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
Participants who have provided informed consent prior to any study specific procedures.
Participants currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder as confirmed by the Structured Clinical Interview (SCID) with a current with a current major depressive episode of at least 4 weeks and not exceeding 12 months in duration.
Participants with normal physical examination, laboratory, vital signs, and/or echocardiogram (ECG).
Verified previous manic or mixed episode.
Participants with a total Hamilton Rating Scale for Depression (HAMD)-17 score ≥ 20.
Participants with a HAMD-17 item 1 score ≥ 2.
Participants with a Clinical Global Impression of Severity (CGI-S) score ≥ 4.
You may not be if
Participants with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous 6 months.
Women who are pregnant or breast feeding
Participants with Young Mania Rating Scale (YMRS) total score \> 10
Participants who have dementia, mental retardation, schizophrenia/schizoaffective disorder.
Clareo Health | Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression
