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Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode

About

Brief 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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase IV

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
45 Years

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.
  • 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.

Join this Trial

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Study Stats
Protocol No.
19-000649
Category
Semel Institute (Psychiatry)
Principal Investigator
Kenneth Subotnik
Contact
Fe Asuan
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04203056
For detailed technical eligibility, visit ClinicalTrials.gov.