidone or risperidone.
* The patient is at significant risk of harming himself/herself or others according to the investigator's judgement or according to Columbia-Suicide Severity Rating Scale (C-SSRS).
* The patient has a history of neuroleptic malignant syndrome.
* The patient has or has had significant medical condition that would expose him or her to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the study including, but not limited to neurological, hepatic, renal, metabolic, haematological, immunological, gastrointestinal, pulmonary, or cardiovascular disorders.
* The patient has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study.
* The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No