Summary

Eligibility
for people ages 18-45 (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
Kenneth L Subotnik (ucla)

Description

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.

Details

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.

Keywords

Schizophrenia Schizoaffective Disorder, Depressive Type Schizophreniform Disorder Disease Psychotic Disorders Depressive Disorder Depression Aripiprazole Aripiprazole lauroxil ARI-ORAL AL-NCD AL-LAI: Long-Acting Injectable Antipsychotic ARI-ORAL: Aripiprazole Oral Antipsychotic

Eligibility

You can join if…

Open to people ages 18-45

  1. Is between 18 and 45 years of age, inclusive, at Screening.
  2. Has a diagnosis of schizophreniform disorder, schizophrenia, or schizoaffective disorder, depressed type.
  3. Has a first episode of a psychotic illness that occurred within the 24 months before entry.
  4. Fluency (oral and written) in the English language.
  5. Exhibits tolerability to ARI ORAL during the Stabilization period.
  6. Resides within commuting distance of the UCLA Aftercare Research Program in a stable living situation where the patient can be located.
  7. Agrees to abide by the contraceptive requirements of the protocol.
  8. Additional criteria may apply

You CAN'T join if...

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

Location

  • University of California, Los Angeles accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at UC Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT04203056
Phase
Phase 4
Study Type
Interventional
Last Updated