Study Investigating the Effect of Lu AF35700 on Cardiac Repolarization in Men and Women With Schizophrenia and Schizoaffective Disorder
Status: | Completed |
---|---|
Conditions: | Schizophrenia, Psychiatric |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 21 - 60 |
Updated: | 4/25/2018 |
Start Date: | September 2016 |
End Date: | April 18, 2018 |
Interventional, Randomised, Double-blind, Parallel-group, Active-control, Multiple-dose Study Investigating the Effect of Lu AF35700 on Cardiac Repolarization in Men and Women With Schizophrenia and Schizoaffective Disorder
The purpose of this study is to investigate the effect of Lu AF35700 on electrical activity
in the heart as measured on an electrocardiogram (ECG) in patients with schizophrenia or
schizoaffective disorder after 6 weeks of treatment
in the heart as measured on an electrocardiogram (ECG) in patients with schizophrenia or
schizoaffective disorder after 6 weeks of treatment
Inclusion Criteria:
- 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
Exclusion Criteria:´
- 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)
Other protocol defined inclusion and exclusion criteria may apply
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