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
18–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Man or woman aged ≥18 years and ≤60 years with a body mass index (BMI) of ≥18.5 and ≤38 m2
Primary diagnosis of schizophrenia according to DSM-IV-TR™ (codes 295.10, 295.20, 295.30, 295.90)
Clinical Global Impression - Severity of Illness (CGI-S) score ≤4 (moderately ill) at the Screening Visit and Baseline Visit (Day -1)
PANSS total score ≤80 at the Screening Visit and the Baseline Visit (Day -1)
Score of 4 (moderate) of the following PANSS items at the Screening Visit and the Baseline Visit (Day -1): P7 (hostility), G8 (uncooperativeness)
Minimal level of extrapyramidal signs, defined as a score ≤5 (moderately severe) in any of the four Clinical Global Impression of Severity (CGI-S) items of the ESRS-A; parkinsonism, akathisia, dystonia, and tardive dyskinesia at the Screening Visit and the Baseline Visit
Willingness to be hospitalised for approximately 3 weeks after the Baseline Visit (Day -1)
You may not be if
The patient experienced an acute exacerbation requiring hospitalization within the last 6 months
The patient experienced an acute exacerbation requiring increase in antipsychotic medication (with reference to drug or dose) within the last 4 weeks
Clareo Health | Safety and Tolerability Study of Lu AF11167 After Repeated Dosing in Patients With Schizophrenia
