Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT02634320
Eligibility Criteria:
Inclusion Criteria:
* Has demonstrated tolerability to test doses of oral aripiprazole during screening; OR has a history of tolerated use of aripiprazole
* Has a diagnosis of schizophrenia
* Is clinically stable
* Has received at least 3 doses of risperidone long acting injection (Risperdal Consta) or paliperidone palmitate (Invega Sustenna) prior to screening.
* Has no antipsychotic medication regimen change for 4 weeks prior to Day 1
* Agreed to abide by the contraceptive requirements o the protocol
* Resides in a stable living situation
* Additional criteria may apply
Exclusion Criteria:
* Is currently pregnant or breastfeeding, or is planning to become pregnant during the study
* Has received Invega Trinza, aripiprazole lauroxil, or IM depot aripiprazole within 6 months of screening
* Has participated in a clinical trial involving any investigational product within the past 3 months, or is currently participating in a clinical trial involving an investigational product
* Has a positive urine drug test for illicit use of amphetamines, barbiturates, cocaine, methadone, opiates, phencyclidine at screening
* Additional criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02634320
Study Brief:
Protocol Section:
NCT02634320