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

Phase 1

Completed

• Conditions: Schizophrenia; Schizoaffective Disorder
• Interventions: Drug: Lu AF35700 (10 mg/day); Drug: Lu AF35700 (30 mg/day); Drug: Quetiapine (Seroquel XR® 800 mg/day)

• Registration Number: NCT02901587
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-12
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-15
• Primary Completion: 2018-04-18
• Study Completion: 2018-04-18
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-11
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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

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• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lu AF35700 (10 mg/day)	Lu AF35700 (10 mg/day)	Lu AF35700 10 mg/day for 6 weeks
Lu AF35700 (30 mg/day)	Lu AF35700 (30 mg/day)	Lu AF35700 30 mg/day for 6 weeks
Quetiapine (Seroquel XR® 800 mg/day)	Quetiapine (Seroquel XR® 800 mg/day)	Quetiapine (Seroquel XR®) 800 mg/day for 6 weeks

Primary Outcome Measures

Name	Time	Method
Change from time-matched baseline on day 1, 21, and 42 in QTcF	Before dose to 10 hours post dose

Trial Locations

Locations (1)

US1104; 🇺🇸 Long Beach, California, United States