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 @ 10:59 PM
Ignite Modification Date:
2025-12-24 @ 10:59 PM
NCT ID:
NCT00015769
Eligibility Criteria:
INCLUSION CRITERIA:
Patients meeting DSM -IV criteria for bipolar I, bipolar II, bipolar NOS, and schizoaffective illness-bipolar type will be eligible for study. They will be enrolled in approved Protocol #97-M-0039 and thus will not have H.I.V. and will have provided consent for all of the rating forms utilized in this study.
Patients with inadequate response to two standard agents (i.e., lithium, valproate, carbamazepine, or neuroleptics) in the treatment of bipolar illness will be eligible for open adjunctive levetiracetam.
If serum creatinine is above normal, a creatinine clearance will be preformed; this must be above 85 in order for a patient to be eligible for this study.
EXCLUSION CRITERIA:
Women of child-bearing age who are not on an active method of birth control or who are likely to become pregnant will be excluded.
Men or women with significant renal disease will also be excluded.
For the depressed phase, patients will have an IDS score of 18 or greater, an LCM depression score of low moderate or greater, and a GCI-BP severity score of moderate or greater for more than 2 weeks, i.e., the DSM-IV durational criteria.
For the hypomanic/manic phase, patients will have an YMRS score of 8 or greater, an LCM mania rating of mild or greater, and a CGI-BP severity score of moderately ill or greater for 7 days or more.
Those in the cycling group would meet the severity criteria for depression and mania. They would have four or more mood "switches," and have an overall illness rating on the CGI-BP severity score of moderate or greater.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00015769
Study Brief:
Protocol Section:
NCT00015769