A Clinical Study to Investigate the Effect of an Investigational Drug on Electrocardiogram Intervals in Adults With Schizophrenia.

Study Identifier:

SEP361-114

ClinicalTrials.gov Identifier:

NCT04369391

EudraCT Identifier:

N/A

EU CT ID:

N/A

Study Contact Information:

N/A

Study Complete

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Study Details

Medical Condition

Schizophrenia

Study Drug

Drug: SEP363856 150 mg
Drug: Placebo
Drug: moxifloxacin 400 mg

Date

Jun 2020 - Nov 2020

Phase 1/2

Phase 2/3

Phase 1

Phase 2

Phase 3

Phase 4

N/A

Patient Requirements

Sex: Female & Male

Age: 18 - 65 Years

Requirements Information

Inclusion and Exclusion Criteria

Inclusion Criteria

Male or female subject between 18 and 65 years of age, inclusive, at the time of informed consent
Subject must give written informed consent and privacy authorization prior to participation in the study
Subject meets DSM-5 criteria for a primary diagnosis of schizophrenia as established by clinical interview
Subject must have a CGI S score ≤ 4 at Screening
Subject must have a PANSS total score ≤ 80 at Screening
Subject must have a score of ≤ 4 on the following PANSS items at Screening:
P7 (hostility)
G8 (uncooperativeness)
Subject must have normal to mild symptoms on all individual items of the SAS (\< 2), AIMS (\< 3) and BARS (\< 3) at Screening
Subject must be clinically stable for the past three months in the opinion of the Investigator
Subject has been taking an antipsychotic for at least six weeks prior to Screening and has had no change in antipsychotic medication(s) for at least six weeks prior to Screening
Subject is, in the opinion of the Investigator, generally healthy based on Screening medical history, physical examination, neurological examination, vital sign measurement, electrocardiogram and clinical laboratory values

Exclusion Criteria

Subject has a DSM 5 diagnosis or presence of symptoms consistent with a DSM 5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder (within past 12 months), substance (other than nicotine or caffeine) use disorder within past 12 months, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms are not the primary focus of treatment
Subject tests positive for drugs of abuse or alcohol at Screening
Subject is at significant risk of harming him/herself or others (passive or active) according to the Investigator's judgment.
Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study
Female subject who is pregnant or lactating
Subject has any clinically significant abnormal laboratory value(s) at Screening as judged by the Investigator
Subject has an abnormal, clinically significant 12-lead ECG at screening
Subject has experienced significant blood loss (≥ 473 mL) or donated blood within 60 days prior to first dose of study drug; has donated plasma within 72 hours prior to the first dose of study drug or intends to donate plasma or blood or undergo elective surgery during study participation or within 60 days after the last study visit.
Subject has an abnormal, clinically significant 12-lead ECG at screening
Subject has a history of sick sinus syndrome, first, second, or third-degree AV block,myocardial infarction, NYHA Class II-IV heart failure, cardiomyopathy, pulmonary congestion, cardiac arrhythmia, prolonged QT interval, congenital long QT syndrome, family history of long QT, or moderate to severe hypokalemia

Protocol Summary

A clinical study to investigate the effect of an investigational drug in adults with schizophrenia by using Electrocardiogram (Picture of the electrical action of the heart). This study is accepting male and female participants between 18 years old -65 years old who have been diagnosed with schizophrenia. This study will be conducted in approximately 7 locations in the US. The study will last approximately 7 weeks.

Study Locations

Location

Status

Location

Woodland International Research Group

Little Rock, Arkansas, United States, 72211

Status

N/A

Location

Collaborative Neuroscience Research, LLC

Long Beach, California, United States, 90806

Status

N/A

Location

California Neuropsychopharmacology Clinical Research Institute-LA, LLC (CNRI-LA, LLC)

Pico Rivera, California, United States, 90660

Status

N/A

Location

California Neuropsychopharmacology Clinical Research Institute-San Diego, LLC (CNRI-SD, LLC)

San Diego, California, United States, 92101

Status

N/A

Location

Research Centers of America, LLC

Hollywood, Florida, United States, 33024

Status

N/A

Location

Hassman Research Institute

Marlton, New Jersey, United States, 08053

Status

N/A

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July 2025 01US25EUC0279

Requirements information

Inclusion criteria

Male or female subject between 18 and 65 years of age, inclusive, at the time of informed consent
Subject must give written informed consent and privacy authorization prior to participation in the study
Subject meets DSM-5 criteria for a primary diagnosis of schizophrenia as established by clinical interview
Subject must have a CGI S score ≤ 4 at Screening
Subject must have a PANSS total score ≤ 80 at Screening
Subject must have a score of ≤ 4 on the following PANSS items at Screening:
P7 (hostility)
G8 (uncooperativeness)
Subject must have normal to mild symptoms on all individual items of the SAS (\< 2), AIMS (\< 3) and BARS (\< 3) at Screening
Subject must be clinically stable for the past three months in the opinion of the Investigator
Subject has been taking an antipsychotic for at least six weeks prior to Screening and has had no change in antipsychotic medication(s) for at least six weeks prior to Screening
Subject is, in the opinion of the Investigator, generally healthy based on Screening medical history, physical examination, neurological examination, vital sign measurement, electrocardiogram and clinical laboratory values

Exclusion criteria

Subject has a DSM 5 diagnosis or presence of symptoms consistent with a DSM 5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder (within past 12 months), substance (other than nicotine or caffeine) use disorder within past 12 months, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms are not the primary focus of treatment
Subject tests positive for drugs of abuse or alcohol at Screening
Subject is at significant risk of harming him/herself or others (passive or active) according to the Investigator's judgment.
Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study
Female subject who is pregnant or lactating
Subject has any clinically significant abnormal laboratory value(s) at Screening as judged by the Investigator
Subject has an abnormal, clinically significant 12-lead ECG at screening
Subject has experienced significant blood loss (≥ 473 mL) or donated blood within 60 days prior to first dose of study drug; has donated plasma within 72 hours prior to the first dose of study drug or intends to donate plasma or blood or undergo elective surgery during study participation or within 60 days after the last study visit.
Subject has an abnormal, clinically significant 12-lead ECG at screening
Subject has a history of sick sinus syndrome, first, second, or third-degree AV block,myocardial infarction, NYHA Class II-IV heart failure, cardiomyopathy, pulmonary congestion, cardiac arrhythmia, prolonged QT interval, congenital long QT syndrome, family history of long QT, or moderate to severe hypokalemia

A Clinical Study to Investigate the Effect of an Investigational Drug on Electrocardiogram Intervals in Adults With Schizophrenia.

Study Details

Protocol Summary

Study Locations

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July 2025 01US25EUC0279