Back to results

A Clinical Study That Will Assess the Effect of SEP-363856 or Prior Antipsychotic (PA) Standard of Care on Body-weight Associated Parameters in Subjects With Schizophrenia

Primary Purpose

Schizophrenia

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

SEP-363856

Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole)

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

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

Inclusion Criteria: This is not an all inclusive list

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 Positive and negative symptoms scale (PANSS) total score ≤ 80 at Screening and a score of ≤ 4 on the following PANSS items at Screening: P7 (hostility) and G8 (uncooperativeness)
Subject must have a Clinical Global Impressions - Severity (CGI-S) score ≤ 4 (normal to moderately ill) at Screening.
Subject must be receiving risperidone, olanzapine, quetiapine or aripiprazole as treatment for schizophrenia at the time of Screening.

Exclusion Criteria: This is not an all inclusive list

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 GroupRecruiting
Shari DeSilvaRecruiting
Midwest Clinical Research CenterRecruiting
Endeavor Clinical TrialsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole)

SEP-363856

Arm Description

Outcomes

Primary Outcome Measures

Insulin stimulated change in glucose disposal rate during the steady state of the low dose hyperinsulinemic euglycemic clamp (HEC), baseline to end of the treatment

Insulin stimulated change in glucose disposal rate during the steady state of the high dose hyperinsulinemic euglycemic clamp (HEC) baseline to end of the treatment.

Change in liver proton density fat fraction (PDFF), baseline to end of the treatment

Change in fat content in muscles of interest, baseline to end of the treatment

Change in Liver Fibroinflammation, baseline to end of the treatment

Change in Liver Volume from baseline to end of treatment

Secondary Outcome Measures

Full Information

NCT ID

NCT05542264

First Posted

August 15, 2022

Last Updated

May 5, 2023

Sponsor

Sumitomo Pharma America, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05542264

Brief Title

A Clinical Study That Will Assess the Effect of SEP-363856 or Prior Antipsychotic (PA) Standard of Care on Body-weight Associated Parameters in Subjects With Schizophrenia

Official Title

A Double-Blind, Randomized, Multiple Dose Study of Weight 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

November 15, 2022 (Actual)

Primary Completion Date

October 23, 2023 (Anticipated)

Study Completion Date

October 23, 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

Data Monitoring Committee

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 wether it affectsbody-weight associated parameters. This study is accepting male and female participants age 18 years to 65 years. This study will be conducted in approximately 6 study sites in the United States. Participation could last up to 13 weeks.

Detailed Description

This is a double-blind, randomized, multiple dose study in male and female adult subjects with schizophrenia. Subjects will undergo structural magnetic resonance abdominal imaging (MRI) scans as well as hyperinsulinemic euglycemic clamp (HEC) also known as "glucose clamp", after the check-in and towards the end of the treatment phase. Subjects will be randomized to SEP-363856 or their prior antipsychotic (PA). Subjects randomized to SEP-363856 will undergo blinded wash out of their PA, subsequent SEP-363856 blinded titration and 15 day of well tolerated SEP-363856 exposure. Subjects randomized to their prior antipsychotic (PA), will undergo pseudo PA washout, followed by pseudo-titration and 15 day of well tolerated PA exposure. Subjects will be discharged after subject is stable. All subjects will return to the clinic 7 + 2 days post discharge for follow-up assessments.

6. Conditions and Keywords

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

Schizophrenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

Double-Blind, Randomized, Multiple Dose

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Double Blind

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole)

Arm Type

Active Comparator

Arm Title

SEP-363856

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

SEP-363856

Intervention Description

SEP-363856 will be supplied as over-encapsulated tablets. Multiple tablets may be required to achieve a single dose.

Intervention Type

Drug

Intervention Name(s)

Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole)

Intervention Description

PA will be prepared by the pharmacy staff according to the patient's prescribed treatment and will be orally administered. Multiple tablets or capsules may be required to achieve a single dose.

Primary Outcome Measure Information:

Title

Insulin stimulated change in glucose disposal rate during the steady state of the low dose hyperinsulinemic euglycemic clamp (HEC), baseline to end of the treatment

Time Frame

up to 8 weeks

Title

Insulin stimulated change in glucose disposal rate during the steady state of the high dose hyperinsulinemic euglycemic clamp (HEC) baseline to end of the treatment.

Time Frame

up to 8 weeks

Title

Change in liver proton density fat fraction (PDFF), baseline to end of the treatment

Time Frame

up to 8 weeks

Title

Change in fat content in muscles of interest, baseline to end of the treatment

Time Frame

up to 8 weeks

Title

Change in Liver Fibroinflammation, baseline to end of the treatment

Time Frame

up to 8 weeks

Title

Change in Liver Volume from baseline to end of treatment

Time Frame

up to 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: This is not an all inclusive list 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 Positive and negative symptoms scale (PANSS) total score ≤ 80 at Screening and a score of ≤ 4 on the following PANSS items at Screening: P7 (hostility) and G8 (uncooperativeness) Subject must have a Clinical Global Impressions - Severity (CGI-S) score ≤ 4 (normal to moderately ill) at Screening. Subject must be receiving risperidone, olanzapine, quetiapine or aripiprazole as treatment for schizophrenia at the time of Screening. Exclusion Criteria: This is not an all inclusive list 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

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 Chair

Facility Information:

Facility Name

Woodland International Research Group

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

Shari DeSilva

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

Midwest Clinical Research Center

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45417

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Richard D Sanders, MD

Phone

937-424-1050

Facility Name

Endeavor Clinical Trials

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78240

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nitendra Agarwal, MD

Phone

210-949-0807

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 or Prior Antipsychotic (PA) Standard of Care on Body-weight Associated Parameters in Subjects With Schizophrenia

We'll reach out to this number within 24 hrs