Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode

NCT ID: NCT04203056

Last Updated: 2023-11-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-16
• Study Completion Date: 2022-10-01

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.

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

Schizophrenia; Schizoaffective Disorder, Depressive Type; Schizophreniform Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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). Note: These dosages are not assigned levels of the intervention and dosage levels may be changed at any time throughout the 12-month intervention based on clinical need and clinician judgement. Starting dosages do not indicate separate treatment conditions.

Group Type: EXPERIMENTAL

Aripiprazole Lauroxil

Intervention Type: DRUG

12 month longitudinal aripiprazole lauroxil treatment and assessment follow-through

AL-NCD

Intervention Type: DRUG

Aripiprazole Lauroxil 675 MG/2.4 ML Intramuscular Suspension, Extended Release

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.

Group Type: ACTIVE_COMPARATOR

ARI-ORAL

Intervention Type: DRUG

oral aripiprazole

Interventions

Aripiprazole Lauroxil

12 month longitudinal aripiprazole lauroxil treatment and assessment follow-through

Intervention Type: DRUG

ARI-ORAL

oral aripiprazole

Intervention Type: DRUG

AL-NCD

Aripiprazole Lauroxil 675 MG/2.4 ML Intramuscular Suspension, Extended Release

Intervention Type: DRUG

Other Intervention Names

Aristada; aripiprazole; Abilify; Aristada Initio

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alkermes, Inc.

INDUSTRY

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Kenneth L. Subotnik, PhD

Project Scientist, Adjunct Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kenneth L Subotnik, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

University of California, Los Angeles

Los Angeles, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PATS 20184225

Identifier Type: -

Identifier Source: org_study_id