Clareo Health | Study Investigating the Effect of Lu AF35700 on Cardiac Repolarization in Men and Women With Schizophrenia and Schizoaffective Disorder
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)
