Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Organon and Co
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Each participant must be at least 18 years of age
Male, or a female who is not of child-bearing potential or who is non-pregnant, non-lactating, and is using a medically accepted method of contraception
Each participant must have a current diagnosis of Bipolar I Disorder, current episode manic or mixed
Each participant must be confirmed to be experiencing an acute manic or mixed bipolar 1 episode
Each participant must have discontinued the use of all prohibited psychotropic medications
You may not be if
A participant must not have a primary Axis I disorder other than Bipolar 1 Disorder (i.e., an Axis 1 disorder other than Bipolar 1 Disorder that is primarily responsible for current symptoms and functional impairment)
A participant must not currently (within the past 6 months) meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR™) criteria for substance abuse or dependence (excluding nicotine)
A participant must not be at imminent risk of self-harm or harm to others, in the investigator's opinion based on clinical interview and responses provided on the Columbia Suicide Severity Rating Scale (CSSRS).
Clareo Health | Fixed-dose Safety and Efficacy Study of Asenapine for the Treatment of Acute Manic or Mixed Episode in Bipolar 1 Disorder (P05691)
