SchizophreniaPhase 1NCT04369391
A Clinical Study to Investigate the Effect of an Investigational Drug on Electrocardiogram Intervals in Adults With Schizophrenia.
A Phase 1 study testing SEP363856 150 mg and moxifloxacin 400 mg in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- SEP363856 150 mg and moxifloxacin 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 7 sitesUnited States
- Study dates
- 18 Jun 2020to 10 Nov 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Community Clinical Research Inc. Austin, TX 78754
Austin, Texas, 78754
Research Centers of America, LLC
Hollywood, Florida, 33024
Woodland International Research Group
Little Rock, Arkansas, 72211
Collaborative Neuroscience Research, LLC
Long Beach, California, 90806
Hassman Research Institute
Marlton, New Jersey, 08053
California Neuropsychopharmacology Clinical Research Institute-LA, LLC (CNRI-LA, LLC)
Pico Rivera, California, 90660
California Neuropsychopharmacology Clinical Research Institute-San Diego, LLC (CNRI-SD, LLC)
San Diego, California, 92101
About this study
Official title: A Randomized, Single-dose, Crossover Study of the Effects of SEP-363856 on Electrocardiogram (ECG) Intervals in Subjects With Schizophrenia
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.
Read the detailed description
This is a Phase 1, randomized, single-dose, active and placebo controlled, 3-period crossover study of the effect of SEP-363856 150 mg on electrocardiogram (ECG) intervals in subjects with schizophrenia. SEP-363856 and matching placebo will be utilized in a double-blind fashion. Moxifloxacin will be utilized as an active control in an open-label fashion.
The primary analysis will be based on concentration-QTc modeling of the relationship between plasma concentrations of SEP-363856 or its metabolite SEP-363854 and change-from baseline QTc.
- Conditions
- Schizophrenia
- Being tested
- SEP363856 150 mg, Placebo, moxifloxacin 400 mg
- Keywords
- schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEP363856 150 mgDrug
SEP363856 tablet 150 mg
PlaceboDrug
Placebo tablet
moxifloxacin 400 mgDrug
moxifloxacin tablet 400 mg
| Study group | Role | What they receive |
|---|---|---|
| SEP363856 150 mg | Experimental | SEP363856 tablet 150 mg Receives: Drug: SEP363856 150 mg |
| Placebo | Placebo comparator | matched placebo Receives: Drug: Placebo |
| moxifloxacin 400 mg | Active comparator | moxifloxacin tablet 400 mg Receives: Drug: moxifloxacin 400 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placebo-adjusted change-from-baseline QTc interval (ΔΔQTc)
Measured: 24 Hours
Secondary outcomes (7)
Change from baseline in heart rate, QTcF, pulse rate, and QRS intervals (∆HR, ΔQTcF, ΔPR, and ∆QRS)
Measured: 24 Hours
If a substantial heart rate (HR) effect is observed: Change from baseline in QTcS, QTcI, and QTcP (ΔQTcS, ΔQTcI, and ΔQTcP)
Measured: 24 Hours
Placebo-adjusted change from baseline in heart rate, pulse rate, and QRS intervals (ΔΔHR, ΔΔPR, and ΔΔQRS)
Measured: 24 Hours
If a substantial heart rate (HR) effect is observed: Placebo-adjusted ΔQTcS, and/or ΔQTcI, and/or ΔQTcP, and/or ΔQTcF (ΔΔQTcS, ΔΔQTcI, ΔΔQTcP, ΔΔQTcF) if not selected as the primary endpoint
Measured: 24 Hours
Categorical summary for QTcF, heart rate, pulse rate, and QRS intervals
Measured: 24 Hours
If a substantial heart rate (HR) effect is observed: Categorical summary for QTcS, QTcI, and QTcP
Measured: 24 Hours
Frequency of treatment-emergent changes of T-wave morphology and U-waves presence.
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start18 Jun 2020
- Primary completion10 Nov 2020
- Study completion10 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects will be randomized using a double Williams design in equal ratio to six possible sequences of receiving the three treatments being studied: SEP-363856 150mg, Matched Placebo, moxifloxacin 400mg.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369391
- Sponsor's protocol ID
- SEP361-114
- Status last verified
- Jun 2024
- First submitted
- 27 Apr 2020
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-dose, Crossover Study of the Effects of SEP-363856 on Electrocardiogram (ECG) Intervals in Subjects With Schizophrenia
- ClinicalTrials.gov ID
- NCT04369391
- Acronym / sponsor ID
- SEP361-114
- Conditions
- Schizophrenia
- Keywords
- schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- 10 Nov 2020 (actual)
- Study completion
- 10 Nov 2020 (actual)
- First posted
- 30 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase 1, randomized, single-dose, active and placebo controlled, 3-period crossover study of the effect of SEP-363856 150 mg on electrocardiogram (ECG) intervals in subjects with schizophrenia. SEP-363856 and matching placebo will be utilized in a double-blind fashion. Moxifloxacin will be utilized as an active control in an open-label fashion.
The primary analysis will be based on concentration-QTc modeling of the relationship between plasma concentrations of SEP-363856 or its metabolite SEP-363854 and change-from baseline QTc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Subjects will be randomized using a double Williams design in equal ratio to six possible sequences of receiving the three treatments being studied: SEP-363856 150mg, Matched Placebo, moxifloxacin 400mg.
| Arm | Type | Receives |
|---|---|---|
| SEP363856 150 mg | Experimental | Drug: SEP363856 150 mgSEP363856 tablet 150 mg |
| Placebo | Placebo comparator | Drug: Placebomatched placebo |
| moxifloxacin 400 mg | Active comparator | Drug: moxifloxacin 400 mgmoxifloxacin tablet 400 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SEP363856 150 mgSEP363856 tablet 150 mg | Drug | SEP363856 150 mg |
| PlaceboPlacebo tablet | Drug | Placebo |
| moxifloxacin 400 mgmoxifloxacin tablet 400 mg | Drug | moxifloxacin 400 mg |
Primary outcome
Placebo-adjusted change-from-baseline QTc interval (ΔΔQTc)
Time frame: 24 Hours
7 secondary outcomes
Change from baseline in heart rate, QTcF, pulse rate, and QRS intervals (∆HR, ΔQTcF, ΔPR, and ∆QRS)
Time frame: 24 Hours
If a substantial heart rate (HR) effect is observed: Change from baseline in QTcS, QTcI, and QTcP (ΔQTcS, ΔQTcI, and ΔQTcP)
Time frame: 24 Hours
Placebo-adjusted change from baseline in heart rate, pulse rate, and QRS intervals (ΔΔHR, ΔΔPR, and ΔΔQRS)
Time frame: 24 Hours
If a substantial heart rate (HR) effect is observed: Placebo-adjusted ΔQTcS, and/or ΔQTcI, and/or ΔQTcP, and/or ΔQTcF (ΔΔQTcS, ΔΔQTcI, ΔΔQTcP, ΔΔQTcF) if not selected as the primary endpoint
Time frame: 24 Hours
Categorical summary for QTcF, heart rate, pulse rate, and QRS intervals
Time frame: 24 Hours
If a substantial heart rate (HR) effect is observed: Categorical summary for QTcS, QTcI, and QTcP
Time frame: 24 Hours
Frequency of treatment-emergent changes of T-wave morphology and U-waves presence.
Time frame: 24 Hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Individual participant dataSharing planned: Yes. Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SEP363856 150 mg and moxifloxacin 400 mg in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Placebo-adjusted change-from-baseline QTc interval (ΔΔQTc) (time frame: 24 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.