Comparison of a Long-acting Injectable Antipsychotic vs Clinician's Choice Early in Treatment to Break the Cycle of Relapse in Early Phase Schizophrenics

NCT ID: NCT02360319

Last Updated: 2020-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 489 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-11
• Study Completion Date: 2019-03-31

Brief Summary

The goal of this project is to show that the best possible option for preventing relapses in patients suffering from first episode (<1 year of anti-psychotic medication) or early phase (< 5 years of lifetime exposure to anti-psychotic medication) schizophrenia is by enhancing medication adherence. The study is designed to answer the question of whether the use of long-acting injectable (LAI) antipsychotics early in the course of treatment can break the cycle of frequent relapse that affects so many patients with early phase schizophrenia. The participating research sites (not individual patients) will be randomly assigned to either medication prescribed by their treating physician (with no restrictions) or to a regimen that involves a monthly long acting injectable antipsychotic. The sites will be assigned on a one to one basis to either of the arms taking into account types of patient population and geographical area. Patients enrolled in the study will participate in regular assessments either over the phone or in person and be followed for a period of 2 years. The primary outcome measure is time to first hospitalization.

Detailed Description

Approximately 40 U.S. sites will participate in the study in order to enroll approximately 500 patients over a year period. They will be recruited into two cohorts - the first episode cohort and the early phase (EP) cohort, with approximately 250 patients in each cohort. Enrollment of patients will be discontinued when the appropriate number for the target for each cohort is reached.

After providing written informed consent, patients will be screened for general eligibility by the clinical team at the site. Basic demographic data will be collected to determine suitability for inclusion into the study. The site will complete an information interview comprising data regarding symptomology and history, but the diagnosis of schizophrenia will fall to a centralized, remote blinded rater to enable consistency for eligibility.

Prescribers at sites in the clinician's choice arm can treat the patients in the manner most appropriate for that individual. Prescribers at sites in the Aripiprazole Once Monthly arm monthly will prescribe and administer the medication according to recommendations contained in the product labeling.

For a period of 2 years all subjects will receive bimonthly calls inquiring about visits to emergency rooms and hospitalization. At 4 month intervals information on use of services, insurance status, work, school attendance, and other service use outcomes will be assessed.

Conditions

Schizophrenia

Keywords

First episode or recent onset

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Aripiprazole Once Monthly

Aripiprazole long acting injectable formulation, 400mg per dose is to be administered once monthly. Clients in the study will be followed for 2 years

Group Type: EXPERIMENTAL

aripiprazole long acting injectable formulation

Intervention Type: DRUG

Clinician's Choice

Prescribers are not limited in the choice of treatment they can administer to their clients to alleviate the symptoms of schizophrenia. Any FDA approved antipsychotic agent can be used. Clients in the study wil be followed for 2 years

Group Type: ACTIVE_COMPARATOR

Any FDA approved antipsychotic agent

Intervention Type: DRUG

Investigators are free to choose the most appropriate treatment for their clients

Interventions

Any FDA approved antipsychotic agent

Investigators are free to choose the most appropriate treatment for their clients

Intervention Type: DRUG

aripiprazole long acting injectable formulation

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Are able to provide written informed consent Have a confirmed diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual (DSM) 5 criteria using the SCID (Structured Clinical Interview for DSM disorders) Are between the ages of 18 and 35, inclusive Have the following history with antipsychotic medications

1. First episode subjects: < 1 year of lifetime exposure to antipsychotic medication and only one episode of psychosis

2. EP subjects: between 1 year and 5 years of lifetime exposure to antipsychotic medication or subjects with < 1 year of lifetime antipsychotic medication and more than one episode of psychosis.

For LAI subjects: Must be willing to accept an injectable form of treatment

Exclusion Criteria

Have a current primary DSM-5 diagnosis other than schizophrenia, including schizophreniform disorder, schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, and amnestic or other cognitive disorders.

For LAI sites only - have a known allergy or intolerance to aripiprazole, or a past negative response to aripiprazole that is not explained by nonadherence Be pregnant or lactating Have any unstable medical condition that, in the opinion of the investigator, would be detrimental to the subject or would confound the results of the study Subjects in the MRI subset only- presence of any metal implants, pacemakers, irremovable prosthetic devices, or other devices or situations that may preclude imaging

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka America Pharmaceutical

INDUSTRY

Sponsor Role: collaborator

Vanguard Research Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John M Kane, M.D.

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

La Frontera

Tucson, Arizona, United States

San Fernando Mental Health Center

Granada Hills, California, United States

Stanford School of Medicine

Palo Alto, California, United States

Henderson Behavioral Health

Fort Lauderdale, Florida, United States

Meridian Behavioral Healthcare

Gainesville, Florida, United States

U. of Florida College of Medicine

Jacksonville, Florida, United States

LifeStream Behavioral Center

Leesburg, Florida, United States

Suncoast Center

St. Petersburg, Florida, United States

Apalachee Center, Inc.

Tallahassee, Florida, United States

Jerome Golden Center for Behavioral Health

West Palm Beach, Florida, United States

Grady Memorial Hospital

Atlanta, Georgia, United States

Augusta University

Augusta, Georgia, United States

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Chestnut Health Systems

Granite City, Illinois, United States

University of Iowa Psychiatry Research

Iowa City, Iowa, United States

Corrigan Mental Health Center

Fall River, Massachusetts, United States

U. Mass Medical School

Worcester, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Early Treatment and Cognitive Health

East Lansing, Michigan, United States

Cherry Street Health Services

Grand Rapids, Michigan, United States

WMU School of Medicine

Kalamazoo, Michigan, United States

Community Mental Health for Central Michigan

Mount Pleasant, Michigan, United States

Muskegon County Community Mental Health

Muskegon, Michigan, United States

Saint Louis University CRU

St Louis, Missouri, United States

PsychCare Consultants Research

St Louis, Missouri, United States

Creighton University

Omaha, Nebraska, United States

The Mental Health Center of Greater Manchester

Manchester, New Hampshire, United States

Healthy Perspectives

Nashua, New Hampshire, United States

New Bridge Medical Center

Paramus, New Jersey, United States

Carolina Behavioral Care

Durham, North Carolina, United States

Central Community Health Board of Hamilton Co.

Cincinnati, Ohio, United States

The Counseling Center of Wayne and Holmes Counties

Wooster, Ohio, United States

PeaceHealth Medical Group

Eugene, Oregon, United States

Carey Counseling Center

Huntingdon, Tennessee, United States

Spindletop Center

Beaumont, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

MHC Community Healthcore

Longview, Texas, United States

The Center for Health Care Services

San Antonio, Texas, United States

Psychiatric & Behavioral Solutions

Salt Lake City, Utah, United States

Countries

United States

References

Kane JM, Schooler NR, Marcy P, Correll CU, Achtyes ED, Gibbons RD, Robinson DG. Effect of Long-Acting Injectable Antipsychotics vs Usual Care on Time to First Hospitalization in Early-Phase Schizophrenia: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Dec 1;77(12):1217-1224. doi: 10.1001/jamapsychiatry.2020.2076.

Reference Type: DERIVED

PMID: 32667636 (View on PubMed)

Kane JM, Schooler NR, Marcy P, Achtyes ED, Correll CU, Robinson DG. Patients With Early-Phase Schizophrenia Will Accept Treatment With Sustained-Release Medication (Long-Acting Injectable Antipsychotics): Results From the Recruitment Phase of the PRELAPSE Trial. J Clin Psychiatry. 2019 Apr 23;80(3):18m12546. doi: 10.4088/JCP.18m12546.

Reference Type: DERIVED

PMID: 31050233 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

COL.AOM.2013.005

Identifier Type: -

Identifier Source: org_study_id