Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Forest Laboratories
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 be willing and able to provide written informed consent.
Each participant must have an identified external contact person or an identified responsible person.
Current diagnosis of Bipolar 1 Disorder, and a current manic (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision \[DSM-IV-TR\^TM\] code 296.4x) or mixed (DSM-IV code 296.6x) episode as determined by a structured clinical interview (Mini International Neuropsychiatric Interview \[MINI\]) at Screening.
Each participant must be confirmed to be experiencing an acute manic or mixed bipolar 1 episode.
You may not be if
Uncontrolled, unstable clinically significant medical condition.
Clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram findings at Screening.
Current primary Axis I disorder other than bipolar 1 disorder.
Meets the current DSM-IV-TR\^TM criteria for substance abuse or dependence (excluding nicotine).
Imminent risk of self-harm or harm to others.
Clareo Health | Efficacy and Safety of Asenapine in the Prevention of Recurrence of Mood Episodes in Participants With Bipolar 1 Disorder (P06384)
