Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
H. Lundbeck A/S
Age
21–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
The patient is able by her/himself to provide informed consent to participate in the study
The patient has a primary diagnosis of schizophrenia or schizoaffective disorder (DSM-5™ criteria)
The patient has BMI ≤35 kg/m2
The patient has a Clinical Global Impression - Severity of Illness (CGI-S) score ≤4 (moderately ill)
PANSS total score ≤ 80 and a score ≤4 (moderate) on the PANSS items, P7 (hostility) and G8 (uncooperativeness)
The patient is willing to be hospitalized for up to 8 weeks
The patient is generally healthy based on medical history, physical examination, vital signs, ECG, and laboratory tests.
The patient agrees to protocol-defined use of effective contraception
You may not be if
The patient experienced acute exacerbation of psychosis requiring hospitalization within the last 3 months or required change in medication due to exacerbation of psychosis within the last 8 weeks
The patient has met moderate or severe co-morbid Substance Abuse Disorder DSM-5™ criteria in the last 3 months
The patient is at significant risk of harming her/himself or others in the opinion of the investigator or according to Columbia Suicide Severity Rating Scale (C-SSRS)
The patient has tested positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV)
Clareo Health | Study Investigating the Effect of Lu AF35700 on Cardiac Repolarization in Men and Women With Schizophrenia and Schizoaffective Disorder
