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 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT01808651
Eligibility Criteria:
Inclusion Criteria:
* Have completed Study B1Y-JE-HCLV (NCT#:NCT01808612)
* Agree to abstain from sexual activity or to use a reliable method of birth control
Exclusion Criteria:
* Significant suicidal risk
* Have a current or previous diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive disorder, or post-traumatic stress disorder
* Have a history of substance abuse or dependence within the past 6 months, excluding caffeine and nicotine
* Need to use thioridazine or pimozide during the study
* Have a positive urine drug screen for drugs with abuse potential
* Female participants who are either pregnant, nursing, or have recently given birth, or male participants who are planning for their partners to be or become pregnant
* Have frequent or severe allergic reactions to multiple medications
* Have a serious or unstable medical illness or condition, or psychological condition
* Participants deemed ineligible by the investigator or sub-investigator for other reasons
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01808651
Study Brief:
Protocol Section:
NCT01808651