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

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Depressive Type, Schizophreniform Disorder

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Aripiprazole Lauroxil

ARI-ORAL

AL-NCD

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of California, Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AL-LAI: Long-Acting Injectable Antipsychotic

ARI-ORAL: Aripiprazole Oral Antipsychotic

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Exacerbation or relapse of positive psychotic symptoms

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

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

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.

Full Information

NCT ID

NCT04203056

First Posted

December 16, 2019

Last Updated

October 7, 2022

Sponsor

University of California, Los Angeles

Collaborators

Alkermes, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04203056

Brief Title

Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode

Acronym

APPRAISE

Official Title

Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Terminated

Why Stopped

Withdraw of financial support by industry collaborator

Study Start Date

December 16, 2019 (Actual)

Primary Completion Date

October 1, 2022 (Actual)

Study Completion Date

October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Los Angeles

Collaborators

Alkermes, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia, Schizoaffective Disorder, Depressive Type, Schizophreniform Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

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

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AL-LAI: Long-Acting Injectable Antipsychotic

Arm Type

Experimental

Arm Description

Arm Title

ARI-ORAL: Aripiprazole Oral Antipsychotic

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Aripiprazole Lauroxil

Other Intervention Name(s)

Aristada

Intervention Description

12 month longitudinal aripirprazole lauroxil treatment and assessment follow-through

Intervention Type

Drug

Intervention Name(s)

ARI-ORAL

Other Intervention Name(s)

aripiprazole, Abilify

Intervention Description

oral aripiprazole

Intervention Type

Drug

Intervention Name(s)

AL-NCD

Other Intervention Name(s)

Aristada Initio

Intervention Description

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

Primary Outcome Measure Information:

Title

Exacerbation or relapse of positive psychotic symptoms

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Role ratings on the Global Functioning Scale

Description

The groups will be compared on this measure of role functioning. Scores range from 1 to 10, with higher indicating better role functioning.

Time Frame

12 months

Title

Overall Composite T-score of the MATRICS Consensus Cognitive Battery

Description

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.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kenneth L Subotnik, PhD

Organizational Affiliation

University of California, Los Angeles

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California, Los Angeles

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode

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