Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode (NCT04203056) | Clinical Trial Compass
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 range18 Years – 45 Years
SexALL
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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.
✓. 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.