Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode (APPRAISE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04203056
Recruitment Status : Recruiting
First Posted : December 18, 2019
Last Update Posted : August 17, 2021
Sponsor:
Collaborator:
Alkermes, Inc.
Information provided by (Responsible Party):
Kenneth L. Subotnik, PhD, University of California, Los Angeles

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
Schizophrenia Schizoaffective Disorder, Depressive Type Schizophreniform Disorder Drug: Aripiprazole Lauroxil Drug: ARI-ORAL Drug: AL-NCD 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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)
Masking: None (Open Label)
Masking Description: open label
Primary Purpose: Treatment
Official Title: Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode
Actual Study Start Date : December 16, 2019
Estimated Primary Completion Date : June 1, 2025
Estimated Study Completion Date : June 1, 2025


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 Name: Aristada

Drug: AL-NCD
Aripiprazole Lauroxil 675 MG/2.4 ML Intramuscular Suspension, Extended Release
Other Name: Aristada Initio

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:
  • aripiprazole
  • Abilify




Primary Outcome Measures :
  1. Exacerbation or relapse of positive psychotic symptoms [ Time Frame: 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 :
  1. Role ratings on the Global Functioning Scale [ Time Frame: 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.

  2. Overall Composite T-score of the MATRICS Consensus Cognitive Battery [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04203056


Contacts
Layout table for location contacts
Contact: Fe Asuan, MA (310) 206-3142 fasuan@mednet.ucla.edu
Contact: Keith H Nuechterlein, PhD (310) 206-3142 keithn@ucla.edu

Locations
Layout table for location information
United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Fe Asuan, MA    310-206-8980    fasuan@mednet.ucla.edu   
Contact: Keith H Nuechterlein, PhD    (310) 206-3142    keithn@ucla.edu   
Principal Investigator: Kenneth L Subotnik, PhD         
Sub-Investigator: Keith H Nuechterlein, PhD         
Sub-Investigator: Laurie R Casaus, MD         
Sub-Investigator: Margaret G Distler, MD         
Sponsors and Collaborators
University of California, Los Angeles
Alkermes, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Kenneth L Subotnik, PhD University of California, Los Angeles
Layout table for additonal information
Responsible Party: Kenneth L. Subotnik, PhD, Project Scientist, Adjunct Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04203056    
Other Study ID Numbers: PATS 20184225
First Posted: December 18, 2019    Key Record Dates
Last Update Posted: August 17, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Schizophrenia
Psychotic Disorders
Depressive Disorder
Depression
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Mood Disorders
Behavioral Symptoms
Aripiprazole
Aripiprazole lauroxil
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists