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



Status:Active, not recruiting
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 35
Updated:2/7/2019
Start Date:December 11, 2014
End Date:August 31, 2019

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A Cluster Randomized, Multi-center, Parallel-group, Rater-blind Study Comparing Treatment With Aripiprazole Once Monthly and Treatment as Usual on Effectiveness in First Episode and Early Phase Illness in Schizophrenia

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.

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.

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
We found this trial at
39
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Worcester, Massachusetts 01605
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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80 Jesse Hill Jr Dr SE
Atlanta, Georgia 30303
(404) 616-1000
Grady Memorial Hospital Grady is an internationally recognized teaching hospital staffed exclusively by doctors from...
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Augusta, Georgia 30912
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Beaumont, Texas 77701
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303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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Durham, North Carolina 27705
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4572 Hagadorn Road
East Lansing, Michigan 48823
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Eugene, Oregon 97401
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Fall River, Massachusetts 02720
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Fort Lauderdale, Florida 33319
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Gainesville, Florida 32614
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Granada Hills, California 91344
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Grand Rapids, Michigan 49503
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Granite City, Illinois 62040
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Huntingdon, Tennessee 38344
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Iowa City, IA
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Jacksonville, Florida 32209
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Kalamazoo, Michigan 49048
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Leesburg, Florida 34749
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Longview, Texas 75601
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Manchester, New Hampshire 03101
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301 South Crapo Street
Mount Pleasant, Michigan 48858
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Muskegon, Michigan 49433
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Nashua, New Hampshire 03060
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2500 California Plaza
Omaha, Nebraska 68102
(402) 280-2700
Creighton University Creighton University, located in Omaha, Neb., offers a top-ranked education in the Jesuit...
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Palo Alto, California
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230 East Ridgewood Avenue
Paramus, New Jersey 07652
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3320 Rutger Street
Saint Louis, Missouri 63104
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5000 Cedar Plaza Parkway
Saint Louis, Missouri 63128
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4024 Central Avenue
Saint Petersburg, Florida 33711
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Salt Lake City, Utah 84105
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San Antonio, Texas 78207
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Tallahassee, Florida 32308
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Tucson, Arizona 85713
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West Palm Beach, Florida 33407
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