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Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode

NCT04203056 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-11-28

Study results available
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Summary

This 12-month study will evaluate the efficacy of aripiprazole lauroxil compared to oral aripiprazole in preventing the re-emergence of psychotic symptoms in patients with a recent onset of schizophrenia.

Conditions

  • Schizophrenia
  • Schizoaffective Disorder, Depressive Type
  • Schizophreniform Disorder

Interventions

DRUG

Aripiprazole Lauroxil

12 month longitudinal aripiprazole lauroxil treatment and assessment follow-through

DRUG

ARI-ORAL

oral aripiprazole

DRUG

AL-NCD

Aripiprazole Lauroxil 675 MG/2.4 ML Intramuscular Suspension, Extended Release

Sponsors & Collaborators

Principal Investigators

  • Kenneth L Subotnik, PhD · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-16
Primary Completion
2022-10-01
Completion
2022-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04203056 on ClinicalTrials.gov