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A Clinical Study That Will Assess the Effect of SEP-363856 and Prior Antipsychotic (PA) Standard of Care on Glucose and Regulation of Insulin in Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SEP-363856
Sponsored by
Sumitomo Pharma America, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: (this list is not all inclusive)

  • Male or female subjects between 18 and 65 years of age, inclusive at time of consent.
  • Subject meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for a primary diagnosis of schizophrenia as established by clinical interview, using the DSM-5 as a reference and confirmed using the Structured Clinical Interview for DSM-5, Clinical Trials Version [SCID-CT]).
  • Subject must have a CGI-S score ≤ 4 (normal to moderately ill) at Screening
  • Subject must have a PANSS total score ≤ 80 at Screening and a score of ≤ 4 on the following PANSS items at Screening: P7 (hostility) and G8 (uncooperativeness)
  • Subjects' antipsychotic medication at screening must have had no dose change (minor dose adjustments for tolerability purposes are permitted) for at least eight weeks prior to the Screening visit.

Exclusion Criteria: (this list is not all inclusive)

-- Subject has a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia or intellectual disability (IQ < 70).

  • Subject has attempted suicide within 12 months prior to Screening.
  • Subject answers "yes" to "Suicidal Ideation" Items 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS at Screening (ie. in the past 1 month) or at any subsequent C-SSRS assessment prior to dosing (ie, since last visit).
  • Subject is at risk of harming him/herself or others according to the Investigator's judgment.

Sites / Locations

  • Woodland International Research Group, LLCRecruiting
  • Woodland Research Northwest, LLCRecruiting
  • Collaborative Neuroscience Research, LLCRecruiting
  • Catalina Research Institute LLCRecruiting
  • CNRI - San Diego LLCRecruiting
  • Galiz ResearchRecruiting
  • Neuro-Behavioral Clinical Research, Inc.Recruiting
  • Pillar Clinical Research, LLCRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SEP-363856

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline (PA) in oGTT derived plasma AUC0-120 min of glucose, insulin, c-peptide in oGTT to stable dose (SEP-363856) period assessment.
Change from baseline (PA) in mixed meal tolerance test (MMTT) derived plasma AUC0-240 min of glucose, insulin, c-peptide and β-cell responsivity index to stable dose (SEP-363856) period assessment.

Secondary Outcome Measures

Change from baseline (PA) in plasma AUC0-240 min
Change in Cmax of acetaminophen levels to stable dose (SEP-363856) period assessment.
Change in gastric emptying terminal elimination half-life (T1/2), baseline to stable dose (SEP-363856) period assessment.
Change in kPCD, baseline to stable dose (SEP-363856) period assessment
Change in the Visual Analog Scale (VAS) of fullness, hunger and satiety, baseline - repeat test (PA baseline to SEP-363856 stable dose period assessment) for all time points.
Visual Analog Scale (VAS) is on a scale of 0-100, higher represents higher pain intensity (higher score represents worse outcome).
Change in lag time, baseline to stable dose (SEP-363856) period assessment

Full Information

First Posted
July 6, 2022
Last Updated
May 5, 2023
Sponsor
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05463770
Brief Title
A Clinical Study That Will Assess the Effect of SEP-363856 and Prior Antipsychotic (PA) Standard of Care on Glucose and Regulation of Insulin in Patients With Schizophrenia
Official Title
An Open-Label, Fixed Sequence, Multiple Dose Study of Glucose and Insulin Associated Parameters: SEP-363856 vs Prior Antipsychotic (PA) Standard of Care in Subjects With Schizophrenia Suffering From Metabolic Dysregulation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma America, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A Clinical Study that will look at an investigational medication, SEP-363856 (called "study medication") in patients with schizophrenia and assess whether it changes: how the body processes (uses) glucose (blood sugar) how much insulin the pancreas can make. Insulin is a hormone that lowers blood sugar levels in the body. The information from this study will help to understand any effect the study medication may have on how the body uses and stores glucose. This study is accepting both male and female subjects. It will be held in approximately 6 locations in the United States. Participation could last up to 12 weeks.
Detailed Description
This is an open-label, fixed sequence, multiple dose design. Following screening evaluations, subjects will check-in to the clinical research unit. After confirmation of continuation criteria, subjects will undergo an oral glucose tolerance test (oGTT), mixed meal tolerance test (MMTT) and spirulina breath test (GEBT). After these assessments are completed, subjects will have their prior antipsychotic (PA) or any other medication with psychotropic propensity washed out (dependent on their antipsychotic elimination half-life). Subjects will undergo SEP-363856 titration schedule, followed by the oGTT, MMTT and GEBT tests during the SEP-363856 Stable Dose Period. Subjects will be stabilized on their prior antipsychotic, discharged from the clinical research unit, and return to the unit for the follow-up visit 7 + 2 days after discharge.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
This is an open-label, fixed sequence, multiple dose design.
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SEP-363856
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SEP-363856
Intervention Description
SEP-363856, 12.5 mg, 25 mg, and 50 mg tablets. The dose taken at the same time each day, in the evening and in the morning. Multiple tablets may be required to achieve a single dose.
Primary Outcome Measure Information:
Title
Change from baseline (PA) in oGTT derived plasma AUC0-120 min of glucose, insulin, c-peptide in oGTT to stable dose (SEP-363856) period assessment.
Time Frame
PA Baseline and SEP-363856 Stable Dose Period (up to 48 days)
Title
Change from baseline (PA) in mixed meal tolerance test (MMTT) derived plasma AUC0-240 min of glucose, insulin, c-peptide and β-cell responsivity index to stable dose (SEP-363856) period assessment.
Time Frame
PA Baseline and SEP-363856 Stable Dose Period (up to 48 days)
Secondary Outcome Measure Information:
Title
Change from baseline (PA) in plasma AUC0-240 min
Time Frame
PA Baseline and SEP-363856 Stable Dose Period (up to 48 days)
Title
Change in Cmax of acetaminophen levels to stable dose (SEP-363856) period assessment.
Time Frame
PA Baseline and SEP-363856 Stable Dose Period (up to 48 days)
Title
Change in gastric emptying terminal elimination half-life (T1/2), baseline to stable dose (SEP-363856) period assessment.
Time Frame
PA Baseline and SEP-363856 Stable Dose Period (up to 48 days)
Title
Change in kPCD, baseline to stable dose (SEP-363856) period assessment
Time Frame
PA Baseline and SEP-363856 Stable Dose Period (up to 48 days)
Title
Change in the Visual Analog Scale (VAS) of fullness, hunger and satiety, baseline - repeat test (PA baseline to SEP-363856 stable dose period assessment) for all time points.
Description
Visual Analog Scale (VAS) is on a scale of 0-100, higher represents higher pain intensity (higher score represents worse outcome).
Time Frame
PA Baseline and SEP-363856 Stable Dose Period (up to 48 days)
Title
Change in lag time, baseline to stable dose (SEP-363856) period assessment
Time Frame
PA Baseline and SEP-363856 Stalbe Dose Period (up to 48 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (this list is not all inclusive) Male or female subjects between 18 and 65 years of age, inclusive at time of consent. Subject meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for a primary diagnosis of schizophrenia as established by clinical interview, using the DSM-5 as a reference and confirmed using the Structured Clinical Interview for DSM-5, Clinical Trials Version [SCID-CT]). Subject must have a CGI-S score ≤ 4 (normal to moderately ill) at Screening Subject must have a PANSS total score ≤ 80 at Screening and a score of ≤ 4 on the following PANSS items at Screening: P7 (hostility) and G8 (uncooperativeness) Subjects' antipsychotic medication at screening must have had no dose change (minor dose adjustments for tolerability purposes are permitted) for at least eight weeks prior to the Screening visit. Exclusion Criteria: (this list is not all inclusive) -- Subject has a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia or intellectual disability (IQ < 70). Subject has attempted suicide within 12 months prior to Screening. Subject answers "yes" to "Suicidal Ideation" Items 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS at Screening (ie. in the past 1 month) or at any subsequent C-SSRS assessment prior to dosing (ie, since last visit). Subject is at risk of harming him/herself or others according to the Investigator's judgment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CNS Medical Director
Phone
1-866-503-6351
Email
ClinicalTrialDisclosure@sunovion.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CNS Medical Director
Organizational Affiliation
Sumitomo Pharma America, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Woodland International Research Group, LLC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Konis, MD
Phone
501-221-8681
Facility Name
Woodland Research Northwest, LLC
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shari DeSilva, MD
Phone
479-927-3000
Facility Name
Collaborative Neuroscience Research, LLC
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haig Goenjian, MD
Phone
714-799-7799
Facility Name
Catalina Research Institute LLC
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Volk, MD
Phone
909-590-6306
Facility Name
CNRI - San Diego LLC
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Benbow, MD
Phone
619-481-5252
Facility Name
Galiz Research
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Gamez, MD
Phone
305-805-0921
Facility Name
Neuro-Behavioral Clinical Research, Inc.
City
North Canton
State/Province
Ohio
ZIP/Postal Code
44720
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shishuka Malhotra, MD
Phone
330-493-1118
Facility Name
Pillar Clinical Research, LLC
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Bartley, MD
Phone
214-396-4844

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study may be made available upon request via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD will be made available upon request within 12 months of posting the study results on ct.gov.
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing URL
http://clinicalstudydatarequest.com

Learn more about this trial

A Clinical Study That Will Assess the Effect of SEP-363856 and Prior Antipsychotic (PA) Standard of Care on Glucose and Regulation of Insulin in Patients With Schizophrenia

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