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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02901587
Enrollment
119
Registered
2016-09-15
Start date
2016-09-30
Completion date
2018-04-18
Last updated
2019-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizoaffective Disorder, Schizophrenia

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

Interventions

DRUGLu AF35700 (10 mg/day)

tablets for oral administration once daily

DRUGLu AF35700 (30 mg/day)

tablets for oral administration once daily

DRUGQuetiapine (Seroquel XR® 800 mg/day)

tablets for oral administration once daily

Sponsors

H. Lundbeck A/S
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change from time-matched baseline on day 1, 21, and 42 in QTcFBefore dose to 10 hours post dose

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026