A Trial in Adult Subjects With Schizophrenia Treated Prospectively for 6-months With Abilify MyCite®
A Phase IIIb Multi-Center, Open-Label, Mirror-Image, Trial in Adult Subjects With Schizophrenia Treated Prospectively for 6-months With Abilify MyCite®
Status
Recruiting
Start date
04/29/2019
Healthy
No
Contact
Denise Fox
617-460-3028
denise.fox@quintiles.com
Age
18 Years
— 65 Years
Gender
All
Summary
To compare inpatient psychiatric hospitalization rates while subjects are on oral standard-of-care antipsychotic treatment and later switched to Abilify MyCite. This trial will include male and female subjects who are 18 to 65 years old and diagnosed with schizophrenia. The trial will be conducted at 75 sites in the United States, with the a target of enrolling 320 subjects. Subject participation is approximately 8 months, including a 45-day screening period, a required 3 months (Months 1 to 3) of Abilify MyCite treatment. This will be followed to either a change back to standard-of-care antipsychotic treatment or remain on Abilify MyCite for an additional 3 months (Months 4-6). All subjects who complete or withdraw from the trial while on Abilify MyCite will receive a telephone call for safety follow-up approximately 30 days after their last trial visit.
Overview
This is a phase 3b, open-label, prospective, clinical trial designed to assess the difference between inpatient psychiatric hospitalization rates in subjects on oral standard-of-care antipsychotic treatment(s) for a period of 6 months followed by a switch to Abilify MyCite for a period of 3 months (Months 1 to 3). At the Month 3 visit, the investigator should decide if subjects will continue on Abilify MyCite for an additional 3 months (Months 4 to 6) or switch to a standard-of-care treatment for the duration of treatment. This trial will include male and female subjects who are 18 to 65 years of age, inclusive, with a diagnosis of schizophrenia. Subjects must have had at least 1 inpatient psychiatric hospitalization within 4 years (48 months) and must have been prescribed oral antipsychotics for at least 6 months or longer prior to screening. Subjects will enter a screening period (up to 45 days). If deemed eligible to participate, subjects will enter an open-label Abilify MyCite treatment prospective phase for up to 6 months. All subjects who complete or withdraw from the trial while on Abilify MyCite will receive a telephone call for safety follow-up approximately 30 days after their last trial visit. The trial will be conducted at 75 sites in the United States, 493 subjects will be screened in order to enroll 320 subjects and complete 224 subjects.
Eligibility Criteria
Inclusion Criteria:
Subject must be willing and able to give written informed consent, adhere to trial procedures and able to read and understand English.
Male and female subjects 18 to 65 years of age
Subject must possess a smartphone and is familiar with its use and is willing to download and interact with the Abilify MyCite app. A subject with a smartphone that is not compatible with the Abilify MyCite app will be offered a loaner phone for the trial period.
Clinical diagnosis of schizophrenia and able to ingest oral medication
Positive and Negative Syndrome Scale (PANSS) total score between 60-90.
Subjects currently prescribed oral atypical antipsychotic medication including aripiprazole or appropriate for aripiprazole treatment for 6 months or longer.
Subjects are required to have had an inpatient hospitalization for schizophrenia within the last 48 months prior to entering the trial.
Skin on the anterior chest just above the lower edge of the rib cage that is free of any dermatological problems
Exclusion Criteria:
Females who are breast-feeding and/or who are pregnant
Sexually active males or women of childbearing potential (WOCBP) who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of Abilify MyCite.
Any subject who participated in another clinical trial within 30 days of enrollment
Subjects who are currently being treated with an LAI antipsychotic or have been treated with an LAI in the retrospective 6-month phase.
Subjects with a current DSM-5 diagnosis other than schizophrenia
Subject with a known allergy to adhesive tape or any pertinent components of the patch or aripiprazole tablet embedded with an IEM sensor
Anaheim, California 92805 Recruiting
Jeannine Rosete
714-999-6688
jrosete@arctrials.com
Steven Macina
Phoenix, Arizona 85012 Recruiting
Alyssa McKinney
602-562-7000
amckinney@alearesearchphoenix.com
Jelena Kunovac
Lincoln, Nebraska 68526 Recruiting
Las Vegas, Nevada 89102 Recruiting
Hoffman Estates, Illinois 60169 Recruiting
Maureen Ganser
847-230-3992
maureen.ganser@amitahealth.org
Constantin Abuzatoaie
Saint Louis, Missouri 63118 Recruiting
Bertina Wilson
314-230-4326
bwilson@archclinicaltrials.com
Junaid Syed
San Diego, California 92103 Recruiting
Houston, Texas 77030 Recruiting
Uzma Khalid
713-873-5145
ukhalid@bcm.edu
Asim Shah
Glendale, California 91206 Recruiting
Tristan Biley
888-255-5798
tristan@brstrials.com
Jesse Carr
Miami, Florida 33133 Recruiting
Maria Gallagher
305-285-0705
maria@ccmclinicalresearch.com
Francisco Ricart
Garfield Heights, Ohio 44125 Recruiting
Martin Manuel
216-587-6727
mmanuel@charakresearch.com
Rakesh Ranjan
Santa Ana, California 92705 Recruiting
Debra Hoffmeyer
949-338-9258
debra@citrials.com
Dennis Alters
Bellflower, California 90706 Recruiting
Jonathan Barber
714-542-3008
jbarber@syrentis.com
Evagelos Coskinas
Pico Rivera, California 90660 Recruiting
San Diego, California 92102 Recruiting
Garden Grove, California 92845 Recruiting
Austin, Texas 78754 Recruiting
Isha Bal
512-597-6715
isha.bal@communityclinical.com
David Brown
Oklahoma City, Oklahoma 73116 Recruiting
Liz Thompson
405-603-8068
lthompson@cuttingedgeresearch.org
Willis Holloway
Decatur, Georgia 30030 Recruiting
Casey Chacona
404-537-1282
casey.chacona@iresearchatlanta.com
David Purselle
Oceanside, California 92056 Recruiting
Joshua Townsend
760-758-2222
jtownsend@excellresearch.com
Sherry Soefje
Rochester, New York 14618 Recruiting
Sarah Northup
585-241-9670
snorthup@flclinical.com
Sarah Atkinson
Hialeah, Florida 33016 Recruiting
Luis Pedraza
305-805-0921
luiusp@galizresearch.com
Jose Gamez
Berlin, New Jersey 08009 Recruiting
Hialeah, Florida 33012 Recruiting
Ricardo Vega
305-825-6588
rvega@indagoresearch.org
Miguel Perez
Lauderhill, Florida 33319 Recruiting
Orbrena Wellons, MA
954-990-6326
owellons@segaltrials.com
Rishi Kakar
DeSoto, Texas 75115 Recruiting
Kyle West
972-420-1484
kwest@incr.us
Suresh Sureddi
Las Vegas, Nevada 89109 Recruiting
Monique Myles
702-910-7213
moniquem@calpsychservices.com
Akindele Kolade
Lake Charles, Louisiana 70629 Recruiting
Kami Mallett
337-564-6405
kmallett@lcct.us
Kashinath Yadalam
New York, New York 10036 Recruiting
Anton Storozhenko
646-678-4073
anton@nymbm.com
Judith Joseph
Ann Arbor, Michigan 48105 Recruiting
Mohammad Al-Matarenh
734-834-8954
m.matarneh78@gmail.com
Rajaprabhakaran Rajarethinam
Dayton, Ohio 45417 Recruiting
Rebecca Vernon
937-424-1050
rvernon@ergclinical.com
Otto Dueno
Canton, Ohio 44718 Recruiting
Camille Settles
330-493-1118
csettles@nb-cr.com
Shishuka Malhotra
Hialeah, Florida 33012 Recruiting
Viviana Dobal
754-360-3750
dobal@newlifemedresearch.com
Lourdes Selem
Springville, Utah 84663 Recruiting
Seneca Anderson
801-369-8989
seneca@cedarpsychiatry.com
Reid Robison
Bellevue, Washington 98007 Recruiting
Winter Park, Florida 32789 Recruiting
Carmen Torres
407-718-3530
cjtorre23@gmail.com
David Medina
Oakland, California 94607 Recruiting
Shawna Cote
510-444-2877
shawnacote@pacifictrials.com
Corinna Gamez
Bentonville, Arkansas 72712 Recruiting
Iliana Maldonado
214-396-4844
imaldonado@pillarhc.com
Scott Bartley
Miami, Florida 33122 Recruiting
Juliet Perez
305-392-0279
jperez@pcrinstitute.com
Emilio Mantero-Atienza
Miami, Florida 33133 Recruiting
Naty Diaz
305-907-6960
naty@pcresearchcenter.com
Patricia Junquera
Culver City, California 90230 Recruiting
Rancho Cucamonga, California 91730 Recruiting
Omar Barnett
626-414-7902
obarnett@prospectiveinn.com
Gilbert Martinez
Saint Louis, Missouri 63128 Recruiting
Syed Zaidi
314-849-1853
syed.zaidi@pccresearch.org
Mohd Malik
Franklin, Tennessee 37067 Recruiting
Jessica Frazer
615-807-4023
jessica@psyconsults.com
James Hart
Staten Island, New York 10312 Recruiting
Jane Gorman
718-317-5522
gorman@rbany.com
Mark DiBuono
Granada Hills, California 91344 Recruiting
Richard Franco
818-832-6160
rfluna@dmh.lacounty.gov
Alex Kopelowicz
Gainesville, Florida 32607 Recruiting
Carole Newell
352-333-0094
carole@ehsfamily.com
Elias Sarkis
Scranton, Pennsylvania 18503 Recruiting
Abraham Gonzales
570-208-1088
agonzales@gminstitutes.com
Sanjay Chandragiri
Fairlawn, Ohio 44333 Recruiting
Carl Faust
330-835-4000
faust.carl@yahoo.com
Anand Chaturvedi
Santa Rosa, California 95401 Recruiting
Amanda Anello
707-696-8045
aanello@siyanclinical.com
Anish Shah
Tampa, Florida 33613 Recruiting
Susan Fowler
813-971-8311
susan_fowler@stedmanclinicaltrials.com
Mary Stedman
Downingtown, Pennsylvania 19335 Recruiting
Mathew Gitlin
610-891-9024
mgitlin@suburbanresearch.com
Shivkumar Hatti
National City, California 91950 Recruiting
Cerritos, California 90703 Recruiting
Atlanta, Georgia 30328 Recruiting
Bonne Raufman
404-255-6005
bonnie.raufman@synexus-us.com
Bethany Davis
Jamaica, New York 11432 Recruiting
Nancy Cano
718-969-3005
nancy.cano@synexus-us.com
Aggy Vallanat
Oklahoma City, Oklahoma 73112 Recruiting
Heather Horstkoetter
405-753-4994
heather@rivusinstitute.com
Marvin Peyton
Chicago, Illinois 60640 Recruiting
Little Rock, Arkansas 72211 Recruiting
Riley Neal
501-221-8681
rneal@ergclinical.com
Jim Aukstuolis