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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
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* Drug: Lu AF35700 (10 mg/day)
* Drug: Lu AF35700 (30 mg/day)
* Drug: Quetiapine (Seroquel XR® 800 mg/day)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lu AF35700 (10 mg/day)<br>Lu AF35700 10 mg/day for 6 weeks | Drug: Lu AF35700 (10 mg/day)<br>* tablets for oral administration once daily<br>|
| Experimental: Lu AF35700 (30 mg/day)<br>Lu AF35700 30 mg/day for 6 weeks | Drug: Lu AF35700 (30 mg/day)<br>* tablets for oral administration once daily<br>|
| Experimental: Quetiapine (Seroquel XR® 800 mg/day)<br>Quetiapine (Seroquel XR®) 800 mg/day for 6 weeks | Drug: Quetiapine (Seroquel XR® 800 mg/day)<br>* tablets for oral administration once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from time-matched baseline on day 1, 21, and 42 in QTcF |  | Before dose to 10 hours post dose |