CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 295 enrolled
Drug / intervention
Aripiprazole and aripiprazole once-monthly +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01795547
NCT01795547Phase 3Completed
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A 28-week, Randomised, Open-label Study Evaluating the Effectiveness of Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With Schizophrenia

H. Lundbeck A/S·interventional·Posted Feb 20, 2013·Updated Mar 17, 2017

In Brief

A Phase 3 clinical trial evaluating Aripiprazole and aripiprazole once-monthly and Paliperidone and paliperidone palmitate for Schizophrenia. Completed, enrolled 295 participants across 2 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
CollaboratorsOtsuka Pharmaceutical Co., Ltd.

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 20, 2013
Enrollment StartFeb 1, 2013
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 13.4 years ago

Interventions

Aripiprazole and aripiprazole once-monthlydrug

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 palmitatedrug

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.