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:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-24 @ 5:12 PM
NCT ID:
NCT01658150
Eligibility Criteria:
Inclusion Criteria:
* Age 18-60
* DSM-IV schizophrenia or schizoaffective disorder diagnosis
* Residual phase of illness criteria met at screen and baseline as defined by item scores of equal to or less than 4 on each of the Brief Psychiatric Rating Scale (BPRS) hallucinatory behavior, unusual thought content, conceptual disorganization items
* Hamilton Rating Scale for Depression (HRSD) equal to or less than 12
* Baseline Clinician Administered Scale for Mania (CARS-M) score of less than 5
* Simpson Angus Scale (SAS) total score equal to or less than 6
* Treatment with at least one but no more than two stably-dosed second-generation antipsychotic medication (other than clozapine) for equal to or greater than 2 months and no changes planned over the 4-week study period
Exclusion Criteria:
* History of CNS trauma, neurological disorder, ADHD, mental retardation, learning disability, or other non-schizophrenic cause of cognitive impairment
* DSM-IV diagnosis of substance abuse/dependence within 3 months
* Pregnant women or women of childbearing age who are not using a medically accepted means of contraception
* Women who are breastfeeding
* Active, unstable medical problem that may interfere with cognition
* Current treatment for hypertension
* Uncontrolled hypertension
* Any drug known to interact with isradipine
* History of GI strictures
* History of heart disease
* Abnormal lab or ECG at screen
* Significant suicidal ideation at baseline (HRSD item 3\>2)
* ECT treatment within 12 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01658150
Study Brief:
Protocol Section:
NCT01658150