Status:
UNKNOWN
Treatment Study Comparing Aripiprazole Once Monthly With Standard of Care Medication in Outpatients With Schizophrenia
Lead Sponsor:
Matt Byerly
Collaborating Sponsors:
Otsuka America Pharmaceutical
Conditions:
Schizophrenia
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
This study compares aripiprazole once-monthly injection to standard of care oral antipsychotic medication in non-adherent outpatients with schizophrenia to see which treatment helps people take their ...
Eligibility Criteria
Inclusion
- Are able to provide written informed consent. If the Institutional Review Board (IRB) requires consent by a legally acceptable representative in addition to the subject, all required consents must be obtained prior to the initiation of any protocol-required procedure.
- Are 18 to 60 years of age, inclusive, at the time of informed consent
- Has a current diagnosis of schizophrenia, as defined by DSM-V criteria and a history of the illness for at least 6 months prior to screening from a reliable source (e.g., health care provider, family member, or medical records).
- Have been prescribed a single oral antipsychotic medication for at least 3 months prior to screening.
- Are able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, intramuscular (IM) once monthly injection, and discontinuation of prohibited concomitant medications, read and understand the written word in order to complete subject-reported outcomes measures, and be reliably rated on assessment scales.
- Are male and female subjects who are surgically sterile (i.e., have undergone orchiectomy or hysterectomy, respectively; female subjects who have been postmenopausal for at least 12 consecutive months; or male and female subjects who agree to remain abstinent or to practice double barrier forms of birth control from study screening through 30 days (for females) and 90 days (for males) from the last dose of study drug for SOC oral antipsychotics and 150 days for females and 180 days for males for aripiprazole once monthly. If employing birth control, two of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device, birth control pill, birth control implant, birth control once monthly injections, condom, or sponge with spermicide.
Exclusion
- Has a current DSM-V diagnosis other than schizophrenia, including schizophreniform disorder, schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, amnestic or other cognitive disorders. Also excluded are subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
- Has had a psychiatric hospitalization within the 30 days prior to screening.
- Has received a depot antipsychotic within the 6 months prior to screening.
- Is considered resistant or refractory to antipsychotic treatment by history (failed two prior antipsychotic medication studies) or response only to clozapine.
- Is taking two or more antipsychotics.
- Has a significant risk of violent behavior or a significant risk of committing suicide based on history or investigator's discretion.
- Has a history of seizures or any other medical condition that would expose the subject to undue risk or interfere with study assessments.
- Is involuntarily incarcerated or has been incarcerated in the past 6 months for any reason.
- Has undergone electroconvulsive therapy in the 2 years prior to enrollment in the study.
- Has used an investigational agent or has participated in a clinical study with aripiprazole once monthly or any other antipsychotic once monthly preparation within 30 days of screening.
- Has any medical condition that might preclude safe completion of the study (e.g., agranulocytosis, severe and unstable heart disease, AIDS, end-stage renal disease).
- Is taking a CYP3A4 inducer (e.g., carbamazepine).
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT02282085
Start Date
December 1 2014
Last Update
June 8 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390