APPRAISE: Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AL-LAI: Long-Acting Injectable Antipsychotic Patients successfully completing the Stabilization period will be randomized to one of the two medications groups: For patients assigned to the AL-LAI (aripiprazole lauroxil- long-acting injections), initiation of AL-LAI will begin with a one-day initiation regimen (using AL-NCD IM (aripiprazole lauroxil NanoCrystal Dispersion)). Subsequent dosing of AL-LAI will be flexible based on clinician judgment. Treatment with AL-LAI can be initiated at a dose of 441mg or 661mg (administered monthly), 882mg (administered monthly or every 6 weeks), or 1064mg (administered every 2 months). |
Drug: Aripiprazole Lauroxil
12 month longitudinal aripirprazole lauroxil treatment and assessment follow-through
Other Names:
Drug: AL-NCD
Aripiprazole Lauroxil 675 MG/2.4 ML Intramuscular Suspension, Extended Release
Other Names:
|
| Active Comparator: ARI-ORAL: Aripiprazole Oral Antipsychotic Patients successfully completing the Stabilization period will be randomized to one of the two medications groups: Patients assigned to the oral medication condition will continue with ARI-ORAL. ARI-ORAL dosage will be flexible and dosage will be at the discretion of the treating psychiatrist. Patients discontinuing ARI-ORAL study drug after Randomization to oral antipsychotic medication, can remain in active treatment and follow-up within the study, and may be prescribed any of a number of first-line oral antipsychotics. |
Drug: ARI-ORAL
oral aripiprazole
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Exacerbation or relapse of positive psychotic symptoms [12 months]
Time to first positive symptom exacerbation and/or relapse following a period of absence or relatively low levels of psychotic symptoms based on the expanded 24-item version of the Brief Psychiatric Rating Scale.
Secondary Outcome Measures
- Role ratings on the Global Functioning Scale [12 months]
The groups will be compared on this measure of role functioning. Scores range from 1 to 10, with higher indicating better role functioning.
- Overall Composite T-score of the MATRICS Consensus Cognitive Battery [12 months]
The groups will be compared on this standardized measure of cognition. T scores do not have an absolute minimum or maximum. Higher scores represent better cognition.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California, Los Angeles | Los Angeles | California | United States | 90095 |
Sponsors and Collaborators
- University of California, Los Angeles
- Alkermes, Inc.
Investigators
- Principal Investigator: Kenneth L Subotnik, PhD, University of California, Los Angeles
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PATS 20184225