TerminatedPhase 4

Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode

Stopped: Withdraw of financial support by industry collaborator

United States15 participantsStarted 2019-12-16

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Exacerbation or Relapse of Psychotic Symptoms

Timeframe: 12 months

Trial details

NCT IDNCT04203056

SponsorUniversity of California, Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-01

Results submitted2023-09-30

View on ClinicalTrials.gov More Schizophrenia trials

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria