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 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
NCT ID:
NCT01584466
Eligibility Criteria:
Inclusion Criteria:
* Be between ages 18 and 64
* Either gender
* Any race
* Meet DSM-IV-TR criteria for Schizophrenia or Schizoaffective Disorder.
* Alcohol and/or cannabis use defined as a DSM-IV diagnosis abuse, dependence or regular use defined as 3 times per week during the past year
* Agree to take or use birth control during the study.
Exclusion Criteria:
* Previous lack of response or serious adverse event to risperidone or paliperidone.
* Currently on a long acting injectable antipsychotic.
* A score of less than 10 on the Evaluation to Sign Consent (ESC).
* Medical illnesses, which may compromise safe study participation.
* Pregnant and lactating females.
* QTc interval \> 450 milliseconds males or \> 470 milliseconds in females
* Currently on acamprosate, naltrexone and disulfiram.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT01584466
Study Brief:
Protocol Section:
NCT01584466