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 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT00812058
Eligibility Criteria:
Inclusion Criteria:
* Bipolar I Disorder, most recent episode depressed
* History of 2 or more manic or mixed episodes, at least one of which required pharmacologic treatment for manic symptoms
Exclusion Criteria:
* Current manic, hypomanic or mixed episode
* Rapid cycling bipolar disorder (4 or more mood episodes in the last year)
* Dementia or any other Axis I diagnosis (besides bipolar I) that requires treatment
* Alcohol or drug dependence within 6 months; alcohol or drug abuse within 3 months
* Positive urine drug test for amphetamines, cocaine metabolites, opiates and/or phencyclidine(PCP)
* Axis II diagnosis likely to interfere with study compliance
* Serious suicidal or homicidal risk
* Sensitivity to any of the drug ingredients, including lactose
* Women who are pregnant, breast feeding or refuse to use adequate birth control
* Current seizure disorder
* Current episode of depression is longer than 1 year
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00812058
Study Brief:
Protocol Section:
NCT00812058