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

NCT02360319 | Completed Phase 4 Results DMC

• 1 other identifier: COL.AOM.2013.005
• Study Type: interventional
• Target: 489
• Locations: 1 country
• Sites: 39

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.

Conditions

Schizophrenia

Keywords

First episode or recent onset

Outcome Measures

Primary Outcomes (1)

• Time to First Hospitalization

  Assessments are done using best available data and patient interviews

  Hospitalizations assessed every 2 months from baseline to Month 24

Secondary Outcomes (4)

• Total Number of Psychiatric Hospitalizations Per Treatment Arm

  Measured every 2 months from baseline to month 24

• Brief Psychotic Rating Scale (BPRS) Total Score

  Measured at Month 12 and Month 24

• Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Sum of Scores

  Measured at Month 12 and Month 24

• Quality of Life (QLS) Total Score

  Measured at Month 12 and Month 24

Study Arms (2)

Clinician's Choice

ACTIVE COMPARATOR

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

Drug: Any FDA approved antipsychotic agent

Aripiprazole Once Monthly

EXPERIMENTAL

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

Drug: aripiprazole long acting injectable formulation

Interventions

Any FDA approved antipsychotic agent DRUG

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

Clinician's Choice

aripiprazole long acting injectable formulation DRUG

Aripiprazole Once Monthly

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanguard Research Group: lead
• Otsuka America Pharmaceutical: collaborator

Study Sites (39)

La Frontera

Tucson, Arizona, 85713, United States

Location

San Fernando Mental Health Center

Granada Hills, California, 91344, United States

Location

Stanford School of Medicine

Palo Alto, California, 94304, United States

Location

Henderson Behavioral Health

Fort Lauderdale, Florida, 33319, United States

Location

Meridian Behavioral Healthcare

Gainesville, Florida, 32614, United States

Location

U. of Florida College of Medicine

Jacksonville, Florida, 32209, United States

Location

LifeStream Behavioral Center

Leesburg, Florida, 34749, United States

Location

Suncoast Center

St. Petersburg, Florida, 33711, United States

Location

Apalachee Center, Inc.

Tallahassee, Florida, 32308, United States

Location

Jerome Golden Center for Behavioral Health

West Palm Beach, Florida, 33407, United States

Location

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Chestnut Health Systems

Granite City, Illinois, 62040, United States

Location

University of Iowa Psychiatry Research

Iowa City, Iowa, 52242, United States

Location

Corrigan Mental Health Center

Fall River, Massachusetts, 02720, United States

Location

U. Mass Medical School

Worcester, Massachusetts, 01605, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Early Treatment and Cognitive Health

East Lansing, Michigan, 48823, United States

Location

Cherry Street Health Services

Grand Rapids, Michigan, 49503, United States

Location

WMU School of Medicine

Kalamazoo, Michigan, 49048, United States

Location

Community Mental Health for Central Michigan

Mount Pleasant, Michigan, 48858, United States

Location

Muskegon County Community Mental Health

Muskegon, Michigan, 49433, United States

Location

Saint Louis University CRU

St Louis, Missouri, 63104, United States

Location

PsychCare Consultants Research

St Louis, Missouri, 63128, United States

Location

Creighton University

Omaha, Nebraska, 68131, United States

Location

The Mental Health Center of Greater Manchester

Manchester, New Hampshire, 03101, United States

Location

Healthy Perspectives

Nashua, New Hampshire, 03060, United States

Location

New Bridge Medical Center

Paramus, New Jersey, 07652, United States

Location

Carolina Behavioral Care

Durham, North Carolina, 27704, United States

Location

Central Community Health Board of Hamilton Co.

Cincinnati, Ohio, 45219, United States

Location

The Counseling Center of Wayne and Holmes Counties

Wooster, Ohio, 44691, United States

Location

PeaceHealth Medical Group

Eugene, Oregon, 97401, United States

Location

Carey Counseling Center

Huntingdon, Tennessee, 38344, United States

Location

Spindletop Center

Beaumont, Texas, 77701, United States

Location

Baylor College of Medicine

Houston, Texas, 77054, United States

Location

MHC Community Healthcore

Longview, Texas, 75601, United States

Location

The Center for Health Care Services

San Antonio, Texas, 78201, United States

Location

Psychiatric & Behavioral Solutions

Salt Lake City, Utah, 84105, United States

Location

Related Publications (2)

• 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.

  PMID: 32667636 DERIVED

• 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.

  PMID: 31050233 DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Patrica Marcy
• Organization: Vanguard Research Group

pmarcy@northwell.edu

3474398035

Study Officials

• John M Kane, M.D.

  Northwell Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2015
• First Posted: February 10, 2015
• Study Start: December 11, 2014
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: December 2, 2020
• Results First Posted: November 17, 2020

Record last verified: 2020-10

Locations

US (39)