Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode

  • STATUS
    Recruiting
  • End date
    Jun 1, 2025
  • participants needed
    128
  • sponsor
    University of California, Los Angeles
Updated on 24 January 2021
psychosis
aripiprazole
schizophrenia
schizoaffective disorder
psychotic symptoms
schizophreniform disorder

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.

Description

This is a single-site 12-month open-label randomized study comparing the efficacy of the FDA-approved long-acting formulation of aripiprazole lauroxil to the efficacy of oral aripiprazole among patients with a recent onset of schizophrenia, schizophreniform, or schizoaffective (depressed) disorder. All assessments and treatment will take place at the UCLA Aftercare Research Program (300 UCLA Medical Plaza, Los Angeles, CA 90095), which is a program that specializes in the treatment and study of individuals with a recent onset of schizophrenia. The primary goal is to 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. All patients on oral medications will, at least initially, be treated with oral aripiprazole.

Details
Condition Psychosis, Schizophrenia, Schizophrenia and Schizoaffective Disorders, Schizophrenia and Schizoaffective Disorders (Pediatric), Schizoaffective Disorder, Depressive Type, schizophreniform disorder, schizophrenia disorders, Schizoaffective Disorder, Depressive Type
Treatment Aripiprazole Lauroxil, ARI-ORAL, AL-NCD
Clinical Study IdentifierNCT04203056
SponsorUniversity of California, Los Angeles
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 45 yrs?
Gender: Male or Female
Do you have any of these conditions: Schizophrenia or Psychosis or Schizoaffective Disorder, Depressive Type?
Do you have any of these conditions: Schizophrenia and Schizoaffective Disorders or Psychosis or schizophrenia disorders or Schizophrenia or schizophreniform disorder or Schizophrenia and...?
Is between 18 and 45 years of age, inclusive, at Screening
Has a diagnosis of schizophreniform disorder, schizophrenia, or schizoaffective disorder, depressed type
Has a first episode of a psychotic illness that occurred within the 24 months before entry
Fluency (oral and written) in the English language
Exhibits tolerability to ARI ORAL during the Stabilization period
Resides within commuting distance of the UCLA Aftercare Research Program in a stable living situation where the patient can be located
Agrees to abide by the contraceptive requirements of the protocol
Additional criteria may apply

Exclusion Criteria

Evidence of a known neurological disorder (e.g., epilepsy) or significant head injury
Premorbid IQ less than 70
Is currently pregnant or breastfeeding, or is planning to become pregnant during the study
Is currently on a long-acting injectable antipsychotic medication and it is clinically contra-indicated to switch to oral aripiprazole
History of poor or inadequate response to an adequate trial of oral or injectable aripiprazole
Has received AL-LAI or IM depot aripiprazole within two months prior to Randomization
Has alcohol or substance abuse as a prominent clinical problem or makes the primary diagnosis not possible to confirm
Is currently being treated with clozapine
Has participated in a clinical drug trial involving any drug within the past two months
Has a current DSM-5 diagnosis of bipolar disorder, or schizoaffective disorder, bipolar type, based on the screening SCID
Patient is an imminent danger to himself/herself
History of neuroleptic malignant syndrome, malignant hyperthermia, or clinically significant tardive dyskinesia
Additional criteria may apply
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