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 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT00841269
Eligibility Criteria:
Selection of Participants with Bipolar Disorder:
Inclusion Criteria:
* Participants must meet DSM-IV-TR (American Psychiatric Association, 2000) criteria for Bipolar Disorder Type I, Type II, or Not Otherwise Specified (NOS) with current mood state depressed for \> 2 weeks
* Participants must be between the age of 13 and 18 years
* Participants who enter the study on psychotropic medications must be on a regimen that has been stable for \> 2 weeks at the time of study entry
* Participants must be able to give informed consent or assent, and parent(s)/guardian(s) must be able to give informed permission for study participation
Exclusion Criteria:
* Adolescents with an unstable co-morbid medical, neurological, or psychiatric disorder
* Pregnant females, nursing mothers, or females of childbearing potential who are unable or unwilling to practice contraception during the study
* Participants with high risk of suicidal behaviors, homicidal behaviors, or self-harm
* Participants who in the opinion of the investigator are unlikely to be able to comply with the study protocol
* Participants who meet DSM-IV-TR criteria for current substance abuse or substance dependence, with the exception of nicotine abuse or dependence
* Participants for whom the MRI/MRS scans are contraindicated, such as children with ferromagnetic implants or claustrophobia
* Participants whose mood state is manic
* Documented or suspected history of mental retardation (IQ\<70)
* Positive urine drug screen for cocaine or amphetamines
* Known hypersensitivity to uridine
Selection of Healthy Volunteers:
Inclusion Criteria:
* Participants must be between the ages of 13 and 18 years
* Participants must not meet DSM-IV-TR diagnostic criteria for a mental disorder or substance abuse
* Participants must be able to give informed consent or assent and parents/guardians must be able to give informed permission for participation
Exclusion Criteria:
* Clinically significant medical, neurological, psychiatric or substance abuse disorder
* Pregnant subjects, due to the unknown effects of MRI/MRS scans on a fetus. In addition, women of childbearing potential who are unable or unwilling to practice contraception during the study will be excluded. Female participants who are of child-bearing potential must have a negative urine pregnancy test before each MRI/MRS scan.
* Participants with a contraindication to MRI/MRS scanning, such as a metallic implant
* Patients unable to comply with the protocol
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
18 Years
Study:
NCT00841269
Study Brief:
Protocol Section:
NCT00841269