Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Forest Laboratories
With
Gedeon Richter Ltd.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
