Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode

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


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.


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.

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


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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Phone Email

Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note