Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode

NCT04203056 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: PATS 20184225
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizoaffective Disorder, Depressive Type; Schizophreniform Disorder

Outcome Measures

Primary Outcomes (1)

• Exacerbation or Relapse of Psychotic Symptoms

  Number of participants who experienced an exacerbation and/or relapse following a period of absence or relative low levels of psychotic symptoms based on the expanded 24-item version of the Brief Psychiatric Rating Scale

  12 months

Secondary Outcomes (2)

• Change in Role Ratings on the Global Functioning Scale From Baseline to 12 Months

  mean change from baseline to the 12 month point

• Change From Baseline to One-Year in the "MATRICS Consensus Cognitive Battery (MCCB)" Overall Composite T-Score.

  12 months

Study Arms (2)

AL-LAI: Long-Acting Injectable Antipsychotic

EXPERIMENTAL

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.

Drug: Aripiprazole Lauroxil; Drug: AL-NCD

ARI-ORAL: Aripiprazole Oral Antipsychotic

ACTIVE COMPARATOR

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

Interventions

Aripiprazole Lauroxil DRUG

12 month longitudinal aripiprazole lauroxil treatment and assessment follow-through

Also known as: Aristada

AL-LAI: Long-Acting Injectable Antipsychotic

ARI-ORAL DRUG

oral aripiprazole

Also known as: aripiprazole, Abilify

ARI-ORAL: Aripiprazole Oral Antipsychotic

AL-NCD DRUG

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

Also known as: Aristada Initio

AL-LAI: Long-Acting Injectable Antipsychotic

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Alkermes, Inc.: collaborator

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

aripiprazole lauroxil; Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Kenneth Subotnik, PhD
• Organization: University of California, Los Angeles

ksubotnik@mednet.ucla.edu

3108250334

Study Officials

• Kenneth L Subotnik, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Scientist, Adjunct Professor

Model Details: Randomized Controlled Trial; 12-month longitudinal follow-through study (anticipate enrolling at least 128 patients of whom 90 will be randomized to one of the two arms)

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 18, 2019
• Study Start: December 16, 2019
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: November 28, 2023
• Results First Posted: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)