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

Use our guide to learn which trials are right for you!

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
sites
Palo Alto, California
1328
mi
from
Palo Alto, CA
Click here to add this to my saved trials
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
569
mi
from
Houston, TX
Click here to add this to my saved trials
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...
808
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
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...
801
mi
from
Atlanta, GA
Click here to add this to my saved trials
Augusta, Georgia 30912
936
mi
from
Augusta, GA
Click here to add this to my saved trials
Beaumont, Texas 77701
571
mi
from
Beaumont, TX
Click here to add this to my saved trials
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,...
611
mi
from
Chicago, IL
Click here to add this to my saved trials
725
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Durham, North Carolina 27705
1047
mi
from
Durham, NC
Click here to add this to my saved trials
4572 Hagadorn Road
East Lansing, Michigan 48823
782
mi
from
East Lansing, MI
Click here to add this to my saved trials
Eugene, Oregon 97401
1382
mi
from
Eugene, OR
Click here to add this to my saved trials
Fall River, Massachusetts 02720
1437
mi
from
Fall River, MA
Click here to add this to my saved trials
Fort Lauderdale, Florida 33319
1307
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
Gainesville, Florida 32614
1049
mi
from
Gainesville, FL
Click here to add this to my saved trials
Granada Hills, California 91344
1177
mi
from
Granada Hills, CA
Click here to add this to my saved trials
Grand Rapids, Michigan 49503
737
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
Granite City, Illinois 62040
421
mi
from
Granite City, IL
Click here to add this to my saved trials
Huntingdon, Tennessee 38344
532
mi
from
Huntingdon, TN
Click here to add this to my saved trials
428
mi
from
Iowa City, IA
Click here to add this to my saved trials
Jacksonville, Florida 32209
1057
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Kalamazoo, Michigan 49048
718
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
Leesburg, Florida 34749
1106
mi
from
Leesburg, FL
Click here to add this to my saved trials
Longview, Texas 75601
402
mi
from
Longview, TX
Click here to add this to my saved trials
Manchester, New Hampshire 03101
1427
mi
from
Manchester, NH
Click here to add this to my saved trials
301 South Crapo Street
Mount Pleasant, Michigan 48858
793
mi
from
Mount Pleasant, MI
Click here to add this to my saved trials
Muskegon, Michigan 49433
722
mi
from
Muskegon, MI
Click here to add this to my saved trials
Nashua, New Hampshire 03060
1425
mi
from
Nashua, NH
Click here to add this to my saved trials
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...
262
mi
from
Omaha, NE
Click here to add this to my saved trials
230 East Ridgewood Avenue
Paramus, New Jersey 07652
1284
mi
from
Paramus, NJ
Click here to add this to my saved trials
3320 Rutger Street
Saint Louis, Missouri 63104
416
mi
from
Saint Louis, MO
Click here to add this to my saved trials
5000 Cedar Plaza Parkway
Saint Louis, Missouri 63128
407
mi
from
Saint Louis, MO
Click here to add this to my saved trials
4024 Central Avenue
Saint Petersburg, Florida 33711
1114
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
Salt Lake City, Utah 84105
779
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Antonio, Texas 78207
576
mi
from
San Antonio, TX
Click here to add this to my saved trials
Tallahassee, Florida 32308
924
mi
from
Tallahassee, FL
Click here to add this to my saved trials
Tucson, Arizona 85713
836
mi
from
Tucson, AZ
Click here to add this to my saved trials
West Palm Beach, Florida 33407
1280
mi
from
West Palm Beach, FL
Click here to add this to my saved trials
874
mi
from
Wooster, OH
Click here to add this to my saved trials
Worcester, Massachusetts 01605
1405
mi
from
Worcester, MA
Click here to add this to my saved trials