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 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT00488618
Eligibility Criteria:
Inclusion Criteria:
* Male or female inpatients 18 to 65 years of age
* Meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV) criteria for bipolar I disorder, acute manic or mixed episode
* Having a total Young Mania Rating Scale (YMRS) score \>= 20 and a score of at least 4 on two of the following YMRS items:
* Irritability,
* Speech,
* Content, and
* Disruptive/Aggressive Behavior
Exclusion Criteria:
* Patients who exhibit abnormalities on physical examination, have abnormal vital-signs, electrocardiogram (ECG), or clinical laboratory values \[such as thyroid-stimulating hormone (TSH)\].
* Patients with Montgomery-Åsberg Depression Rating Scale (MADRS) total score \>= 18 at Visit 2.
* Patients experiencing first manic episode.
* Patients that have received electroconvulsive therapy (ECT) or a depot neuroleptic in the 3 months prior to Visit 1.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00488618
Study Brief:
Protocol Section:
NCT00488618