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:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-25 @ 3:54 AM
NCT ID:
NCT00585702
Eligibility Criteria:
Inclusion Criteria for Bipolar Subjects:
* Age 18 or older
* Pregnant at 20 weeks or more
* Women must receive OB care
* English-speaking
* DSM-IV diagnosis of BP, any subtype
Inclusion Criteria for non-Bipolar Control Subject:
* Age 18 or older
* Pregnant at 20 weeks or more
* English-speaking
* Women must receive OB care.
* Women may have past or present subclinical Major Depressive Disorder according to the DSM-IV.
Exclusion Criteria for all:
* Women must have no Active Alcohol Abuse or Dependence, Active Abuse or Dependence of Opiates, Inhalants, Amphetamines including Ecstasy or LSD, Active IV Drug Abuse, or Methadone Maintenance.
* Women must not take drugs in the FDA categories D or X.
Additional Exclusion Criteria for Control Subjects:
* Women must have no lifetime history of Bipolar Disorder or antimanic drug use.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00585702
Study Brief:
Protocol Section:
NCT00585702