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

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ClinicalTrials.gov Identifier: NCT02901587
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: Lu AF35700 (10 mg/day) Drug: Lu AF35700 (30 mg/day) Drug: Quetiapine (Seroquel XR® 800 mg/day) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 2016
Actual Primary Completion Date : April 18, 2018
Actual Study Completion Date : April 18, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Quetiapine

Arm Intervention/treatment
Experimental: Lu AF35700 (10 mg/day)
Lu AF35700 10 mg/day for 6 weeks
Drug: Lu AF35700 (10 mg/day)
tablets for oral administration once daily

Experimental: Lu AF35700 (30 mg/day)
Lu AF35700 30 mg/day for 6 weeks
Drug: Lu AF35700 (30 mg/day)
tablets for oral administration once daily

Experimental: Quetiapine (Seroquel XR® 800 mg/day)
Quetiapine (Seroquel XR®) 800 mg/day for 6 weeks
Drug: Quetiapine (Seroquel XR® 800 mg/day)
tablets for oral administration once daily




Primary Outcome Measures :
  1. Change from time-matched baseline on day 1, 21, and 42 in QTcF [ Time Frame: Before dose to 10 hours post dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901587


Locations
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United States, California
US1104
Long Beach, California, United States
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com

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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT02901587     History of Changes
Other Study ID Numbers: 16323A
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs