Trials / Terminated
TerminatedNCT04203056
Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- University of California, Los Angeles · Academic / Other
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Aripiprazole Lauroxil | 12 month longitudinal aripiprazole lauroxil treatment and assessment follow-through |
| DRUG | ARI-ORAL | oral aripiprazole |
| DRUG | AL-NCD | Aripiprazole Lauroxil 675 MG/2.4 ML Intramuscular Suspension, Extended Release |
Timeline
- Start date
- 2019-12-16
- Primary completion
- 2022-10-01
- Completion
- 2022-10-01
- First posted
- 2019-12-18
- Last updated
- 2023-11-28
- Results posted
- 2023-11-28
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04203056. Inclusion in this directory is not an endorsement.