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 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT01519557
Eligibility Criteria:
Inclusion Criteria:
* Males or females between 18 and 55 years old
* Fulfill Diagnostic and Statistical Manual, version 4 (DSM-IV) criteria schizophrenic illness, schizophreniform or schizoaffective disorder
* A negative urine toxicology
* Capacity to understand the study and to give written informed consent
* Must be on a stable dose of risperidone, aripiprazole, lurasidone, iloperidone, paliperidone, or haloperidol for at least 4 weeks if oral adn 2 cycles if depot. Absence of any antipsychotic medications other than risperidone, aripiprazole, or haloperidol for at least 4 weeks if oral or 2 cycles if depot prior to the study. Mood stabilizers, benzodiazepines and antidepressants are allowed as long as the drugs have not been changed for 4 weeks.
* Psychiatrically stable
Exclusion Criteria:
* Pregnancy or lactation, lack of effective birth control during the 15 days before the initial day of the study and for the duration of the drug trial
* Presence or positive history of severe medical or neurological illness, or any cardiovascular or liver disease
* Any current use of amphetamines, opiates, cocaine, sedative-hypnotics, cannabis, or other psychoactive drugs (other than nicotine)
* Metal implants or paramagnetic objects contained within the body which may interfere with MRI scan
* A history of substance dependence (other than nicotine or cannabis) or substance abuse within the previous 6 months (other than nicotine)
* Any current use of anticholinergic or anticoagulant medications. Any current use of any medications that can affect cognition or clotting other than occasional nonsteroidal antiinflammatory drug (NSAID)
* Impaired intellectual functioning
* Orthostatic hypotension
* BP systolic BP \<90 or \> 140 or diastolic BP \< 60 or \> 90
* Antipsychotic polypharmacy within the previous four weeks.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01519557
Study Brief:
Protocol Section:
NCT01519557