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:
NCT01804257
Eligibility Criteria:
Inclusion Criteria:
* Male or female ≥ 18 and ≤ 65 years of age
* Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria, by Structured Clinical Interview using DSM-IV SCID-I/P1, for either:
i. Bipolar disorder I, II, or Not Otherwise Specified (NOS), or ii. Schizophrenia or schizoaffective disorder
* Clinical global impression scale-severity (CGI-S) of 3 or below
* Currently on a stable regimen of oral antimanic or antipsychotic medication for at least 3 months
* No anticipation to change or titrate the regimen in the next 28 days
* Willingness to adhere to study procedures
* Capacity to provide informed consent
Exclusion Criteria:
* Pregnancy, or women of child bearing potential who are not using a medically accepted means of contraception
* Serious suicide or homicide risk, as assessed by evaluating clinician
* Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease
* DSM-IV diagnoses or symptoms of substance use disorders, active within the last 60 days
* A score of 3 or higher on the suspiciousness/paranoia item of the Brief Psychiatric Rating Scale (BPRS)
* Acute, clinically significant gastrointestinal symptoms, such as nausea, vomiting, abdominal pain, diarrhea, melena, or hematochezia
* History of significant gastrointestinal disease or major gastrointestinal surgery
* Clinical instability of any kind that, in the investigator's opinion, could preclude safe participation in the study
* Known allergies that could preclude safe participation in the study
* Current presence of an electronically active implanted medical device
* Participation in another medical device study, or on any investigational drug or device within the last 30 days
* Inability to obtain consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01804257
Study Brief:
Protocol Section:
NCT01804257